Methadone

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 practitioner to gradually reduce their methadone dosage to prevent withdrawal.

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.

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.

Learn more from the SAMHSA publication Follow Directions: How to Use Methadone Safely – 2009 (also available in Spanish).

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.

Read Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants (PDF | 2.2 MB).

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.

Listen to APA’s Medical Mind Podcast Transitioning from Methadone to Buprenorphine.