Buprenorphine

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.

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 and practitioners are encouraged to report all side effects. FDA’s medical product safety reporting program for health care professionals, patients, and consumers.

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.