Effective medications exist to treat opioid use disorder: methadone, buprenorphine, and naltrexone. Learn how these medications could help people recover from opioid use disorder.
Bottle of methadone
Image by Abulic Monkey
Overview
Naloxone-buprenorphine 2mg tablet
Image by Tmeers91/Wikimedia
Naloxone-buprenorphine 2mg tablet
This tablet is a combination of buprenorphine and naloxone, and is a generic drug available in the US. Used in the treatment of opioid dependence. Manufactured by Roxane Laboratories.
Image by Tmeers91/Wikimedia
Medications to Treat Opioid Use Disorder
In 2020, an estimated 2.7 million people aged 12 or older, in the United States had an opioid use disorder (OUD) in the past 12 months—including 2.3 million people with a prescription opioid use disorder. Overdose deaths involving prescription opioids more than quadrupled from 1999 through 2016 followed by significant declines reported in both 2018 and 2019, and then an increase in 2020. Besides overdose, consequences of the opioid crisis include a rising incidence of infants born dependent on opioids because their mothers used these substances during pregnancy and increased spread of infectious diseases, including HIV and hepatitis C (HCV), as was seen in 2015 in southern Indiana.
Effective prevention and treatment strategies exist for opioid misuse and use disorder but are highly underutilized across the United States. An initiative of the Secretary of Health and Human Services (HHS) began in 2015 to address the complex problem of prescription opioid and heroin use. In 2017, HHS announced five priorities for addressing the opioid crisis:
improving access to treatment and recovery services
promoting use of overdose-reversing drugs
strengthening our understanding of the epidemic through better public health surveillance
providing support for cutting-edge research on pain and addiction
advancing better practices for pain management
Effective medications exist to treat opioid use disorder: methadone, buprenorphine, and naltrexone. These medications could help many people recover from opioid use disorder, but they remain highly underutilized. Fewer than half of private-sector treatment programs offer medications for opioid use disorders, and of patients in those programs who might benefit, only a third actually receive it. Overcoming the misunderstandings and other barriers that prevent wider adoption of these treatments is crucial for tackling the problem of opioid use disorder and the epidemic of opioid overdose in the United States.
Source: National Institute on Drug Abuse (NIDA)
Additional Materials (11)
Medication Assisted Treatment
Video by NYS OASAS/YouTube
Opioid Treatment Options
Video by Psych Hub/YouTube
5 former opioid users share their experience with medication-assisted treatment
Video by PBS NewsHour/YouTube
Medication Treatment of Opioid Use Disorder
Video by University of California Television (UCTV)/YouTube
Managing and Treating Opioid-Induced Constipation
Video by You and Constipation/YouTube
Introduction to Medications for the Treatment of Opioid Use Disorder
Video by Washington State Health Care Authority/YouTube
Medications for Opioid Use Disorder
Video by National Institute on Drug Abuse (NIDA/NIH)/YouTube
Detoxing in Jail: Treating Opioid Use Behind Bars | NBC Left Field
Video by NBC News/YouTube
Medication-assisted treatments for opioid addictions
Video by Harvard Health Publishing/YouTube
How Opioid Treatment Medications Work On Your Brain | San Diego Union-Tribune
Video by The San Diego Union-Tribune/YouTube
Understanding Opioid Addiction Treatment and Types of Medications | Mass General Brigham
Video by Mass General Brigham/YouTube
3:38
Medication Assisted Treatment
NYS OASAS/YouTube
3:25
Opioid Treatment Options
Psych Hub/YouTube
4:01
5 former opioid users share their experience with medication-assisted treatment
PBS NewsHour/YouTube
59:36
Medication Treatment of Opioid Use Disorder
University of California Television (UCTV)/YouTube
5:19
Managing and Treating Opioid-Induced Constipation
You and Constipation/YouTube
10:30
Introduction to Medications for the Treatment of Opioid Use Disorder
Washington State Health Care Authority/YouTube
3:42
Medications for Opioid Use Disorder
National Institute on Drug Abuse (NIDA/NIH)/YouTube
9:31
Detoxing in Jail: Treating Opioid Use Behind Bars | NBC Left Field
NBC News/YouTube
4:19
Medication-assisted treatments for opioid addictions
Harvard Health Publishing/YouTube
2:22
How Opioid Treatment Medications Work On Your Brain | San Diego Union-Tribune
The San Diego Union-Tribune/YouTube
6:53
Understanding Opioid Addiction Treatment and Types of Medications | Mass General Brigham
Mass General Brigham/YouTube
Buprenorphine
Buprenorphine
Also called: Buprenex®
Buprenorphine is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
Buprenorphine
Also called: Buprenex®
Buprenorphine is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
Buprenorphine hydrochloride sublingual tablets can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
You feel faint, dizzy or confused
Your breathing gets much slower than is normal for you
These can be signs of an overdose or other serious problems.
Do not switch from buprenorphine hydrochloride sublingual tablets to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine hydrochloride sublingual tablets may not be the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine hydrochloride sublingual tablets that may be different than other buprenorphine containing medicines you may have been taking.
Buprenorphine hydrochloride sublingual tablets contain an opioid that can cause physical dependence.
Do not stop taking buprenorphine hydrochloride sublingual tablets without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine
Physical dependence is not the same as drug addiction
Buprenorphine hydrochloride sublingual tablets are not for occasional or “as needed” use
An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using buprenorphine hydrochloride sublingual tablets. Ask your doctor what you should do if you are taking one of these.
Call a doctor or get emergency help right away if you:
Feel sleepy and uncoordinated
Have blurred vision
Have slurred speech
Cannot think well or clearly
Have slowed reflexes and breathing
Do not inject (“shoot-up”) buprenorphine hydrochloride sublingual tablets.
Injecting buprenorphine hydrochloride sublingual tablets may cause life-threatening infections and other serious health problems.
Injecting buprenorphine hydrochloride sublingual tablets may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine hydrochloride sublingual tablets.
Buprenorphine hydrochloride sublingual tablets are a prescription medicine used to begin treatment in adults who are addicted to (dependent on) opioid drugs (either prescription or illegal drugs), as part of a complete treatment program that also includes counseling and behavioral therapy.
Buprenorphine hydrochloride sublingual tablets are most often used for the first 1 or 2 days to help you start with treatment.
It is not known if buprenorphine hydrochloride sublingual tablets are safe or effective in children.
Buprenorphine hydrochloride sublingual tablets are a controlled substance (CIII) because they contain buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your buprenorphine hydrochloride sublingual tablets in a safe place to protect them from theft. Never give your buprenorphine hydrochloride sublingual tablets to anyone else; they can cause death or harm them. Selling or giving away this medicine is against the law.
Do not take buprenorphine hydrochloride sublingual tablets if you are allergic to buprenorphine.
Buprenorphine hydrochloride sublingual tablets may not be right for you. Before taking buprenorphine hydrochloride sublingual tablets, tell your doctor if you:
Have liver or kidney problems
Have trouble breathing or lung problems
Have an enlarged prostate gland (men)
Have a head injury or brain problem
Have problems urinating
Have a curve in your spine that affects your breathing
Have gallbladder problems
Have adrenal gland problems
Have Allison’s disease
Have low thyroid (hypothyroidism)
Have a history of alcoholism
Have mental problems such as hallucinations (seeing or hearing things that are not there)
Have any other medical condition
Are pregnant or plan to become pregnant. If you take buprenorphine hydrochloride sublingual tablets while pregnant, your baby may have symptoms of opioid withdrawal or respiratory depression at birth. Talk to your doctor if you are pregnant or plan to become pregnant.
Are breastfeeding or plan to breastfeed. Buprenorphine hydrochloride can pass into your milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take buprenorphine hydrochloride sublingual tablets. Monitor your baby for increased sleepiness and breathing problems.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Buprenorphine hydrochloride sublingual tablets may affect the way other medicines work, and other medicines may affect how buprenorphine hydrochloride sublingual tablets work. Some medicines may cause serious or life-threatening medical problems when taken with buprenorphine hydrochloride sublingual tablets.
Sometimes the doses of certain medicines and buprenorphine hydrochloride sublingual tablets may need to be changed if used together. Do not take any medicine while using buprenorphine hydrochloride sublingual tablets until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are taking buprenorphine hydrochloride sublingual tablets.
Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, sleeping pills, anxiety medicines or antihistamines.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.
Always take buprenorphine hydrochloride sublingual tablets exactly as your doctor tells you. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.
Do not take buprenorphine hydrochloride sublingual tablets more often than prescribed by your doctor.
If you are prescribed a dose of 2 or more buprenorphine hydrochloride sublingual tablets at the same time:
Ask your doctor for instructions on the right way to take buprenorphine hydrochloride sublingual tablets
Follow the same instructions every time you take a dose of buprenorphine hydrochloride sublingual tablets
Put the tablets under your tongue. Let them dissolve completely.
While buprenorphine hydrochloride sublingual tablets are dissolving, do not chew or swallow the tablet because the medicine will not work as well.
Talking while the tablet is dissolving can affect how well the medicine in buprenorphine hydrochloride sublingual tablets is absorbed.
If you miss a dose of buprenorphine hydrochloride sublingual tablets, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
Do not stop taking buprenorphine hydrochloride sublingual tablets suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using buprenorphine hydrochloride sublingual tablets the right way.
If you take too many buprenorphine hydrochloride sublingual tablets or overdose, call Poison Control or get emergency medical help right away.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take buprenorphine hydrochloride sublingual tablets.
You should not drink alcohol while using buprenorphine hydrochloride sublingual tablets, as this can lead to loss of consciousness or death.
Buprenorphine hydrochloride sublingual tablets can cause serious side effects including:
See “What is the most important information I should know about buprenorphine?”
Respiratory problems. You have a higher risk of death and coma if you take buprenorphine hydrochloride sublingual tablets with other medicines, such as benzodiazepines.
Sleepiness, dizziness, and problems with coordination
Dependency or abuse
Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take buprenorphine hydrochloride sublingual tablets.
Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches. Tell your doctor if you develop any of these symptoms.
Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
Common side effects of buprenorphine hydrochloride sublingual tablets include:
Nausea
Vomiting
Drug withdrawal syndrome
Headache
Sweating
Numb mouth
Constipation
Swollen and/or painful tongue
The inside of your mouth is more red than normal
Intoxication (feeling lightheaded or drunk)
Disturbance in attention
Irregular heart beat (palpitations)
Decrease in sleep (insomnia)
Blurred vision
Back pain
Fainting
Dizziness
Sleepiness
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects of buprenorphine hydrochloride sublingual tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects.
Store buprenorphine hydrochloride sublingual tablets at room temperature between 20º to 25ºC (68º to 77ºF).
Keep buprenorphine hydrochloride sublingual tablets in a safe place, out of the sight and reach of children.
Dispose of unused buprenorphine hydrochloride sublingual tablets as soon as you no longer need them.
Unused tablets should be flushed down the toilet.
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- buprenorphine hydrochloride sublingual tablet REMEDYREPACK INC.. Medication Guide. [accessed on Oct 24, 2018]
Buprenorphine Sublingual and Buccal (opioid dependence): MedlinePlus Drug Information [accessed on Oct 26, 2018]
These FAQs provide a summary of the most important information about Buprenorphine. The drug should not be used for a condition other than that for which it is prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information or have any questions, talk to your healthcare provider.
Additional Materials (1)
Buprenorphine implants; A new implant treatment for addicts
Video by CBS Evening News/YouTube
2:08
Buprenorphine implants; A new implant treatment for addicts
CBS Evening News/YouTube
Methadone
Methadone
Also called: Dolophine®, Diskets®, Methadose®, Westadone®
Methadone is a prescription medicine used for the treatment of moderate to severe pain not responsive to non-narcotic analgesics. It is also used in medication-assisted treatment (MAT) to help people reduce or quit their use of heroin or other opiates.
Methadone
Also called: Dolophine®, Diskets®, Methadose®, Westadone®
Methadone is a prescription medicine used for the treatment of moderate to severe pain not responsive to non-narcotic analgesics. It is also used in medication-assisted treatment (MAT) to help people reduce or quit their use of heroin or other opiates.
Get emergency help right away if you take too much methadone hydrochloride (overdose). When you first start taking methadone hydrochloride, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Never give anyone your methadone hydrochloride. They could die from taking it. Store methadone hydrochloride away from children and in a safe place to prevent stealing or abuse. Selling or giving away methadone hydrochloride is against the law.
Methadone hydrochloride is:
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Not for use to treat pain that is not around-the-clock.
Also used to manage drug addiction.
Do not take methadone hydrochloride if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
Before taking methadone hydrochloride, tell your healthcare provider if you have a history of:
head injury, seizures
liver, kidney, thyroid problems
problems urinating
pancreas or gallbladder problems
heart rhythm problems (Long QT syndrome)
abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of methadone hydrochloride during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Methadone hydrochloride passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking methadone hydrochloride with certain other medicines may cause serious side effects.
When taking methadone hydrochloride:
Do not change your dose. Take methadone hydrochloride exactly as prescribed by your healthcare provider.
Do not take more than your prescribed dose in 24 hours. If you take methadone hydrochloride for pain and miss a dose, take methadone hydrochloride as soon as possible and then take your next dose 8 or 12 hours later as directed by your healthcare provider. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you take methadone hydrochloride for opioid addiction and miss a dose, take your next dose the following day as scheduled. Do not take extra doses. Taking more than the prescribed dose may cause you to overdose because methadone hydrochloride builds up in your body over time.
Do not crush, dissolve, snort or inject methadone hydrochloride because this may cause you to overdose and die.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking methadone hydrochloride without talking to your healthcare provider.
After you stop taking methadone hydrochloride, flush any unused tablets down the toilet.
While taking methadone hydrochloride do not:
Drive or operate heavy machinery, until you know how methadone hydrochloride affects you. Methadone hydrochloride can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with methadone hydrochloride may cause you to overdose and die.
Do not take other medicines with methadone hydrochloride tablets without first talking with your doctor.
The possible side effects of methadone hydrochloride are:
constipation
nausea
sleepiness
vomiting
tiredness
headache
dizziness
abdominal pain
Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
trouble breathing
shortness of breath
fast heartbeat
chest pain
swelling of your face, tongue or throat
extreme drowsiness
light-headedness when changing positions
feeling faint.
These are not all the possible side effects of methadone hydrochloride. Call your doctor for medical advice about side effects.
Keep methadone hydrochloride tablets in a safe place away from children. Accidental use by a child is a medical emergency that can result in death. If a child accidentally takes methadone hydrochloride tablets, get emergency help right away.
Keep methadone hydrochloride tablets at room temperature, 68° to 77°F (20° to 25°C).
Always keep methadone hydrochloride tablets in a secure place to protect from theft.
Dispose of any unused methadone hydrochloride tablets remaining from a prescription as soon as they are no longer needed. Unused tablets should be flushed down the toilet.
METHADONE HYDROCHLORIDE- methadone hydrochloride tablet Bryant Ranch Prepack. Medication Guide. [accessed on Oct 23, 2018]
LABEL: METHADONE HYDROCHLORIDE - methadone hydrochloride tablet [accessed on Oct 23, 2018]
DOLOPHINE- methadone hydrochloride tablet West-Ward Pharmaceuticals Corp.. Medication Guide. [accessed on Oct 23, 2018]
ROXANE LABORATORIES, INC. Columbus, OH 43216 DOLOPHINE® HYDROCHLORIDE CII [accessed on Oct 23, 2018]
Methadone | SAMHSA - Substance Abuse and Mental Health Services Administration [accessed on Jan 15, 2019]
Methadone. MedlinePlus/AHFS® Drug Information. [accessed on Oct 28, 2018]
These FAQs provide a summary of the most important information about Methadone. If you would like more information or have any questions, talk to your healthcare provider.
Additional Materials (15)
Bottle of methadone
bottle of methadone
Image by Abulic Monkey
Methadone Molecule
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE.
Image by TheVisualMD
Opioid use disorder
The contents of a needle exchange kit.The items are (also annotated in the picture), from the top clockwise: a torniquet, cotton balls, a pot for cooking drugs, a condom, sterile water, alcohol swabs, and (from l-r) a thin needle, a thinner needle, and the thinnest needle.Multiple needles of different bore sizes are included. Reason: The viscosity of drugs can be radically different, i.e. methadone is more viscous than heroin which is more viscous than cocaine. Pushing methadone through a small needle is impossible.
Image by Todd Huffman from Phoenix, AZ
Opiates
Opium poppy Papaver somniferum Field in Turkey
Image by Marknesbitt assumed (based on copyright claims).Credit: Mark Nesbitt and Delwen Samuel
Opioid use disorder
Image by Erik Fenderson
Suboxone
Suboxone tablet - both sides.
Image by Supertheman
Fentanyl
Stick model of the fentanyl molecule in the crystal structure of fentanyl citrate-toluene solvate.
Image by Ben Mills
Opioids Mechanism of Action, Addiction, Dependence and Tolerance, Animation
Video by Alila Medical Media/YouTube
Why We Have Pain, & How We Kill It
Video by SciShow/YouTube
How Opioid Treatment Medications Work On Your Brain | San Diego Union-Tribune
Video by The San Diego Union-Tribune/YouTube
What Is Methadose aka Methadone? | Addictions
Video by Howcast/YouTube
Medication-Assisted Treatment Overview: Naltrexone, Methadone & Suboxone l The Partnership
Video by Partnership to End Addiction/YouTube
Using opioids to beat back an addiction to them
Video by STAT/Vimeo
Beyond Addiction | The Center For Addiction and Pregnancy
Video by Johns Hopkins Medicine/YouTube
The best opioid addiction treatment is more opioids
Video by VICE News/YouTube
Bottle of methadone
Abulic Monkey
Methadone Molecule
TheVisualMD
Opioid use disorder
Todd Huffman from Phoenix, AZ
Opiates
Marknesbitt assumed (based on copyright claims).Credit: Mark Nesbitt and Delwen Samuel
Opioid use disorder
Erik Fenderson
Suboxone
Supertheman
Fentanyl
Ben Mills
3:24
Opioids Mechanism of Action, Addiction, Dependence and Tolerance, Animation
Alila Medical Media/YouTube
10:05
Why We Have Pain, & How We Kill It
SciShow/YouTube
2:22
How Opioid Treatment Medications Work On Your Brain | San Diego Union-Tribune
The San Diego Union-Tribune/YouTube
1:27
What Is Methadose aka Methadone? | Addictions
Howcast/YouTube
5:17
Medication-Assisted Treatment Overview: Naltrexone, Methadone & Suboxone l The Partnership
Partnership to End Addiction/YouTube
3:13
Using opioids to beat back an addiction to them
STAT/Vimeo
3:45
Beyond Addiction | The Center For Addiction and Pregnancy
Johns Hopkins Medicine/YouTube
2:39
The best opioid addiction treatment is more opioids
VICE News/YouTube
Naltrexone
Naltrexone
Also called: ReVia®
Naltrexone is a prescription medicine used in medication-assisted treatment (MAT) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD). Naltrexone is available in a pill form (ReVia) for AUD or as an extended-release intramuscular injectable (Vivitrol) for AUD and OUD.
Naltrexone
Also called: ReVia®
Naltrexone is a prescription medicine used in medication-assisted treatment (MAT) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD). Naltrexone is available in a pill form (ReVia) for AUD or as an extended-release intramuscular injectable (Vivitrol) for AUD and OUD.
Patients should tell family and the people they are closest to about the increased sensitivity to opioids and the risk of overdose. Accidental overdose can happen in two ways:
Naltrexone blocks the effects of opioids, such as heroin or opioid pain medicines. Patients who try to overcome this blocking effect by taking large amounts of opioids may experience serious injury, coma, or death.
After receiving a dose of naltrexone, the blocking effect slowly decreases and completely goes away over time. Patients who are taking naltrexone for an opioid use disorde can become more sensitive to the effects of opioids at the dose used before, or even lower amounts. Using opioids while on naltrexone can lead to overdose and death.
Naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD).
Naltrexone can be prescribed and administered by any practitioner licensed to prescribe medications, and is available in a pill form for Alcohol Use disorder or as an extended-release intramuscular injectable for AUD and OUD. A Risk Evaluation and Mitigation Strategy (REMS) is required for the long acting injectable formulation to ensure that the benefits of the drug outweigh its risks. The pill form can be taken daily for AUD, but the extended-release injectable formulation is approved for the treatment of OUD. The pill form is taken daily and the extended-release injectable is administered every four weeks, or once a month, by a practitioner.
Naltrexone is one component of a comprehensive treatment plan, which includes counseling and other behavioral health therapies to provide patients with a whole-person approach. Naltrexone is not a recommended option for anyone younger than 18 years of age, or for patients experiencing other health conditions.
Naltrexone is not an opioid, is not addictive, and does not cause withdrawal symptoms with stop of use. Naltrexone blocks the euphoric and sedative effects of opioids such as heroin, morphine, and codeine. Naltrexone binds and blocks opioid receptors, and reduces and suppresses opioid cravings. There is no abuse and diversion potential with naltrexone.
Patients should not take naltrexone if they:
Currently use or have a physical dependence on opioid-containing medicines or opioid drugs, such as heroin, or currently experiencing opioid withdrawal symptoms
Experience opioid withdrawal symptoms. Withdrawal symptoms may happen when a patient was taking opioid-containing medicines or opioid drugs regularly and then stopped.
Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goose bumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
Patients should talk to their practitioner before starting treatment with naltrexone about the following situations:
Current liver problems, use illegal drugs, have hemophilia or other bleeding problems, have kidney problems, or have any other medical conditions
Are pregnant, plan to become pregnant, or are breastfeeding
All medications, prescriptions and non-prescription medicines, vitamins, and herbal supplement
It is important for practitioners to know if patients are currently taking any opioid-containing medicines for pain, cough, colds, or diarrhea
Currently being treated for an OUD or AUD
Are allergic to naltrexone or any of the ingredients or the liquid used to mix the extended-release naltrexone
Naltrexone for opioid use disorder
To reduce the risk of withdrawal symptoms caused by OUD, patients should wait at least 7 days after their last use of short-acting opioids and 10 to 14 days for long-acting opioids, before starting naltrexone.
Patients taking naltrexone should not use any other opioids or illicit drugs; drink alcohol; or take sedatives, tranquilizers, or other drugs. Patients should notify their practitioner about all medications they are currently taking as well as any changes in medications while being treated with naltrexone.
While the oral formulation will also block opioid receptors, only the long acting injectable formulation is FDA approved as a medication for OUD and requires REMS.
Patients on naltrexone, who discontinue use or relapse after a period of abstinence, may have a reduced tolerance to opioids. Therefore, taking the same, or even lower doses of opioids used in the past can cause life-threatening consequences.
Naltrexone for alcohol use disorder
When starting naltrexone for AUD, patients must not be physically dependent on alcohol or other substances. To avoid strong side effects such as nausea and vomiting, practitioners typically wait until after the alcohol detox process before administering naltrexone.
Naltrexone binds to the endorphin receptors in the body, and blocks the effects and feelings of alcohol. Naltrexone reduces alcohol cravings and the amount of alcohol consumed. Once a patient stops drinking, taking naltrexone helps patients maintain their sobriety. Naltrexone treatment lasts for three to four months. Practitioners should continue to monitor patients who are no longer taking naltrexone.
Common side effects may include:
nausea
sleepiness
headache
dizziness
vomiting
decreased appetite
painful joints
muscle cramps
cold symptoms
trouble sleeping
toothache
Serious side effects may include:
Severe reactions at the site of injection
intense pain
tissue death, surgery may be required
swelling, lumps, or area feels hard
scabs, blisters, or open wounds
Liver damage or hepatitis is possible
stomach area pain lasting more than a few days
dark urine
yellowing of the whites of your eyes
tiredness
Serious allergic reactions
Skin rash
swelling of face, eyes, mouth, or tongue
trouble breathing or wheezing
chest pain
feeling dizzy or faint
Pneumonia
Depressed mood
These are not all the side effects of naltrexone. For more information patients should talk to their practitioner or pharmacist. Patients should tell their practitioner about any side effects that are bothersome, or do not go away.
Naltrexone. Substance Abuse and Mental Health Services Administration (SAMSA) [accessed on Jul 06, 2023]
Naltrexone. MedlinePlus/AHFS® Drug Information. [accessed on Oct 29, 2018]
These FAQs provide a summary of the most important information about Naltrexone. If you would like more information or have any questions, talk to your healthcare provider.
Naltrexone Injection
Naltrexone Injection
Also called: Vivitrol®
Vivitrol (naltrexone) is a prescription injectable medicine used to treat alcohol dependence and to prevent relapse to opioid dependence, after opioid detoxification.
Naltrexone Injection
Also called: Vivitrol®
Vivitrol (naltrexone) is a prescription injectable medicine used to treat alcohol dependence and to prevent relapse to opioid dependence, after opioid detoxification.
Vivitrol can cause serious side effects, including:
1. Risk of opioid overdose. You can accidentally overdose in two ways.
Vivitrol blocks the effects of opioids, such as heroin or opioid pain medicines. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of Vivitrol. This can lead to serious injury, coma, or death.
After you receive a dose of Vivitrol, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with Vivitrol can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
after you have gone through detoxification
when your next Vivitrol dose is due
if you miss a dose of Vivitrol
after you stop Vivitrol treatment
It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
You or someone close to you should get emergency medical help right away if you:
have trouble breathing
become very drowsy with slowed breathing
have slow, shallow breathing (little chest movement with breathing)
feel faint, very dizzy, confused, or have unusual symptoms
2. Severe reactions at the site of the injection (injection site reactions). Some people on Vivitrol have had severe injection site reactions, including tissue death (necrosis). Some of these injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at any of your injection sites:
Intense pain
The area feels hard
Large area of swelling
Lumps
Blisters
An open wound
A dark scab
Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.
3. Sudden opioid withdrawal. Anyone who receives a Vivitrol injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting Vivitrol. Using opioids in the 7 to 14 days before you start receiving Vivitrol may cause you to suddenly have symptoms of opioid withdrawal when you get the Vivitrol injection. Sudden opioid withdrawal can be severe and you may need to go to the hospital.
You must be opioid-free before receiving Vivitrol unless your healthcare provider decides that you don't need to go through detox first. Instead, your doctor may decide to give your Vivitrol injection in a medical facility that can treat you for sudden opioid withdrawal.
4. Liver damage or hepatitis. Naltrexone, the active ingredient in Vivitrol, can cause liver damage or hepatitis. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with Vivitrol:
Stomach area pain lasting more than a few days
Dark urine
Yellowing of the whites of your eyes
Tiredness
Your healthcare provider may need to stop treating you with Vivitrol if you get signs or symptoms of a serious liver problem.
Vivitrol is a prescription injectable medicine used to:
treat alcohol dependence. You should stop drinking before starting Vivitrol.
prevent relapse to opioid dependence, after opioid detoxification. This means that if you take opioids or opioid-containing medicines, you must stop taking them before you start receiving Vivitrol. See “What is the most important information I should know about Vivitrol?”
To be effective, treatment with Vivitrol must be used with other alcohol or drug recovery programs such as counselling. Vivitrol may not work for everyone.
It is not known if Vivitrol is safe and effective in children.
Do not receive Vivitrol if you:
are using or have a physical dependence on opioid-containing medicines or opioid street drugs. See “What is the most important information I should know about Vivitrol?”
To see whether you have a physical dependence on opioid-containing medicines or opioid street drugs, your healthcare provider may give you a small injection of a medicine called naloxone. This is called a naloxone challenge test. If you get symptoms of opioid withdrawal after the naloxone challenge test, do not start treatment with Vivitrol at that time. Your healthcare provider may repeat the test after you have stopped using opioids to see whether it is safe to start Vivitrol.
are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include:
anxiety
sleeplessness
yawning
fever
sweating
teary eyes
runny nose
goose bumps
shakiness
hot or cold flushes
muscle aches
muscle twitches
restlessness
nausea and vomiting
diarrhea
stomach cramps.
See “What is the most important information I should know about Vivitrol?” Tell your healthcare provider if you have any of these symptoms before taking Vivitrol.
are allergic to naltrexone or any of the ingredients in Vivitrol or the liquid used to mix Vivitrol (diluent).
Before you receive Vivitrol, tell your healthcare provider if you:
Have liver problems
Use or abuse street (illegal) drugs
Have hemophilia or other bleeding problems
Have kidney problems
Have any other medical conditions
Are pregnant or plan to become pregnant. It is not known if Vivitrol will harm your unborn baby.
Are breastfeeding. It is not known if Vivitrol passes into your milk, and if it can harm your baby. Naltrexone, the active ingredient in Vivitrol, is the same active ingredient in tablets taken by mouth that contain naltrexone. Naltrexone from tablets passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take Vivitrol. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea. See “What is the most important information I should know about Vivitrol?”
If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or opioid street drugs, it is important that you tell your healthcare provider before starting Vivitrol to avoid having sudden opioid withdrawal symptoms when you start Vivitrol treatment.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Vivitrol is injected by a healthcare provider, about 1 time each month.
Vivitrol is given as an injection into a muscle in your buttocks using a special needle that comes with Vivitrol.
After Vivitrol is injected, it lasts for a month and it cannot be removed from the body.
If you miss your appointment for your Vivitrol injection, schedule another appointment as soon as possible. See “What is the most important information I should know about Vivitrol?”
Whenever you need medical treatment, be sure to tell the treating healthcare provider that you are receiving Vivitrol injections and mention when you got your last dose. This is important because Vivitrol can also block the effects of opioid-containing medicines that might be prescribed for you for pain, cough or colds, or diarrhea.
Carry written information with you at all times to alert healthcare providers that you are taking Vivitrol, so that they can treat you properly in an emergency. Ask your healthcare provider how you can get a wallet card to carry with you.
Do not drive a car, operate machinery, or do other dangerous activities until you know how Vivitrol affects you. Vivitrol may make you feel dizzy and sleepy. See “What are the possible side effects of Vivitrol?”
Vivitrol can cause serious side effects, including:
See “What is the most important information I should know about Vivitrol?”
Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking Vivitrol. You, a family member, or the people closest to you should call your healthcare provider right away if you become depressed or have any of the following symptoms of depression, especially if they are new, worse, or worry you:
You feel sad or have crying spells.
You are no longer interested in seeing your friends or doing things you used to enjoy.
You are sleeping a lot more or a lot less than usual.
You feel hopeless or helpless.
You are more irritable, angry, or aggressive than usual.
You are more or less hungry than usual or notice a big change in your body weight.
You have trouble paying attention.
You feel tired or sleepy all the time.
You have thoughts about hurting yourself or ending your life.
Pneumonia. Some people receiving Vivitrol treatment have had a certain type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital. Tell your healthcare provider right away if you have any of these symptoms during treatment with Vivitrol:
Shortness of breath or wheezing
Coughing that does not go away
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of Vivitrol. Tell your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction.
Skin rash
Swelling of your face, eyes, mouth, or tongue
Trouble breathing or wheezing
Chest pain
Feeling dizzy or faint
Common side effects of Vivitrol may include:
nausea. Nausea may happen after your first Vivitrol injection and usually improves within a few days. Nausea is less likely with future injections of Vivitrol.
sleepiness
headache
dizziness
vomiting
decreased appetite
painful joints
muscle cramps
cold symptoms
trouble sleeping
toothache
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the side effects of Vivitrol. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
VIVITROL - naltrexone Alkermes, Inc.. Medication Guide. [accessed on Oct 25, 2018]
Naltrexone Injection. MedlinePlus/AHFS® Drug Information. [accessed on Oct 29, 2018]
Naltrexone for extended-release injectable suspension (marketed as Vivitrol) Information. FDA Drug Safety and Availability. [accessed on Jul 23, 2015]
These FAQs provide a summary of the most important information about Naltrexone Injection. If you would like more information or have any questions, talk to your healthcare provider.
Buprenorphine and Naloxone
Buprenorphine and Naloxone
Also called: Bunavail®, Suboxone®, Zubsolv®
Buprenorphine and naloxone are a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
Buprenorphine and Naloxone
Also called: Bunavail®, Suboxone®, Zubsolv®
Buprenorphine and naloxone are a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
Buprenorphine and naloxone can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
You feel faint, dizzy, or confused
Your breathing gets much slower than is normal for you
These can be signs of an overdose or other serious problems.
Buprenorphine and naloxone contain an opioid that can cause physical dependence.
Do not stop taking buprenorphine and naloxone without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine
Physical dependence is not the same as drug addiction
Buprenorphine and naloxone are not for occasional or “as needed” use
Feel sleepy and uncoordinated
Have blurred vision
Have slurred speech
Cannot think well or clearly
Have slowed reflexes and breathing
Injecting buprenorphine and naloxone may cause life-threatening infections and other serious health problems.
Injecting buprenorphine and naloxone may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Do not switch from buprenorphine and naloxone to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone may not be the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine and naloxone that may be different than other buprenorphine-containing medicines you may have been taking.
An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using buprenorphine and naloxone. Ask your doctor what you should do if you are taking one of these.
Call a doctor or get emergency help right away if you:
Do not inject (“shoot-up”) buprenorphine and naloxone.
In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone.
Buprenorphine and naloxone are a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy. Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product.
Buprenorphine and naloxone are a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your buprenorphine and naloxone in a safe place to protect them from theft. Never give your buprenorphine and naloxone to anyone else; they can cause death or harm them. Selling or giving away this medicine is against the law.
It is not known if buprenorphine and naloxone are safe or effective in children.
Do not take buprenorphine and naloxone if you are allergic to buprenorphine or naloxone.
Buprenorphine and naloxone may not be right for you. Before taking buprenorphine and naloxone, tell your doctor if you:
Have liver or kidney problems
Have trouble breathing or lung problems
Have an enlarged prostate gland (men)
Have a head injury or brain problem
Have problems urinating
Have a curve in your spine that affects your breathing
Have gallbladder problems
Have adrenal gland problems
Have Addison’s disease
Have low thyroid (hypothyroidism)
Have a history of alcoholism
Have mental problems such as hallucinations (seeing or hearing things that are not there)
Have any other medical condition
Are pregnant or plan to become pregnant. If you take buprenorphine and naloxone while pregnant, your baby may have symptoms of opioid withdrawal or respiratory depression at birth. Talk to your doctor if you are pregnant or plan to become pregnant.
Are breastfeeding or plan to breastfeed. Buprenorphine HCl and naloxone HCl can pass into your milk and may harm the baby. Talk to your doctor about the best way to feed your baby if you take buprenorphine and naloxone. Breastfeeding is not recommended while taking buprenorphine and naloxone.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Buprenorphine and naloxone may affect the way other medicines work and other medicines may affect how buprenorphine and naloxone work. Some medicines may cause serious or life-threatening medical problems when taken with buprenorphine and naloxone.
Sometimes the doses of certain medicines and buprenorphine and naloxone may need to be changed if used together. Do not take any medicine while using buprenorphine and naloxone until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are using buprenorphine and naloxone.
Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.
Take buprenorphine and naloxone according to your health care provider’s instructions. Your health care provider will tell you how much buprenorphine and naloxone to take and when to take it. Before you start buprenorphine and naloxone and each time you get a refill, read any printed information that comes with your medicine.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take buprenorphine and naloxone.
You should not drink alcohol while using buprenorphine and naloxone, as this can lead to loss of consciousness or even death.
Buprenorphine and naloxone can cause serious side effects including:
See “What is the most important information I should know about buprenorphine and naloxone?”
Respiratory problems. You have a higher risk of death and coma if you take buprenorphine and naloxone with other medicines, such as benzodiazepines.
Sleepiness, dizziness, and problems with coordination
Dependency or abuse
Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take buprenorphine and naloxone.
Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches. Tell your doctor if you develop any of these symptoms.
Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
Common side effects of buprenorphine and naloxone include:
Nausea
Vomiting
Drug withdrawal syndrome
Headache
Sweating
Numb mouth
Constipation
Swollen and/or painful tongue
The inside of your mouth is more red than normal
Intoxication (feeling lightheaded or drunk)
Disturbance in attention
Irregular heartbeat (palpitations)
Decrease in sleep (insomnia)
Blurred vision
Back pain
Fainting
Dizziness
Sleepiness
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects of buprenorphine and naloxone. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects.
Store buprenorphine and naloxone at room temperature between 68°F and 77°F (20°C to 25°C).
Keep buprenorphine and naloxone in a safe place, out of the sight and reach of children.
Dispose of unused buprenorphine and naloxone sublingual tablets as soon as you no longer need them.
Unused tablets should be flushed down the toilet.
Dispose of unused buprenorphine and naloxone sublingual films as soon as you no longer need them.
Unused films should be removed from the foil pouch and flushed down the toilet.
Do not flush the buprenorphine and naloxone sublingual film foil pouch down the toilet.
BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone tablet REMEDYREPACK INC.. Medication Guide. [accessed on Oct 24, 2018]
BUNAVAIL- buprenorphine and naloxone film BioDelivery Sciences International, Inc.. Medication Guide. [accessed on Oct 24, 2018]
SUBOXONE- buprenorphine hydrochloride, naloxone hydrochloride film, soluble Aidarex Pharmaceuticals LLC. Medication Guide. [accessed on Oct 26, 2018]
ZUBSOLV- buprenorphine hydrochloride and naloxone hydrochloride tablet, orally disintegrating Orexo US, Inc.. Medication Guide. [accessed on Oct 24, 2018]
These FAQs provide a summary of the most important information about Buprenorphine and Naloxone. If you would like more information or have any questions, talk to your healthcare provider.
Additional Materials (1)
Buprenorphine implants; A new implant treatment for addicts
Video by CBS Evening News/YouTube
2:08
Buprenorphine implants; A new implant treatment for addicts
CBS Evening News/YouTube
Buprenorphine Extended-Release Injection
Buprenorphine Extended-Release Injection
Also called: Sublocade™
Sublocade (buprenorphine extended-release) is a once-monthly injectable medicine for the treatment of moderate-to-severe opioid use disorder (OUD) in certain adults.
Buprenorphine Extended-Release Injection
Also called: Sublocade™
Sublocade (buprenorphine extended-release) is a once-monthly injectable medicine for the treatment of moderate-to-severe opioid use disorder (OUD) in certain adults.
Because of the serious risk of potential harm or death from self-injecting Sublocade into a vein (intravenously), it is only available through a restricted program called the Sublocade REMS Program.
Sublocade is not available in retail pharmacies.
Your Sublocade injection will only be given to you by a certified healthcare provider.
In an emergency, you or your family should tell the emergency medical staff that you are physically dependent on an opioid and are being treated with Sublocade.
Buprenorphine, the medicine in Sublocade, can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:
feel faint or dizzy
have mental changes such as confusion
have slower breathing than you normally have
have severe sleepiness
have blurred vision
have problems with coordination
have slurred speech
cannot think well or clearly
have a high body temperature
have slowed reflexes
feel agitated
have stiff muscles
have trouble walking
These can be signs of an overdose or other serious problems.
Death or serious harm can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, muscle relaxants, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with Sublocade. Tell your healthcare provider if you are taking any of these medicines and if you drink alcohol.
Sublocade is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who:
have received treatment with an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine for 7 days and
are taking a dose that controls withdrawal symptoms for at least seven days.
Sublocade is part of a complete treatment plan that should include counseling.
It is not known if Sublocade is safe or effective in children.
Sublocade is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs.
Do not use Sublocade if you are allergic to buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® Delivery System).
Sublocade may not be right for you. Before starting Sublocade, tell your healthcare provider about all of your medical conditions, including:
Trouble breathing or lung problems
An enlarged prostate gland (men)
A head injury or brain problem
Problems urinating
A curve in your spine that affects your breathing (scoliosis)
Liver problems
Gallbladder problems
Adrenal gland problems
Addison's disease
Low thyroid hormone levels (hypothyroidism)
A history of alcoholism
Mental problems such as hallucinations (seeing or hearing things that are not there).
Are pregnant or plan to become pregnant. If you receive Sublocade while pregnant, your baby may have symptoms of opioid withdrawal at birth.
Are breastfeeding or plan to breastfeed. Sublocade can pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with Sublocade. Watch your baby for increased drowsiness and breathing problems.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Sublocade may affect the way other medicines work and other medicines may affect how Sublocade works. Some medicines may cause serious or life-threatening medical problems when taken with Sublocade.
The doses of certain medicines may need to be changed if used during treatment with Sublocade. Do not take any medicine during treatment with Sublocade until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines during treatment with Sublocade.
You should not take anxiety medicines or benzodiazepines (such as Valium® or Xanax®), sleeping pills, tranquilizers, muscle relaxants, or sedatives (such as Ambien®), antidepressants, or antihistamines that are not prescribed to you during treatment with Sublocade, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death. If a healthcare provider is considering prescribing such a medicine for you, remind the healthcare provider that you are being treated with Sublocade.
You may have detectable levels of Sublocade in your body for a long period after stopping treatment with Sublocade.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
You will receive Sublocade by your healthcare provider as an injection just under the skin (subcutaneous) of your stomach (abdomen). You will receive Sublocade monthly (with at least 26 days between doses).
Sublocade is injected as a liquid. After the injection, Sublocade changes to a solid form called a depot. The depot may be seen or felt as a small bump under your skin at the injection site on your abdomen for several weeks. The depot will get smaller over time.
Do not try to remove the depot.
Do not rub or massage the injection site.
Try not to let belts or clothing waistbands rub against the injection site.
If you miss a dose of Sublocade, see your healthcare provider to get your Sublocade injection as soon as possible.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medicine affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few days after your injection and when your dose is changed.
Do not drink alcohol during treatment with Sublocade, as this can lead to slowed breathing, drowsiness, slow reaction time, loss of consciousness or even death.
Sublocade can cause serious side effects, including: See “What is the most important information I should know about Sublocade?”
Physical dependence and withdrawal. Your body can develop a physical need for Sublocade (dependence). If you stop receiving Sublocade, you could have opioid withdrawal symptoms such as:
shaking, goose bumps, muscle aches
sweating more than normal
feeling hot or cold more than normal
runny nose and watery eyes
diarrhea or vomiting
These symptoms may start weeks to months after your last dose of Sublocade.
Liver problems. Call your healthcare provider right away if you notice any of these signs of liver problems:
your skin or the white part of your eyes turns yellow (jaundice)
urine turns dark
bowel movements (stools) turn light in color
decreased appetite
stomach (abdomen) pain or nausea
Your healthcare provider may do tests before and during treatment with Sublocade to check your liver.
Allergic reaction. Call your healthcare provider or get emergency help right away if you get:
ash, hives, itching
swelling of your face
wheezing
dizziness, or a decrease in consciousness
Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.
The most common side effects of Sublocade include:
constipation
headache
nausea
injection site itching
vomiting
increase in liver enzymes
tiredness
injection site pain
Long-term (chronic) use of opioids, including Sublocade, may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of Sublocade. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
SUBLOCADE (buprenorphine) solution [accessed on Feb 07, 2019]
Buprenorphine Injection. MedlinePlus/AHFS® Drug Information. [accessed on Oct 29, 2018]
FDA NEWS RELEASE: FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder [accessed on Dec 04, 2017]
These FAQs provide a summary of the most important information about Buprenorphine Extended-release Injection. If you would like more information or have any questions, talk to your healthcare provider.
Buprenorphine Transdermal Patch
Buprenorphine Transdermal Patch
Also called: BuTrans®
Buprenorphine transdermal patch is a narcotic used to treat severe around-the-clock pain when other pain treatments are not effective. It must be used with caution due to the risks of opioid addiction, abuse, and misuse.
Buprenorphine Transdermal Patch
Also called: BuTrans®
Buprenorphine transdermal patch is a narcotic used to treat severe around-the-clock pain when other pain treatments are not effective. It must be used with caution due to the risks of opioid addiction, abuse, and misuse.
Get emergency help right away if you take too much buprenorphine transdermal patch (overdose). When you first start taking buprenorphine transdermal patch, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking buprenorphine transdermal patch with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your buprenorphine transdermal patch. They could die from taking it. Store buprenorphine transdermal patch away from children and in a safe place to prevent stealing or abuse. Selling or giving away buprenorphine transdermal patch is against the law.
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Not for use to treat pain that is not around-the-clock.
Do not use buprenorphine transdermal patch if you have:
Severe asthma, trouble breathing, or other lung problems.
A bowel blockage or have narrowing of the stomach or intestines.
Before you apply buprenorphine transdermal patch, tell your healthcare provider if you have:
head injury, seizures
problems urinating
heart rhythm problems (Long QT syndrome)
liver, kidney, thyroid problems
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems
Tell your healthcare provider if you:
Have a fever.
Are pregnant or planning to become pregnant. Prolonged use of buprenorphine transdermal patch during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Are breastfeeding. Not recommended during treatment with buprenorphine transdermal patch. It may harm your baby.
Are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking buprenorphine transdermal patch with certain other medicines can cause serious side effects.
Do not change your dose. Apply buprenorphine transdermal patch exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
See the detailed Instructions for Use for information about how to apply the buprenorphine transdermal patch.
Do not apply a buprenorphine transdermal patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
You should wear 1 buprenorphine transdermal patch continuously for 7 days.
Call your healthcare provider if the dose you are using does not control your pain.
Do not stop using buprenorphine transdermal without talking to your healthcare provider.
To properly dispose of used and unused patches, use the Patch-Disposal Unit or fold in half and flush down the toilet. See the detailed Instructions for Use.
Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps. These can cause an overdose that can lead to death.
Drive or operate heavy machinery, until you know how buprenorphine transdermal patch affects you. Buprenorphine transdermal patch can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with buprenorphine transdermal patch may cause you to overdose and die.
Possible side effects include:
constipation
nausea
sleepiness
vomiting
tiredness
headache
dizziness
itching, redness or rash where the patch is applied
Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
trouble breathing
shortness of breath
fast heartbeat
chest pain
swelling of your face, tongue or throat
extreme drowsiness
light-headedness when changing positions
feeling faint
agitation
high body temperature
trouble walking
stiff muscles
mental changes such as confusion.
These are not all the possible side effects of buprenorphine transdermal patch. Call your doctor for medical advice about side effects.
BUPRENORPHINE- buprenorphine patch Lake Erie Medical DBA Quality Care Products LLC. Medication Guide. [accessed on Oct 24, 2018]
BUTRANS- buprenorphine patch, extended release Purdue Pharma LP. Medication Guide. [accessed on Oct 24, 2018]
Buprenorphine Transdermal Patch. MedlinePlus/AHFS® Drug Information. [accessed on Oct 29, 2018]
These FAQs provide a summary of the most important information about Buprenorphine Transdermal Patch. If you would like more information or have any questions, talk to your healthcare provider.
Naltrexone Implant
Naltrexone Implant
Naltrexone implants are used for the treatment of alcohol or opioid dependence. Treatment with naltrexone implants should be part of a comprehensive management program that includes psychological and psychosocial support.
Naltrexone Implant
Naltrexone implants are used for the treatment of alcohol or opioid dependence. Treatment with naltrexone implants should be part of a comprehensive management program that includes psychological and psychosocial support.
Do not use narcotic drugs or alcohol while you are being treated with naltrexone implants. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain during your treatment with naltrexone injection. These medicines may contain narcotics or alcohol.
Use of Naltrexone Implants does not eliminate or diminish substance abuse withdrawal symptoms.
Naltrexone implants may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
You may notice pain, redness, bruising, swelling, or a hard lump where the medication was implanted. Call your doctor if you have this type of reaction to the implant, especially if it does not clear up or gets worse within 2 weeks.
Wear a medical alert tag or carry an ID card stating that you use naltrexone implants. Any medical care provider who treats you should know that you are receiving this medication.
Alert your healthcare professional right away if you develop serious bouts of depression or suicidal thinking.
Families and caregivers of patients being treated with Naltrexone Implants should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient’s healthcare professional.
Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone implants.
You may be more sensitive to lower doses of opioids after Naltrexone Implant treatment is discontinued. Reduced tolerance is especially of concern at the end of a dosing interval, that is, near the end of the dosing cycle after the Naltrexone Implant was administered, or after a dose of Naltrexone Implant is missed. It is also important that you inform family members and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Naltrexone blocks the effects of narcotic medicines and alcohol. Naltrexone implants are used to treat addiction to alcohol or narcotic drugs. It is also used to prevent narcotic addiction relapse. Naltrexone implants prevents the reward effects of opioids and alcohol with subsequent use.
Craving decrease substantially in those people on naltrexone, and that this craving reduction occurs very quickly, from the beginning of treatment (first 2-3 weeks) and doesn’t seem to return after that. There are certainly people who continue to have cravings, but this is a rather small proportion and usually occurs only after coming off medication. Those who maintain treatment with naltrexone have no cravings, and some believe that combining naltrexone with personal recovery work in a 12-step based program is especially effective.
Naltrexone implants may also be used for purposes not listed here.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Blurred vision or eye problems
Fast heartbeat
Wheezing, difficulty breathing
Mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself
Nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
Ear pain, ringing in your ears
Feeling light-headed, fainting
Skin rash or itching
Pain, redness, bruising, itching, swelling, oozing, skin changes, or a hard lump where the medication was implanted
Less serious side effects may include:
Feeling anxious, nervous, restless, or irritable
Increased thirst
Muscle or joint aches
Weakness or tiredness
Sleep problems (insomnia)
Decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Do not receive this implant if you are allergic to naltrexone, polyvinylpyrrolidone, stearic acid, ascorbic acid, triamcinolone or if you have:
A history of alcohol or narcotic drug use within the past 7-10 days; or
Drug or alcohol withdrawal symptoms.
To make sure you can safely use naltrexone implant, tell your doctor if you have any of these other conditions:
Kidney disease
Liver disease
A bleeding disorder such as hemophilia
FDA pregnancy category C. It is not known whether naltrexone implant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether naltrexone implant passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Naltrexone implants are placed under the skin. The implants are usually given once every 3 months (every 10-12 weeks) and can be given only by a doctor in a clinic.
It is important to receive your naltrexone implants regularly to get the most benefit.
Avoid bath tubs and hot tubs, swimming or exercise for 7 days after implantation to minimize risk of the implant coming out.
You may notice pain, redness, bruising, swelling, or a hard lump where the medication was implanted. Call your doctor if you have this type of reaction to the implant, especially if it does not clear up or gets worse within 2 weeks.
Wear a medical alert tag or carry an ID card stating that you use naltrexone implants. Any medical care provider who treats you should know that you are receiving this medication.
Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone injection.
Call your doctor for instructions if you miss an appointment to receive your naltrexone implant.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, stomach pain, dizziness, or seizure (convulsions).
Naltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Do not use narcotic drugs or alcohol while receiving naltrexone implants. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while you are being treated with naltrexone implants. These medicines may contain narcotics or alcohol.
The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with naltrexone implants. Harmful side effects could also occur.
Tell your doctor about all other medicines you use, especially:
Buprenorphine (Buprenex, Subutex)
Butorphanol (Stadol)
Codeine (Tylenol with Codeine)
Hydrocodone (Lortab, Vicodin)
Hydromorphone (Dilaudid)
Levorphanol (Levo-Dromoran)
Meperidine (Demerol)
Methadone (Dolophine, Methadose)
Morphine (Kadian, MS Contin, Roxanol)
Nalbuphine (Nubain)
Naloxone (Narcan)
Oxycodone (Oxycontin, Roxicodone, Percocet)
Oxymorphone (Numorphan)
Propoxyphene (Darvon, Darvocet)
This list is not complete and other drugs may interact with naltrexone implants. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Your doctor can provide more information about naltrexone implants.
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
LABEL: NALTREXONE- naltrexone implant [accessed on Jan 15, 2019]
These FAQs provide a summary of the most important information about Naltrexone Implant. If you would like more information or have any questions, talk to your healthcare provider.
How Does It Work?
Naloxone 3
Image by Intropin (Mark Oniffrey)/Wikimedia
Naloxone 3
Naloxone preparation, single dose pre-filled syringe for intravenous administration.
Image by Intropin (Mark Oniffrey)/Wikimedia
How Do Medications to Treat Opioid Use Disorder Work?
Opioid Agonists and Partial Agonists (Maintenance Medications)
Studies show that people with opioid use disorder who follow detoxification with complete abstinence are very likely to relapse, or return to using the drug. While relapse is a normal step on the path to recovery, it can also be life threatening, raising the risk for a fatal overdose.11 Thus, an important way to support recovery from heroin or prescription opioid use disorder is to maintain abstinence from those drugs. Someone in recovery can also use medications that reduce the negative effects of withdrawal and cravings without producing the euphoria that the original drug of abuse caused. For example, the FDA recently approved lofexidine, a non-opioid medicine designed to reduce opioid withdrawal symptoms. Methadone and buprenorphine are other medications approved for this purpose.
Methadone is a synthetic opioid agonist that eliminates withdrawal symptoms and relieves drug cravings by acting on opioid receptors in the brain—the same receptors that other opioids such as heroin, morphine, and opioid pain medications activate. Although it occupies and activates these opioid receptors, it does so more slowly than other opioids and, in an opioid-dependent person, treatment doses do not produce euphoria. It has been used successfully for more than 40 years to treat opioid use disorder and must be dispensed through specialized opioid treatment programs.
Buprenorphine is a partial opioid agonist, meaning that it binds to those same opioid receptors but activates them less strongly than full agonists do. Like methadone, it can reduce cravings and withdrawal symptoms in a person with an opioid use disorder without producing euphoria, and patients tend to tolerate it well. Research has found buprenorphine to be similarly effective as methadone for treating opioid use disorders, as long as it is given at a sufficient dose and for sufficient duration. The U.S. Food and Drug Administration (FDA) approved buprenorphine in 2002, making it the first medication eligible to be prescribed by certified physicians through the Drug Addiction Treatment Act. This approval eliminates the need to visit specialized treatment clinics, thereby expanding access to treatment for many who need it. Additionally, the Comprehensive Addiction and Recovery Act (CARA), which was signed into law in July 2016, temporarily expands eligibility to prescribe buprenorphine-based drugs for medication-assisted treatment (MAT) to qualifying nurse practitioners and physician assistants through October 1, 2021. Buprenorphine has been available for opioid use disorders since 2002 as a tablet and since 2010 as a sublingual film. The FDA approved a 6-month subdermal buprenorphine implant in May 2016 and a once-monthly buprenorphine injection in November 2017. These formulations are available to patients stabilized on buprenorphine and will eliminate the treatment barrier of daily dosing for these patients. (Also see "What are misconceptions about maintenance treatment?")
Opioid Antagonists
Naltrexone is an opioid antagonist, which means that it works by blocking the activation of opioid receptors. Instead of controlling withdrawal and cravings, it treats opioid use disorder by preventing any opioid drug from producing rewarding effects such as euphoria. Its use for ongoing opioid use disorder treatment has been somewhat limited because of poor adherence and tolerability by patients. However, in 2010, an injectable, long-acting form of naltrexone (Vivitrol), originally approved for treating alcohol use disorder, was FDA-approved for treating opioid use disorder. Because its effects last for weeks, Vivitrol is a good option for patients who do not have ready access to health care or who struggle with taking their medications regularly.
Because each medication works differently, a treatment provider should decide on the optimal medication in consultation with the individual patient and should consider the patient’s unique history and circumstances.
Source: National Institute on Drug Abuse (NIDA)
Is It Effective?
Methadone is used in Australian-supported programs
Image by Photo by: Josh Estey Department of Foreign Affairs and Trade/Wikimedia
Methadone is used in Australian-supported programs
Methadone is used in Australian-supported programs in Indonesia to stop drug users from injecting drugs with needles to reduce the spread of HIV.
Photo by: Josh Estey for AusAID.
Contact photolibrary@ausaid.gov.au to request a high resolution original.
Image by Photo by: Josh Estey Department of Foreign Affairs and Trade/Wikimedia
How Effective Are Medications to Treat Opioid Use Disorder?
Abundant evidence shows that methadone, buprenorphine, and naltrexone all reduce opioid use and opioid use disorder-related symptoms, and they reduce the risk of infectious disease transmission as well as criminal behavior associated with drug use. These medications also increase the likelihood that a person will remain in treatment, which itself is associated with lower risk of overdose mortality, reduced risk of HIV and HCV transmission, reduced criminal justice involvement, and greater likelihood of employment.
Methadone
Methadone is the medication with the longest history of use for opioid use disorder treatment, having been used since 1947. A large number of studies (some of which are summarized in the graph below) support methadone's effectiveness at reducing opioid use. A comprehensive Cochrane review in 2009 compared methadone-based treatment (methadone plus psychosocial treatment) to placebo with psychosocial treatment and found that methadone treatment was effective in reducing opioid use, opioid use-associated transmission of infectious disease, and crime. Patients on methadone had 33 percent fewer opioid-positive drug tests and were 4.44 times more likely to stay in treatment compared to controls. Methadone treatment significantly improves outcomes, even when provided in the absence of regular counseling services; long-term (beyond 6 months) outcomes are better in groups receiving methadone, regardless of the frequency of counseling received.
Buprenorphine
Buprenorphine, which was first approved in 2002, is currently available in two forms: alone (Probuphine, Sublocade™, Bunavail) and in combination with the opioid receptor antagonist naloxone (Suboxone, Zubsolv). Both formulations of buprenorphine are effective for the treatment of opioid use disorders, though some studies have shown high relapse rates among patients tapered off of buprenorphine compared to patients maintained on the drug for a longer period of time.
A Swedish study compared patients maintained on 16 mg of buprenorphine daily to a control group that received buprenorphine for detoxification (6 days) followed by placebo. All patients received psychosocial supports. In this study, the treatment failure rate for placebo was 100 percent vs. 25 percent for buprenorphine. More than two opioid-positive urine tests within 3 months resulted in cessation of treatment, so treatment retention was closely related to relapse. Of patients not retained in treatment, there was a 20 percent mortality rate.
Meta-analysis determined that patients on doses of buprenorphine of 16 mg per day or more were 1.82 times more likely to stay in treatment than placebo-treated patients, and buprenorphine decreased the number of opioid-positive drug tests by 14.2 percent (the standardized mean difference was -1.17).
To be effective, buprenorphine must be given at a sufficiently high dose (generally, 16 mg per day or more). Some treatment providers wary of using opioids have prescribed lower doses for short treatment durations, leading to failure of buprenorphine treatment and the mistaken conclusion that the medication is ineffective.
Methadone and Buprenorphine Compared
Methadone and buprenorphine are equally effective at reducing opioid use. A comprehensive Cochrane review comparing buprenorphine, methadone, and placebo found no differences in opioid-positive drug tests or self-reported heroin use when treating with methadone or buprenorphine at medium-to-high doses.
Notably, flexible dose regimens of buprenorphine and doses of buprenorphine of 6 mg or below are less effective than methadone at keeping patients in treatment, highlighting the need for delivery of evidence-based dosing regimens of these medications.
Naltrexone
Naltrexone was initially approved for the treatment of opioid use disorder in a daily pill form. It does not produce tolerance or withdrawal. Poor treatment adherence has primarily limited the real-world effectiveness of this formulation. As a result, there is insufficient evidence that oral naltrexone is an effective treatment for opioid use disorder. Extended-release injectable naltrexone (XR-NTX) is administered once monthly, which removes the need for daily dosing. While this formulation is the newest form of medication for opioid use disorder, evidence to date suggests that it is effective.
The double-blind, placebo-controlled trial that was most influential in getting XR-NTX approved by the FDA in 2010 for opioid use disorder treatment showed that XR-NTX significantly increased opioid abstinence. The XR-NTX group had 90 percent confirmed abstinent weeks compared to 35 percent in the placebo group. Treatment retention was also higher in the XR-NTX group (58 percent vs. 42 percent), while subjective drug craving and relapse were both decreased (0.8 percent vs. 13.7 percent). Improvement in the XR-NTX group was sustained throughout an open label period out to 76 weeks. These data were collected in Russia, and additional studies are required to determine if effectiveness will be similar in the United States.
Buprenorphine and Naltrexone Compared
A NIDA study showed that once treatment is initiated, a buprenorphine/naloxone combination and an extended release naltrexone formulation are similarly effective in treating opioid use disorder. Because naltrexone requires full detoxification, initiating treatment among active opioid users was more difficult with this medication. However, once detoxification was complete, the naltrexone formulation had a similar effectiveness as the buprenorphine/naloxone combination.
Source: How effective are medications to treat opioid use disorder? | National Institute on Drug Abuse (NIDA)
Additional Materials (3)
Methadone synthesis
Synthesis of methadone - according to US Patent # 4242274 (Taylor, 1980) -- URL: http://www.google.com/patents?tbs=bks%3A1&tbo=1&q=4242274&btnG=Search+Patents
Image by Jtjdp/Wikimedia
Methadone synthesis
Jtjdp/Wikimedia
Common Misconceptions
Severe contact dermatitis buprenorphine transdermal patch
Image by Dr.khatmando/Wikimedia
Severe contact dermatitis buprenorphine transdermal patch
ブプレノルフィン(ノルスパンテープ)パッチの副作用。15mcg/h,3日目の時点で副作用発生。
Image by Dr.khatmando/Wikimedia
What Are Misconceptions About Maintenance Treatment?
Because maintenance medications (methadone and buprenorphine) are themselves opioids and are able to produce euphoria in people who are not dependent on opioids, many people have assumed that this form of treatment just substitutes a new substance use disorder for an old one. This belief has unfortunately hindered the adoption of these effective treatments. In the past, even some inpatient treatment programs that were otherwise evidence-based did not allow patients to use these medications, in favor of an "abstinence only" philosophy.
Although it is possible for individuals who do not have an opioid use disorder to get high on buprenorphine or methadone (see "What is the treatment need versus the diversion risk for opioid use disorder treatment?"), these medications affect people who have developed a high tolerance (see "Opioid Tolerance") to opioids differently. At the doses prescribed, and as a result of their pharmacodynamic and pharmacokinetic properties (the way they act at opioid receptor sites and their slower metabolism in the body), these medications do not produce a euphoric high but instead minimize withdrawal symptoms and cravings (see "Mechanisms of Opioid Dependence"). This makes it possible for the patient to function normally, attend school or work, and participate in other forms of treatment or recovery support services to help them become free of their substance use disorder over time.
The ultimate aim can be to wean off the maintenance medication, but the treatment provider should make this decision jointly with the patient and tapering the medication must be done gradually. It may take months or years in some cases. Just as body tissues require prolonged periods to heal after injury and may require external supports (e.g., a cast and crutches or a wheelchair for a broken leg), brain circuits that have been altered by prolonged drug use and substance use disorder take time to recover and benefit from external supports in the form of medication. In cases of serious and long-term opioid use disorder, a patient may need these supports indefinitely.
In 2005, methadone and buprenorphine were added to the World Health Organization's list of essential medicines, defined as medicines that are "intended to be available within the context of functioning health care systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford."
Opioid Tolerance
People who take opioids for long periods of time typically develop tolerance, a state in which more of the drug is needed to produce the same effect. Receptor desensitization and downregulation are molecular processes that cause tolerance. In people with opioid use disorder, the brain is continually exposed to high levels of opioids as well as dopamine, which is released in the reward circuit following opioid receptor activation. Brain cells respond to this by reducing their response to receptor activation and by removing opioid and dopamine receptors from the cell membrane, resulting in fewer receptors that can be activated by the drug. These mechanisms result in a lessened response to the drug, so higher doses are required to elicit the same effect. This opioid tolerance is the reason that people with opioid use disorder do not experience euphoric effects from therapeutic doses of buprenorphine or methadone, while people without opioid use disorder do. It is also the reason why people are at increased risk of overdose when relapsing to opioid use after a period of abstinence: They lose their tolerance to the drug without realizing it, so they no longer know what dose of the drug they can safely tolerate.
Mechanisms of Opioid Dependence
The sustained activation of opioid receptors that results from opioid use disorder and causes tolerance also causes withdrawal symptoms when the opioid drugs leave the body. Drug withdrawal symptoms are opposite to the symptoms caused by drug taking. In the case of opioids, they include anxiety, jitters, and diarrhea. Avoidance of these negative symptoms is one reason that people keep taking opioids, and in the early stages of treatment, medications such as methadone and buprenorphine reduce withdrawal symptoms.
Source: National Institute on Drug Abuse (NIDA)
Treatment Need vs Diversion Risk
Opioid use disorder
Image by Todd Huffman from Phoenix, AZ
Opioid use disorder
The contents of a needle exchange kit.The items are (also annotated in the picture), from the top clockwise: a torniquet, cotton balls, a pot for cooking drugs, a condom, sterile water, alcohol swabs, and (from l-r) a thin needle, a thinner needle, and the thinnest needle.Multiple needles of different bore sizes are included. Reason: The viscosity of drugs can be radically different, i.e. methadone is more viscous than heroin which is more viscous than cocaine. Pushing methadone through a small needle is impossible.
Image by Todd Huffman from Phoenix, AZ
What Is the Treatment Need Versus the Diversion Risk for Opioid Use Disorder Treatment?
Like other opioid medications, buprenorphine and methadone are sometimes diverted and misused. However, most data suggest that the majority of buprenorphine and methadone misuse (use without a prescription) is for the purpose of controlling withdrawal and cravings for other opioids and not to get high. Among all opioid agonist medications, methadone and buprenorphine together make up 15 percent of diversion reports, while oxycodone and hydrocodone are responsible for 67 percent. Naltrexone, an opioid antagonist used to treat opioid addiction, does not cause euphoric effects and is not a diversion risk.
Diversion Risk of Buprenorphine
Both buprenorphine and buprenorphine/naloxone formulations can interfere with the effects of full opioid agonists, such as heroin, and can precipitate withdrawal in individuals with opioid dependence. Two U.S. surveys of people with opioid use disorder found that a majority of those who used illicit buprenorphine reported that they used it for therapeutic purposes (i.e., to reduce withdrawal symptoms, reduce heroin use, etc.). Ninety-seven percent reported using it to prevent cravings, 90 percent to prevent withdrawal, and 29 percent to save money. Illicit use of buprenorphine decreased as individuals had access to treatment. The minority proportion of people who use buprenorphine illicitly to get high (ranging from 8 to 25 percent) has been shown to decrease over time, which could suggest that people abandon this goal after they experience the drug’s blunted rewarding effects. Indeed, patients in treatment for opioid use disorder rarely endorse buprenorphine as the primary drug of misuse.
While there is some risk associated with misuse of buprenorphine, the risk of harms, such as fatal overdose, are significantly lower than those of full agonist opioids (oxycodone, hydrocodone, heroin). Overdoses and related deaths do occur but are usually the result of combination with other respiratory depressant drugs such as benzodiazepines or alcohol. Emergency department (ED) visits involving buprenorphine increased from 3,161 in 2005 to 30,135 visits in 2010 as availability of the drug increased (buprenorphine was first approved in 2002); but ED visits for buprenorphine remain significantly less common than those for other opioids. Fifty-two percent, or 15,778 visits (see left bar chart below), were related to nonmedical use in 2010; 59 percent of these visits involved additional drugs (see right bar chart below).
Source: CBHSQ, 2011
Diversion Risk of Methadone
Methadone diversion is primarily associated with methadone prescribed for the treatment of pain and not for the treatment of opioid use disorders. Opioid treatment programs are required to maintain and implement a diversion control plan; they typically require patients to come in daily to receive their medication and strictly monitor take-home doses. In addition, evidence suggests that the diversion that does occur is associated with a lack of access to medication. In one survey, giving methadone away was identified as the most common form of methadone diversion, which aligns with other findings that 80 percent of people who report diverting methadone did so to help others who misused substances. Among those using illicit methadone, the most common reason was a missed medication pick-up.
Methadone, as a full opioid agonist that is metabolized slowly, poses a greater risk of overdose than buprenorphine. In 2010, 65,945 ED visits involved nonmedical use of methadone. However, methadone that is dispensed for use as a pain reliever, not as an substance use disorder medication, is the main source of the methadone involved in overdose deaths.
Source: National Institute on Drug Abuse (NIDA)
HIV/Hepatitis Risk
HIV in Indonesia
Image by Photo by: Josh Estey - Department of Foreign Affairs and Trade
HIV in Indonesia
Methadone is used in Australian-supported programs in Indonesia to stop drug users from injecting drugs with needles to reduce the spread of HIV.
Image by Photo by: Josh Estey - Department of Foreign Affairs and Trade
What Is the Impact of Medication for Opioid Use Disorder Treatment on HIV/HCV Outcomes?
Injection drug use is still a primary driver of the HIV/AIDS epidemic across the world. A recent example is the small community of Austin, Indiana, where 170 new HIV infections occurred in the 8 months between November 2014 and June 2015 among people misusing the prescription opioid pain reliever oxymorphone (Opana) via injection. People who inject drugs frequently share their needles and other injection equipment, enabling viruses such as HIV and hepatitis C (HCV) to spread between people.
Medications for opioid use disorder treatment can reduce transmission of HIV and HCV by reducing risk behaviors in people who inject drugs and can improve HIV- and HCV-related outcomes by treating those not engaged in injection opioid use who might otherwise transition to injection, linking those with HIV/HCV infection to appropriate treatment, and improving adherence to HIV/HCV treatment. These improvements depend on accessibility of medications for opioid use disorder to people who need it and coordinating medication delivery with HCV/HIV screening and treatment.
Treatment with methadone or buprenorphine is associated with reduced injection drug use risk behaviors. Meta-analyses have shown a reduction in risk behaviors including a 32 to 69 percent reduction in illicit opioid use, a 20 to 60 percent reduction in injection drug use, and a 25 to 86 percent reduction in sharing of injection equipment. Treatment with extended-release naltrexone also reduced HIV risk behaviors compared to placebo.
Methadone and buprenorphine treatment are also associated with lower HCV infection rates in young adults who inject drugs, while other treatments and detoxification alone are not. Methadone treatment is associated with low rates of contracting HCV overall, with mathematical modeling suggesting that it can prevent 22.6 new HCV infections per 100 treated people who engaged in injection drug use, per year. Methadone treatment also reduces both HIV risk behaviors and HIV infection, with better outcomes for people who inject drugs who are in treatment (3.5 percent contracting HIV vs. 22 percent), and better outcomes for longer treatment duration and for continuous (versus interrupted) treatment.
A study comparing the effects of methadone and buprenorphine treatment on HIV risk from injection behaviors and HIV risk from sexual behaviors showed equal and significant reductions in risky injection behaviors. Risky sexual behaviors were reduced in both male and female methadone patients but were higher in male patients on buprenorphine.
Mitigating Factors
There are several known interactions between medications used to treat HIV or HCV and both methadone and buprenorphine. These could require an adjustment of dosage or revision of the treatment plan, and highlight the need for integrated care. For example, some patients are reluctant to begin highly active antiretroviral therapy (HAART) because of worries that it will interfere with their methadone treatment, so treatment providers should consider revised methadone doses for these patients.
Contracting HCV while on methadone is associated with continued injection drug use. Some studies have shown methadone detoxification alone to be associated with increased rates of contracting HIV, so ongoing treatment with this medication is key to reducing transmission of viral infection.
Possibility of Dual Therapeutic Potential
One recent report demonstrates the potential of buprenorphine to counteract a neuroinflammatory process that is involved in HIV-associated neurocognitive disorders, suggesting that buprenorphine could potentially be simultaneously therapeutic for opioid use disorder and HIV. Opioid use disorder medications are also associated with increased adherence to HAART for the treatment of HIV. Some providers hesitate to treat HCV in people who inject drugs, but a naltrexone implantation clinic showed rates of sustained virologic response in their patients that were comparable to clinics treating non-injection-drug-using patients.
Source: National Institute on Drug Abuse (NIDA)
Criminal Justice System
Criminal Justice System Flowchart
Image by U.S. Department of Justice, Office of Justice Programs
Criminal Justice System Flowchart
The diagram illustrates the sequence of events in the criminal justice system.
To link to a text description of each section, return to the Justice System page.
The flowchart of the events in the criminal justice system (shown in the diagram) updates the original chart prepared by the President's Commission on Law Enforcement and the Administration of Justice in 1967. The chart summarizes the most common events in the criminal and juvenile justice systems including entry into the criminal justice system, prosecution and pretrial services, adjudication, sentencing and sanctions, and corrections. A discussion of the events in the criminal justice system follows.
Image by U.S. Department of Justice, Office of Justice Programs
How Is Opioid Use Disorder Treated in the Criminal Justice System?
Opioid use disorders are highly prevalent among criminal justice populations. According to data from the U.S. Department of Justice, approximately half of state and federal prisoners meet criteria for substance use disorder. Even so, there has been reticence in criminal justice settings to using methadone, buprenorphine, and naltrexone to treat opioid use disorder. In national surveys, utilization of these medications is very low in criminal justice settings, including drug courts, jails, and prisons. Thus, opioid use disorder goes largely untreated during periods of incarceration, and opioid use often resumes after release.
A former inmate’s risk of death within the first 2 weeks of release is more than 12 times that of other individuals, with the leading cause of death being a fatal overdose. Overdoses are more common when a person relapses to drug use after a period of abstinence due to loss of tolerance to the drug. One study found a reduction in post-incarceration deaths from overdose among individuals who had received medication for opioid use disorder in correctional facilities. Untreated opioid use disorders also contribute to a return to criminal activity, reincarceration, and risky behavior contributing to the spread of HIV and hepatitis B and C infections.
The World Health Organization’s Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence recommends that incarcerated individuals should receive adequate healthcare and that opioid withdrawal, agonist maintenance and naltrexone treatment should all be available in prison settings, and prisoners should not be forced to accept any particular treatment."
Many states currently do not offer appropriate access to or utilize medications to treat opioid use disorder among arrestees or inmates even though research has shown many benefits of incorporating medication-assisted treatment into criminal justice treatment programs. Inmates who receive buprenorphine treatment prior to release are more likely to engage in treatment after their release than inmates who only participate in counseling. Participants who engage in methadone treatment and counseling in prison are more likely to enter community-based methadone treatment centers after their release (68.6 percent) than those receiving only counseling (7.8 percent) or those in counseling and referred to a treatment center (50 percent).
In one study, inmates who began buprenorphine treatment while incarcerated engaged in post-release treatment sooner, averaging 3.9 days after release, compared to 9.2 days for participants referred to treatment post-release. They were also likely to stay in treatment longer if they were initiated in treatment prior to release (20.3 weeks on average) than if they began treatment after their release (13.2 weeks).
Inmates who participate in methadone treatment and counseling while in prison are less likely to test positive for illicit opioids at one month following their release (27.6 percent) compared to those who only receive counseling (62.9 percent) and those who receive counseling and a referral to a treatment center (41 percent).
A randomized controlled trial was published in 2016, comparing prison-initiated extended-release naltrexone (XR-NTX) treatment to standard counseling protocols for prevention of opioid relapse. During the treatment phase, relapse was significantly lower in the group receiving XR-NTX (43 percent vs. 64 percent). The XR-NTX group also experienced no overdose events, while there were seven overdose events in the control group.
A survey of community correction agents’ views on using medications to treat opioid use disorder showed that more favorable attitudes toward medication use are associated with greater knowledge about the evidence base for these medications and greater understanding of opioid use disorder as a medical disorder. Organizational linkage between correctional stakeholders and community treatment providers, along with training sessions, can be an effective way to change perceptions and increase knowledge about the efficacy of these medications, and can increase the intent within correctional facilities to refer individuals with opioid use disorder to treatment that incorporates medications.
A mechanism to reduce recidivism and divert nonviolent offenders from traditional jail and prison settings is the drug treatment court model, which provides treatment services in combination with judicial supervision. Still, resistance to medications persists even in this area of the criminal justice system; a survey published in 2013 reported that 50 percent of drug courts did not allow agonist treatment for opioid use disorder under any circumstances. In 2015, the Office of National Drug Control Policy announced that state drug courts receiving federal grants must not: 1) deny any appropriate and eligible client for the treatment drug court access to the program because of their use of FDA-approved medications that is in accordance with an appropriately authorized prescription; or 2) mandate that a drug court client no longer use medications as part of the conditions of the drug court if such a mandate is inconsistent with a medical practitioner’s recommendation or prescription.
Source: National Institute on Drug Abuse (NIDA)
Is It Available in Military?
Suboxone
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Suboxone
Suboxone tablet - both sides.
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Is Medication to Treat Opioid Use Disorder Available in the Military?
Rates of prescription opioid misuse are higher among service members than among civilians. Survey results suggest drug use among returning soldiers is often a coping strategy to treat arousal symptoms of post-traumatic stress disorder. Returning military personnel also experience higher rates of chronic pain and related medical use of opioid pain relievers compared to the civilian population. These data collectively suggest an unmet need for the assessment, management, and treatment of both chronic pain and opioid use disorder in this population.
The Veterans Health Administration (VHA) acknowledges that treatment with opioid agonists (methadone or buprenorphine) is the first-line treatment for opioid use disorder and recommends it for all opioid-dependent patients. Notably, a 2015 revision of treatment guidelines for the U.S. Department of Veteran Affairs and U.S. Department of Defense shifted toward allowing these medications as a treatment option for active duty military members. Still, only about a quarter of patients with an opioid use disorder treated at VHA facilities receive medication. Barriers to opioid agonist medication among VHA providers include lack of perceived patient interest, stigma toward the patient population, and lack of education about opioid agonist treatment.
In the past, lack of insurance coverage for opioid agonist medications was a barrier for use among active duty military; however, as of 2013, TRICARE included coverage for these medications, and a 2016 modification of TRICARE regulation included provisions for expanded coverage of opioid use disorder treatment. This expanded coverage removed annual and lifetime limitations on substance use disorder treatment allowed for office-based opioid treatment, and established opioid treatment programs as a newly recognized category of institutional provider under TRICARE.
Source: National Institute on Drug Abuse (NIDA)
Is It Available in Pregnancy?
Fetal Development and Opioids
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Fetal Development and Opioids
Pregnancy and Opioids
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What Treatment Is Available for Pregnant Mothers and Their Babies?
Paralleling the large recent increases in opioid use, use disorder, and overdose, the incidence of babies born dependent on opioids (neonatal abstinence syndrome, or NAS) as a result of the mother’s opioid use during pregnancy has also greatly increased. Incidence of NAS rose nearly fivefold between 2000 and 2012; this increase was associated with increases in the prescription of opioids to pregnant women for pain, which doubled between 1995 and 2009.
Untreated opioid use disorder during pregnancy can have devastating effects on the fetus. The fluctuating levels of opioids in the blood of mothers misusing opioids expose the fetus to repeated periods of withdrawal, which can also harm the function of the placenta and increase the risk of:
fetal growth restriction
placental abruption
preterm labor
fetal convulsions
intrauterine passage of meconium
fetal death
In addition to these direct physical effects, other risks to the fetus include:
untreated maternal infections such as HIV
malnutrition and poor prenatal care
dangers conferred by drug-seeking lifestyle, including violence and incarceration
Methadone and Buprenorphine as the Standard of Care for Opioid Use Disorder in Pregnancy
To lessen the negative effects of opioid dependence on the fetus, treatment with methadone has been used for pregnant women with opioid use disorder since the 1970s and has been recognized as the standard of care since 1998. Recent evidence, however, suggests that buprenorphine may be an even better treatment option.
Both methadone and buprenorphine treatment during pregnancy:
stabilize fetal levels of opioids, reducing repeated prenatal withdrawal
improve neonatal outcomes
increase maternal HIV treatment to reduce the likelihood of transmitting the virus to the fetus
link mothers to better prenatal care
A meta-analysis showed that, compared to single-dose methadone treatment, buprenorphine resulted in:
10 percent lower incidence of NAS
shorter neonatal treatment time (an average of 8.4 days shorter)
lower amount of morphine used for NAS treatment (an average of 3.6 mg lower)
higher gestational age, weight, and head circumference at birth
Data from the NIDA-funded Maternal Opioid Treatment: Human Experimental Research study show similar benefits of buprenorphine. Still, methadone is associated with higher treatment retention than buprenorphine. Divided dosing with methadone has been explored as a way to reduce fetal exposure to withdrawal periods, and recent data show low levels of NAS in babies born to mothers treated with divided doses of methadone. Larger comparison studies are needed to determine if split methadone dosing for opioid use disorders in pregnancy is associated with better outcomes.
NAS still occurs in babies whose mothers have received buprenorphine or methadone, but it is less severe than it would be in the absence of treatment. Research does not support reducing maternal methadone dose to avoid NAS, as this may promote increased illicit drug use, resulting in increased risk to the fetus.
Source: Jones et al., 2010
Source: National Institute on Drug Abuse (NIDA)
Additional Materials (2)
Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome
Doctors, nurses, or other health professionals should screen every adult patient, including pregnant women, and counsel those who drink too much. Providers can help women avoid drinking too much, including avoiding alcohol during pregnancy, in 5 steps.
Image by CDC/Adapted from American College of Obstetricians and Gynecologists
Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome
Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome Use of opiates during pregnancy can result in a drug withdrawal syndrome in newborns called neonatal abstinence syndrome (NAS). A new study to determine the extent, context, and costs of NAS found that incidence of NAS is rising in the United States. There was a five-fold increase in the proportion of babies born with NAS from 2000 to 2012, when an estimated 21,732 infants were born with NAS -equivalent to one baby suffering from opiate withdrawal born every 25 minutes. Newborns with NAS were more likely than other babies to also have low birthweight and respiratory complications. The number of delivering mothers using or dependent on opiates rose nearly five-fold from 2000 to 2009, to an estimated 23,009. In 2012, newborns with NAS stayed in the hospital an average of 16.9 days (compared to 2.1. days for other newborns), costing hospitals an estimated $1.5 billion; the majority of these charges (81%) were paid by state Medicaid programs, reflecting the greater tendency of opiate-abusing mothers to be from lower-income communities. The rising frequency (and costs) of drug withdrawal in newborns points to the need for measures to reduce antenatal exposure to opiates.Top Graph: Every 25 minutes, 1 baby is born suffering from opiate withdrawal.Bottom Left Graph: Average length or cost of hospital stay graph. Newborns with NAS stayed in the hospital for an average of 16.9 days compared to 2.1 days for those without NAS. The hospital costs for newborns with NAS were $66,700 on average compared to $3,500 for those without NAS.Bottom Right Graph: NAS and maternal opiate use on the rise graph.The rate of babies born with NAS per 1,000 hospital births was 1.2 in 2000, 1.5 in 2003, 1.96 in 2006, 3.39 in 2009 and 5.8 in 2012. The rate of maternal opiate use per 1,000 hospital births was 1.19 in 2000, 1.26 in 2003, 2.52 in 2006, and 5.63 in 2009.References: Patrick et. Al., JAMA 2012, Patrick et. Al., Journal of Perinatology 2015
Image by National Institute on Drug Abuse (NIDA)
Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome
CDC/Adapted from American College of Obstetricians and Gynecologists
Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome
National Institute on Drug Abuse (NIDA)
How Much Does It Cost?
Cost of Treatment
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Cost of Treatment
Cost of Treatment
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How Much Does Opioid Treatment Cost?
Although the price for opioid treatment may vary based on a number of factors, recent preliminary cost estimates from the U.S. Department of Defense for treatment in a certified opioid treatment program (OTP) provide a reasonable basis for comparison:
methadone treatment, including medication and integrated psychosocial and medical support services (assumes daily visits): $126.00 per week or $6,552.00 per year
buprenorphine for a stable patient provided in a certified OTP, including medication and twice-weekly visits: $115.00 per week or $5,980.00 per year
naltrexone provided in an OTP, including drug, drug administration, and related services: $1,176.50 per month or $14,112.00 per year
To put these costs into context, it is useful to compare them with the costs of other conditions. According to the Agency for Healthcare Research and Quality, annual expenditures for individuals who received health care are $3,560.00 for those with diabetes mellitus and $5,624.00 for kidney disease.
It is also important to remember the costs associated with untreated opioid use disorders, including costs associated with:
criminal justice
treating babies born dependent on opioids
greater transmission of infectious diseases
treating overdoses
injuries associated with intoxication (e.g., drugged driving)
lost productivity
The amount paid for treatment of substance use disorders is only a small portion of the costs these disorders impose on society. An analysis suggested that the total costs of prescription opioid use disorders and overdoses in the United States was $78 billion in 2013. Of that, only 3.6 percent, or about $2.8 billion, was for treatment.
Source: National Institute on Drug Abuse (NIDA)
Is Naloxone Accessible?
Naloxone Access
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Naloxone Access
Image by CDC
Is Naloxone Accessible?
Naloxone is an opioid antagonist that can reverse an opioid overdose. Naloxone access increased between 2010 and 2014, with:
more than three times the number of local sites providing naloxone (from 188 to 644)
nearly three times the number of laypersons provided naloxone kits (from 53,032 to 152,283)
a 94 percent increase in states (from 16 to 30), including Washington, DC, with at least one organization providing naloxone
more than 2.5 times the number of overdose reversals reported (from 10,171 to 26,463)
Naloxone prescriptions dispensed from retail pharmacies increased nearly twelvefold between the fourth quarter of 2013 and the second quarter of 2015.
Most states have passed laws to widen the availability to naloxone for family, friends, and other potential bystanders of overdose.
Naloxone has become widely used by emergency medical providers, with all 50 states and the District of Columbia, Guam, and Puerto Rico certifying and approving emergency medical service personnel at the paramedic level to administer naloxone. One step further, emergency medical technicians (EMTs) were explicitly permitted to administer naloxone in 12 of these 53 jurisdictions (23 percent—California, Colorado, District of Columbia, Massachusetts, Maryland, New Mexico, North Carolina, Ohio, Oklahoma, Rhode Island, Virginia, and Vermont) as of November 2013. Because non-paramedic EMTs are typically the first and sometimes only source of emergency care, providing authorization and training for them to administer naloxone is a promising strategy to reduce overdose deaths.
After a naloxone training session, a majority of police officers reported that it would not be difficult to use naloxone at the scene of an overdose (89.7 percent) and that it was important that other officers be trained to use naloxone (82.9 percent).
Effects of Naloxone Distribution
Overdose education and naloxone distribution (OEND) has been shown to increase the reversal of potentially fatal overdoses; one study showed opioid overdose death rates to be 27 to 46 percent lower in communities where OEND was implemented. Among 4,926 people who used substances and participated in OEND in Massachusetts, 373 (7.6 percent) reported administering naloxone during an overdose rescue, with few differences in behavior between trained and untrained overdose rescuers. A naloxone distribution study in San Francisco reported that 11 percent of participants used naloxone during an overdose; of 399 overdose events where naloxone was used, 89 percent were reversed. Brief education is sufficient to improve comfort and competence in recognizing and managing overdose. Prospective studies are needed to determine the optimal level of training and whether naloxone rescue kits can meet the standard for becoming available over the counter.
In a probabilistic analysis, naloxone distribution programs were shown to prevent overdose deaths, increase quality-adjusted life years (QALYs) and be highly cost-effective. Naloxone distribution was predicted to prevent 6 percent of overdose deaths, 1 for every 227 naloxone kits distributed. Cost effectiveness, under markedly conservative predictions, was measured to be $14,000.00 per QALY, well within the standard favorable range of cost-benefit ratios (under $50,000.00 per QALY).
Critics of naloxone distribution have claimed that it could lead to an increase in risky opioid use, but a study in Massachusetts showed rates of opioid-related emergency department visits and hospital admissions were not significantly different in communities with low or high implementation of OEND programs.
Source: National Institute on Drug Abuse (NIDA)
Additional Materials (3)
Increasing naloxone access
Video by WKRN News 2/YouTube
What is naloxone and should everyone have access to it?
Video by Mayo Clinic/YouTube
Nasal Naloxone Access through FNHB
Video by First Nations Health Authority/YouTube
2:29
Increasing naloxone access
WKRN News 2/YouTube
0:49
What is naloxone and should everyone have access to it?
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Medications to Treat Opioid Use Disorder
Effective medications exist to treat opioid use disorder: methadone, buprenorphine, and naltrexone. Learn how these medications could help people recover from opioid use disorder.