The use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders. Medications used are approved by the Food and Drug Administration (FDA) and are clinically driven and tailored to meet each patient’s needs.

Research shows that a combination of medication and therapy can successfully treat substance use disorders, and for some medications can help sustain recovery. Medications are also used to prevent or reduce opioid overdose.

The ultimate goal is full recovery, including the ability to live a self-directed life. This treatment approach has been shown to:

• Improve patient survival
• Increase retention in treatment
• Decrease illicit opiate use and other criminal activity among people with substance use disorders
• Increase patients’ ability to gain and maintain employment
• Improve birth outcomes among women who have substance use disorders and are pregnant

Research also shows that these medications and therapies can contribute to lowering a person’s risk of contracting HIV or hepatitis C by reducing the potential for relapse.

Medications for Substance Use Disorders

FDA has approved several different medications to treat alcohol use disorders (AUD) and opioid use disorders (OUD). These medications relieve the withdrawal symptoms and psychological cravings that cause chemical imbalances in the body. Medications used are evidence-based treatment options and do not just substitute one drug for another.

Medications for Alcohol Use Disorder (MAUD)

Acamprosate, disulfiram, and naltrexone are the most common medications used to treat alcohol use disorder. They do not provide a cure for the disorder but are most effective for people who participate in a treatment program.

Medications for Opioid Use Disorder (MOUD)

Buprenorphine, methadone, and naltrexone are the most common medications used to treat OUD. These medications operate to normalize brain chemistry, block the euphoric effects of alcohol and opioids, relieve physiological cravings, and normalize body functions without the negative and euphoric effects of the substance used.

Buprenorphine, methadone, and naltrexone are used to treat OUD to short-acting opioids such as heroin, morphine, and codeine, as well as semi-synthetic opioids like oxycodone and hydrocodone. These medications are safe to use for months, years, or even a lifetime. As with any medication, consult your doctor before discontinuing use.

Opioid Overdose Prevention Medication

Naloxone and nalmefene are both FDA-approved opioid overdose reversal medications (OORMs) that are used to prevent opioid overdose by reversing the toxic effects of the overdose. According to the World Health Organization (WHO), naloxone is one of a number of medications considered essential to a functioning health care system.

Medications and Child Safety

It’s important to remember that if medications are allowed to be kept at home, they must be locked in a safe place away from children. Methadone in its liquid form is colored and can be mistaken for a fruit juice. Children who mistakenly take medications may overdose or have an adverse reaction. Assistance needs to be sought for any known or suspected accidental ingestion.

Prevent children from accidentally taking medication by storing it out of reach.

Medications for Substance Use Disorders

The Food and Drug Administration (FDA) has approved several different medications to treat Alcohol and Opioid Use Disorders. These relieve the withdrawal symptoms and psychological cravings that cause chemical imbalances in the body. Medications used for treatment are evidence-based treatment options.

Some of the medications used as part of a treatment protocol are controlled substances due to their potential for misuse. Drugs, substances, and certain chemicals used to make drugs are classified by the Drug Enforcement Administration (DEA) into five distinct categories, or schedules, depending upon a drug’s acceptable medical use and potential for misuse.

Medications for Alcohol Use Disorder (MAUD)

Acamprosate, disulfiram, and naltrexone are the most common drugs used to treat alcohol use disorder (AUD). They do not provide a cure for the disorder but are most effective in people who participate in a MAUD program.

• Acamprosate - for people in recovery, who are no longer drinking alcohol and want to avoid drinking. It works to prevent people from drinking alcohol, but it does not prevent withdrawal symptoms after people drink alcohol. The use of acamprosate typically begins on the fifth day of abstinence, reaching full effectiveness in five to eight days. It is taken in tablet form three times a day.
• Disulfiram - treats chronic alcoholism and is most effective in people who have already stopped drinking alcohol or are in the initial stage of abstinence. Taken in a tablet form once a day, disulfiram should never be taken while intoxicated and it should not be taken for at least 12 hours after drinking alcohol. Unpleasant side effects (nausea, headache, vomiting, chest pains, difficulty breathing) can occur as soon as ten minutes after drinking even a small amount of alcohol.
• Naltrexone - blocks the euphoric effects and feelings of intoxication and allows people with alcohol use disorders to reduce alcohol use and to remain motivated to continue to take the medication, stay in treatment, and avoid relapses.

Medications for Opioid Use Disorder (MOUD)

Buprenorphine, methadone, and naltrexone are used to treat opioid use disorders (OUD) to short-acting opioids such as heroin, morphine, and codeine, as well as semi-synthetic opioids like oxycodone and hydrocodone. These medications are safe to use for months, years, or even a lifetime. As with any medication, consult your doctor before discontinuing use.

• Buprenorphine - suppresses and reduces cravings for opioids.
• Methadone - reduces opioid cravings and withdrawal and blunts or blocks the effects of opioids.
• Naltrexone - blocks the euphoric and sedative effects of opioids and prevents feelings of euphoria.

Opioid Overdose Prevention Medication

Naloxone and nalmefene are both FDA-approved opioid overdose reversal medications (OORMs) that saves lives by reversing the toxic effects of overdose. According to the World Health Organization (WHO), naloxone is one of a number of medications considered essential to a functioning health care system.

• Naloxone – used to prevent opioid overdose, naloxone reverses the toxic effects of the overdose. In March 2023, the FDA approved naloxone nasal spray as the first over the counter OORM and is available in many pharmacies, through community-based distribution programs, local public health organizations or local health departments, free of charge.
• Nalmefene – an FDA-approved OORM nasal spray that is available by prescription only and is intended for use in health care and community settings for individuals who are 12 years old and over.

Counseling and Behavioral Therapies

Under federal law 42 CFR 8.12, opioid treatment programs (OTPs) must be able to provide counseling, along with medical, vocational, educational, and other assessment and treatment services.

Regardless of what setting medication is provided, it is more effective when counseling and other services are available to provide patients with a whole-person approach and to support their recovery.

Co-Occurring Disorders and Other Health Conditions

The coexistence of both a substance use disorder and a mental illness, known as co-occurring disorders, is common among people with Substance Use Disorders. In addition, individuals may have other health related conditions such a hepatitis, HIV and AIDS.

What is Buprenorphine?

Buprenorphine is the first medication to treat opioid use disorder (OUD) that can be prescribed or dispensed in physician offices, significantly increasing access to treatment. As with all medications used in treatment, buprenorphine should be prescribed as part of a comprehensive treatment plan that includes counseling and other services to provide patients with a whole-person approach.

Buprenorphine offers several benefits to those with OUD and to others for whom treatment in an Opioid Treatment Clinic is not appropriate or is less convenient.

The following buprenorphine products are FDA approved for the treatment of OUD:

• Generic Buprenorphine/naloxone sublingual tablets
• Buprenorphine sublingual tablets (Subutex)
• Buprenorphine/naloxone sublingual films (Suboxone)
• Buprenorphine/naloxone) sublingual tablets (Zubsolv)
• Buprenorphine/naloxone buccal film (Bunavail)
• Buprenorphine implants (Probuphine)
• Buprenorphine extended-release injection (Sublocade)

Refer to the individual product websites for a complete listing of drug interactions, warnings, and precautions.

In addition, buprenorphine is also administered at SAMHSA-certified opioid treatment programs (OTPs).

How Does Buprenorphine Work?

Buprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With buprenorphine, however, these effects are weaker than full opioid agonists such as methadone and heroin. When taken as prescribed, buprenorphine is safe and effective.

Buprenorphine has unique pharmacological properties that:

• Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings
• Increase safety in cases of overdose
• Lower the potential for misuse

Buprenorphine for Opioid Use Disorder

To begin treatment, an OUD patient must abstain from using opioids for at least 12 to 24 hours and be in the early stages of opioid withdrawal. Patents with opioids in their bloodstream or who are not in the early stages of withdrawal, may experience acute withdrawal.

After a patient has discontinued or greatly reduced their opioid use, no longer has cravings, and is experiencing few, if any, side effects, if needed, the dose of buprenorphine may be adjusted. Due to the long-acting agent of buprenorphine, once patients are stabilized, it may be possible to switch from every day to alternate-day dosing.

The length of time a patient receives buprenorphine is tailored to meet the needs of each patient, and in some cases, treatment can be indefinite. To prevent possible relapse, individuals can engage in on-going treatment—with or without MOUD.

Buprenorphine Safety Precautions

Because of buprenorphine’s opioid effects, it can be misused, particularly by people who do not have an opioid dependency. Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product.

Use the following precautions when taking buprenorphine:

• Do not take other medications without first consulting your doctor.
• Do not use illegal drugs, drink alcohol, or take sedatives, tranquilizers, or other drugs that slow breathing. Mixing large amounts of other medications with buprenorphine can lead to overdose or death.
• Ensure that a physician monitors any liver-related health issues that you may have.
• Tell your doctor if you are pregnant or plan to become pregnant.
• Prevent children and pets from accidental Ingestion by storing it out of reach. For more information, visit CDC’s Up and Away educational campaign.
• Dispose of unused methadone safely. Talk to your MOUD practitioner for guidance, or for more information on the safe disposal of unused medications, visit FDA's disposal of unused medicines or DEA's drug disposal webpages
• Do not shared your buprenorphine with anyone even if they have similar symptoms or suffer from the same condition.

Common and Serious Side Effects of Buprenorphine

Patients who are considering buprenorphine for treatment should be sure they fully understand the medication and its side effects before they take the medication. Their health care practitioner or pharmacist can provide this information. Patients should tell their health care practitioner about any side effects that are bothersome or do not go away.

Patients and practitioners are encouraged to report all side effects online to MEDWatch, FDA’s medical product safety reporting program for health care professionals, patients, and consumers or by calling 1-800-FDA-1088.

Common side effects of buprenorphine include:

• Constipation, headache, nausea, and vomiting
• Dizziness
• Drowsiness and fatigue
• Sweating
• Dry mouth
• Tooth decay
• Muscle aches and cramps
• Inability to sleep
• Fever
• Blurred vision or dilated pupils
• Tremors
• Palpitations
• Disturbance in attention

Serious side effects of buprenorphine include:

• Respiratory distress
• Overdose
• Adrenal insufficiency
• Dependence
• Withdrawal
• Itching, pain, swelling, and nerve damage (implant)
• Pain at injection site (injection)
• Neonatal abstinence syndrome (in newborns)

Pregnant or Breastfeeding Women and Buprenorphine

Buprenorphine may be prescribed to women who are pregnant and have an OUD. Buprenorphine and methadone are considered the treatments of choice for OUD in pregnant and breastfeeding women.

What Is Methadone?

Methadone is a medication used to treat Opioid Use Disorder (OUD). Methadone is a long-acting full opioid agonist, and a schedule II controlled medication. Methadone used to treat those with a confirmed diagnosis of opioid use disorder (OUD) can only be dispensed through a SAMHSA certified OTP.

Methadone is a medication approved by the Food and Drug Administration (FDA) to treat OUD as well as for pain management. When taken as prescribed, methadone is safe and effective. Methadone helps individuals achieve and sustain recovery and to reclaim active and meaningful lives. Methadone is one component of a comprehensive treatment plan, which includes counseling and other behavioral health therapies to provide patients with a whole-person approach. Under federal law 42 CFR 8.12, patients receiving treatment in Opioid Treatment Programs (OTPs) must be able to receive counseling through the OTP, along with medical, vocational, educational, and other assessment and treatment services.

How Does Methadone Work?

Methadone, a long-acting opioid agonist, reduces opioid craving and withdrawal and blunts or blocks the effects of opioids. Taken daily, it is available in liquid, powder and diskettes forms.

How Can a Patient Receive Methadone?

Patients taking methadone to treat OUD must receive the medication under the supervision of a practitioner. After a period of stability (based on progress and proven, consistent compliance with the medication dosage), patients may be allowed to take methadone at home between program visits.

The length of time a person receives methadone treatment varies. According to the National Institute on Drug Abuse publication Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition), the length of methadone treatment should be a minimum of 12 months. Some patients may require long-term maintenance. Patients must work with their MAT practitioner to gradually reduce their methadone dosage to prevent withdrawal.

Methadone Safety

Methadone is safe and effective, when taken as prescribed. Methadone medication is specifically tailored for the individual patient (and doses are often adjusted and readjusted) and is never to be shared with or given to others. This is particularly important for patients who take methadone at home and are not required to take medication under direct supervision at an OTP.

Patients should share their complete health history with health providers to ensure the safe use of the medication.

Other medications may interact with methadone and cause heart conditions. Even after the effects of methadone wear off, the medication’s active ingredients remain in the body for much longer. Unintentional overdose is possible if patients do not take methadone as prescribed.

The following tips can help achieve the best treatment results:

• Never use more than the amount prescribed, and always take at the times prescribed. If a dose is missed, or if it feels like it’s not working, do not take an extra dose of methadone
• Do not consume alcohol while taking methadone.
• Be careful driving or operating machinery on methadone.
• Call 911 if too much methadone is taken or if an overdose is suspected.
• Prevent children and pets from accidental ingestion by storing it out of reach. For more information, visit CDC’s Up and Away educational campaign.
• Store methadone at room temperature and away from light.
• Do not shared your methadone with anyone even if they have similar symptoms or suffer from the same condition.
• Dispose of unused methadone safely. Talk to your MOUD practitioner for guidance, or for more information on the safe disposal of unused medications, visit FDA's disposal of unused medicines or DEA's drug disposal webpages.

Common and Serious Side Effects of Methadone

Side effects should be taken seriously, as some of them may indicate an emergency. Patients should stop taking methadone and contact a doctor or emergency services right away.

Patients and practitioners are encouraged to report all side effects online to MEDWatch, FDA’s medical product safety reporting program for health care professionals, patients, and consumers or by calling 1-800-FDA-1088.

Common side effects of methadone include:

• Restlessness
• Nausea or vomiting
• Slow breathing
• Itchy skin
• Heavy sweating
• Constipation
• Sexual problems

Serious side effects of methadone include:

• Experience difficulty breathing or shallow breathing
• Feel lightheaded or faint
• Experience hives or a rash; swelling of the face, lips, tongue, or throat
• Feel chest pain
• Experience a fast or pounding heartbeat
• Experience hallucinations or confusion

Pregnant or Breastfeeding Women and Methadone

Women who are pregnant or breastfeeding can safely take methadone. Comprehensive methadone maintenance treatment should include prenatal care to reduce the risks of complications during pregnancy and at birth.

Undergoing methadone maintenance treatment while pregnant does not cause birth defects. Methadone’s ability to prevent withdrawal symptoms helps pregnant women better manage their Opioid Use Disorder (OUD) while avoiding health risks to both mother and baby. Pregnant woman who experience withdrawal may be at risk of miscarriage or premature birth, as withdrawal can cause the uterus to contract.

It is possible that some babies may experience withdrawal, also known as neonatal abstinence syndrome (NAS) after birth. Symptoms may begin within minutes to hours after birth, with most symptoms appearing within 72 hours. It is possible for symptoms to appear as late as up to two weeks after birth. It is important to speak with your physician, as NAS is influenced by many factors.

Research has shown that the benefits of breastfeeding outweigh the effect of the small amount of methadone that enters the breast milk.

Switching from One Form of Medication to Another

Patients may decide to switch from one medication to another based on medical, psychiatric and substance use history, as well as their preferences and treatment availability. As medications are different, patients should talk to their practitioner and understand each medication.

Naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD).

What Is Naltrexone?

Intramuscular extended release naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both opioid use disorder (OUD) and alcohol use disorder (AUD). Naltrexone can be prescribed and administered by any practitioner licensed to prescribe medications and is available in a pill form for AUD or as an extended-release intramuscular injectable for AUD and OUD. 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.

How Does Naltrexone Work?

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.

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.

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.

SAMHSA funds the Providers Clinical Support System – Medications for Opioid Use Disorders (PCSS-MOUD) to provide free training and mentoring to medical practitioners to identify and treat opioid use disorder.

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.

SAMHSA funds the Providers Clinical Support System – Medications for Alcohol Use Disorders (PCSS-MAUD) to provide free training and mentoring to medical practitioners to identify and treat alcohol use disorder.

Naltrexone Safety Precautions

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

Common and Serious Side Effects of Naltrexone

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.

Patients and practitioners are encouraged to report all side effects online to MEDWatch, FDA’s medical product safety reporting program for health care professionals, patients, and consumers, or by calling 1-800-FDA-1088.

Common side effects may include:

• nausea
• sleepiness
• headache
• dizziness
• vomiting
• decreased appetite
• painful joints
• muscle cramps
• cold symptoms
• trouble sleeping
• toothache

Serious side effects of Naltrexone may include:

• Severe reactions at the site of injection, including: intense pain; tissue death for which surgery may be required; swelling, lumps, or hardness; scabs, blisters, or open wounds
• Liver damage or hepatitis, including; stomach area pain lasting more than a few days; dark urine; yellowing of the whites of your eyes; tiredness
• Serious allergic reactions, including: skin rash; swelling of face, eyes, mouth, or tongue; trouble breathing or wheezing; chest pain; feeling dizzy or faint
• Pneumonia
• Depressed mood

What are the Risks of an Opioid Overdose?

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 OUD 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.

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.

Dispose of unused naltrexone safely. Talk to your physician for guidance, or for more information on the safe disposal of unused medications, visit FDA's disposal of unused medicines or DEA's drug disposal webpages.

Opioid overdose reversal medications (OORMs) are lifesaving medications approved by the Food and Drug Administration (FDA) to reverse an opioid overdose. Two FDA-approved OORMs are naloxone and nalmefene. Examples of opioids include heroin, fentanyl, oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, and morphine.

OORMs are effective in reversing opioid overdose, even in instances when opioids are used in combination with other sedatives or stimulants. OORMs are not effective in treating overdoses of benzodiazepines or stimulant overdoses involving cocaine and amphetamines.

It is critical to obtain medical intervention as soon as possible after administering/receiving an OORM.

You can learn how to administer an OORM from a doctor, pharmacist, or staff at a local harm reduction center. Additionally, there are online resources for naloxone administration and rescue breathing.

What Is Naloxone?

Naloxone is a medication approved by the Food and Drug Administration (FDA) designed to rapidly reverse opioid overdose. It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin, morphine, and oxycodone. Administered when a patient is showing signs of opioid overdose, naloxone is a temporary treatment and its effects do not last long.

The medication can be given by intranasal spray (into the nose), intramuscular (into the muscle), subcutaneous (under the skin), or intravenous (into a vein) injection.

A practitioner should assess the need to prescribe naloxone for patients who are taking methadone or buprenorphine receiving or otherwise considered a risk for opioid overdose.

In March 2023, the FDA approved naloxone nasal spray as the first over the counter OORM and is available in many pharmacies, through community-based distribution programs, local public health organizations or local health departments, free of charge. Check with your state for your local naloxone availability and restrictions.

What Is Nalmefene?

Nalmefene is another FDA-approved OORM nasal spray that is available by prescription only and is intended for use in health care and community settings for individuals who are 12 years old and over.

Nalmefene is an opioid receptor antagonist used to treat acute opioid overdose. However, it has a higher half-life than naloxone which means it can stay in the body for longer. This can make withdrawal symptoms more severe and last longer.

Candidates for OORMs are those who:

• Take high doses of opioids for long-term management of chronic pain
• Receive rotating opioid medication regimens
• Have been discharged from emergency medical care following opioid poisoning or intoxication
• Take certain extended-release or long-acting opioid medication
• Those who have had a period of abstinence to include those recently released from incarceration.

Pregnant women can be safely given both naloxone and nalmefene in limited doses under the supervision of a doctor. Nalmefene can cause opioid withdrawal in an unborn baby so it is important that practitioners know the medication has been used so the patient and baby can be monitored.

Patients prescribed an automatic injection device for naloxone or who use the nasal spray should keep the item available at all times. It is important to remember to replace medication when the expiration date passes and if exposed to temperatures below 39°F or above 104°F.

Nalmefene should be kept at room-temperature and away from direct sunlight. It is important to remember to replace medication when the expiration date passes.

Side Effects of OORMS

Serious side effects should be taken seriously, as some of them may indicate an emergency. Patients should stop taking methadone and contact a doctor or emergency services right away. Patients and practitioners are encouraged to report all side effects online to MEDWatch, FDA’s medical product safety reporting program for health care professionals, patients, and consumers or by calling 1-800-FDA-1088.

Patients who experience an allergic reaction, such as hives or swelling in the face, lips, or throat, should seek medical help immediately. They should not drive or perform other potentially unsafe tasks.

Use of OORMs causes symptoms of opioid withdrawal. Medical assistance must be obtained as soon as possible after administering/receiving an OORM.

Opioid withdrawal symptoms include:

• Feeling nervous, restless, or irritable
• Body aches
• Dizziness or weakness
• Diarrhea, stomach pain, or nausea
• Fever, chills, or goose bumps
• Sneezing or runny nose in the absence of a cold

Opioid Overdose

Opioid overdose is life-threatening and requires immediate emergency attention. Recognizing the signs of opioid overdose is essential to saving lives.

Opioid overdose can happen when:

• A patient misunderstands the directions for use, accidentally takes an extra dose, or deliberately misuses a prescription opioid
• A person uses illicit drugs
• A person takes opioid medications prescribed for someone else
• A person mixes opioids with other medications, alcohol, or over-the-counter drugs

Signs of opioid overdose:

• Person does not wake or respond to touch or voice
• Breathing is not normal, very slow, or has stopped
• Pin-point sized pupils
• Bluish lips and nose

What is Opioid Overdose?

Substance use disorders (SUDs) impact the lives of millions of Americans. More than 100,000 people died from drug overdoses from April 2020 to 2021, an increase of 28.5% from the prior year, according to a report by the Centers for Disease Control and Prevention (CDC).

An opioid overdose can occur when a person:

• Overdoses on an illicit opioid drug, such as heroin or morphine
• Overdoses on methadone
• Accidentally takes an extra dose
• Deliberately misuses a prescription opioid or opioid-based pain medication in way that was not as prescribed by their physician
• Mixes opioids with other prescriptions, alcohol, or over-the-counter medications. Overdoses can be fatal when mixing an opioid with anxiety treatment medications or derivatives of Benzodiazepine, such as Xanax or valium.
• Uses medication prescribed for someone else. Children are particularly vulnerable to accidental overdoses if they take medication not intended for them.

How to Prevent Opioid Overdose

Opioid overdose can occur even with prescription opioid pain relievers and medications used in treating SUD such as methadone and buprenorphine. In addition, individuals using naltrexone for MOUD have a reduced tolerance to opioids, and therefore, using the same, or even lower doses of opioids used in the past, can cause life-threating consequences.

Always follow the instructions you receive with your medication. Ask your practitioner or pharmacist if you have questions or are unsure of how to take your medication.

The following tips can help you or a loved one avoid opioid overdose:

• Take medicine as prescribed by your practitioner
• Do not take more medication or take it more often than instructed
• Never mix pain medicines with alcohol, sleeping pills, or illicit substances
• Never take anyone else medication
• Prevent children and pets from accidental ingestion by storing your medication out or reach.
• Dispose of unused medication safely. Talk to your MOUD practitioner for guidance, or for more information on the safe disposal of unused medications, visit FDA's disposal of unused medicines or DEA's drug disposal webpages.

How to Recognize Opioid Overdose

Opioid overdose is life-threatening and requires immediate emergency attention. Recognizing the signs of opioid overdose is essential to saving lives.

Call 911 immediately if a person exhibits ANY of the following symptoms:

• Their face is extremely pale and/or feels clammy to the touch
• Their body goes limp
• Their fingernails or lips have a purple or blue color
• They start vomiting or making gurgling noises
• They cannot be awakened or are unable to speak
• Their breathing or heartbeat slows or stops

How to Treat Opioid Overdose

Family members, caregivers, or the people who spend time with individuals using opioids need to know how to recognize the signs of an overdose and how to administer life-saving services until emergency medical help arrives. Individuals experiencing an opioid overdose will not be able to treat themselves. Naloxone was approved by the Food and Drug Administration (FDA) as the first over the counter medication to prevent opioid overdose. Check with your healthcare provider, pharmacy, community-based distribution programs, local public health organizations or the local health departments on how to obtain naloxone in your state.

If you suspect someone is experiencing an opioid overdose, take action immediately:

• Call 911
• Begin CPR if the person has stopped breathing or if breathing is very weak (best performed by someone who has training)
• Treat the person with naloxone or nalmefene to reverse opioid overdose (if available)

Fentanyl

Fentanyl is a synthetic opioid used for treating severe pain and is 50 to 100 times more potent than morphine. Most recent cases of fentanyl-related harm, overdose and death in the United States are linked to illicitly made fentanyl. Illicitly made fentanyl is often found in counterfeit pills, which are made to look like prescription drugs or may be added to other illicit drugs such as methamphetamine or cocaine. The risk of overdose exists when fentanyl is present given its potency and uncertain amount in the drug supply, but risk is especially high among persons who are not tolerant to it and may not be aware of the presence of fentanyl in what they are using.

Fentanyl Test Strips

Fentanyl test strips (FTS) are a low-cost method of helping prevent drug overdoses and reducing harm. FTS are small strips of paper that can be used to determine if drugs have been mixed or contaminated with fentanyl, providing people who use drugs and communities with important information about fentanyl in the illicit drug supply so they can take steps to reduce their risk of overdose.

Xylazine

Xylazine is a non-opioid sedative that is approved by FDA for animal use, but not for people. Xylazine is increasingly added to other drugs such as cocaine, heroin, or fentanyl to enhance the effect or increase street value. Xylazine is dangerous because it can depress breathing, blood pressure, heart rate and body temperature to critical levels and, in combination with fentanyl, can make overdose reversal challenging.

Xylazine Test Strips

Xylazine test strips (XTS) are small strips of paper that can be placed within a personal sample of drugs to detect the presence of xylazine. Such strips may be used to inform decisions about drug use practices; for example, upon receiving a positive test result, an individual may opt to not use the drugs or use them in a less risky manner.

What are Co-Occurring Disorders?

People with substance use disorders (SUDs) are at particular risk for developing one or more primary conditions or chronic diseases. The coexistence of both a mental illness and SUD is known as a co-occurring disorder, and is common among people in treatment.

People with mental illness are more likely to experience an SUD than those not affected by a mental illness. According to SAMHSA’s 2022 National Survey on Drug Use and Health, approximately 21.5 million adults in the United States have a co-occurring disorder.

It is important to note that combining medications used for SUD with anxiety treatment medications can have serious adverse effects. Common benzodiazepines include Xanax, Valium, Klonopin among others.

Co-occurring disorders may include any combination of two or more SUDs and mental disorders identified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR). No specific combinations of mental and substance use disorders are defined uniquely as co-occurring disorders.

The most common mental disorders:

• Anxiety and mood disorders
• Schizophrenia
• Bipolar disorder
• Major depressive disorder
• Conduct disorders
• Post-traumatic stress disorder
• Attention deficit hyperactivity disorder

Patients being treated for mental disorders often misuse the following types of substances:

• Alcohol
• Tobacco
• Opioids
• Stimulants
• Marijuana
• Hallucinogens
• Prescription drugs

HIV, AIDS, and Viral Hepatitis

HIV, AIDS, and viral hepatitis are important public health concerns for both patients and health professionals in substance use disorder treatment programs. Use of medications for SUD treatment typically involves HIV and hepatitis antibody testing at admission, or a referral for antibody testing.

HIV and hepatitis prevention and reduced transmission are key goals of OTPs and other programs designed to treat substance use disorders. In addition, HIV testing and risk-reduction counseling, have been shown to stop or decrease drug use and related risk behaviors, including risky injection practices and unsafe sex.

HIV and AIDS in Treatment

Drug use is an important driver of the HIV epidemic. According to the CDC’s HIV and Injection Drug Use, about 1 in 10 new HIV diagnoses in the United States are attributed to injection drug use (2,492 cases) and male-to-male sexual contact and injection drug use (1,372 cases). CDC reports that in 2018, adult and adolescent people who inject drugs in the US accounted for 10 percent of all new HIV diagnoses.

HIV is transmitted by contact with the blood or other body fluids of an infected person. This can occur during unprotected sex or through the sharing of needles. In addition, untreated infected women can pass HIV to their infants during pregnancy, delivery, and breastfeeding. Alcohol and drug misuse can also worsen the symptoms of HIV, causing greater neuronal injury and cognitive impairment.

Hepatitis in Treatment

There are three major strains of hepatitis virus infection: hepatitis A, hepatitis B, and hepatitis C. People at high risk for infection can be protected by vaccination against hepatitis A and hepatitis B. Currently, there is no vaccination against hepatitis C.

• Hepatitis A – A self-limiting foodborne pathogen, can induce severe liver disease in drug users already infected with another hepatitis virus.
• Hepatitis B – Can be spread through sexual contact, blood transfusions, or by the re-use of contaminated needles.
• Hepatitis C – Injection drug use is the major source of hepatitis C infection in the United States, and a risk factor for contracting and spreading hepatitis C.

While there is no one-size-fits-all solution for helping a family member who is drinking too much, using drugs, or dealing with a mental illness, research shows that family support can play a major role in helping a loved one with mental and substance use disorders.

When a family member is experiencing a mental or substance use disorder, it can affect more than just the person in need of recovery. Evidence has shown that some people have a genetic predisposition for developing mental and substance use disorders, and may be at greater risk based on environmental factors such as having grown up in a home affected by a family member’s mental health or history of substance use. Families should be open to the options of support groups or family therapy and counseling, which can improve treatment effectiveness by supporting the whole family.

It is also important to remember that the unique challenges that come from helping a loved one with a mental or substance use disorder can be taxing, so caregivers should take steps to prioritize their own health as well.

Family members may be more likely to notice when their loved ones are experiencing changes in mood or behavior. Being able to offer support, family members can connect those in need with treatment, resources, and services to begin and stay on their recovery journey.