Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 11/7/2025

Buprenorphine for Opioid Use Disorder

FDA-Approved Indications

  • The FDA approved buprenorphine in 2002 specifically for the treatment of opioid use disorder/opioid dependence, as stated by the American Medical Association 1, 2
  • Buprenorphine acts as a partial agonist at mu-opioid receptors with high receptor affinity, reducing opioid cravings and withdrawal symptoms, according to the American College of Physicians 4
  • The medication provides a ceiling effect on respiratory depression, making it safer than full agonists like methadone, as recommended by the American Academy of Addiction Psychiatry 4

FDA-Approved Medications for Alcohol Use Disorder

  • The American Society of Addiction Medicine recommends four FDA-approved pharmacotherapies for alcohol use disorder, including Disulfiram, Oral naltrexone, Extended-release injectable naltrexone, and Acamprosate, none of which include buprenorphine 5
  • Disulfiram is approved for increasing abstinence, Oral naltrexone is approved for increasing abstinence, Extended-release injectable naltrexone is approved for increasing proportion of subjects with no heavy drinking days, and Acamprosate is approved for increasing abstinence, as stated by the National Institute on Alcohol Abuse and Alcoholism 5

Clinical Context

  • The American College of Cardiology recommends a therapeutic dose range of 8-16 mg daily of buprenorphine, with 16 mg being optimal for most patients, and must be combined with counseling and behavioral therapies 3, 4, 6
  • Buprenorphine can only be initiated during active opioid withdrawal to prevent precipitated withdrawal, and demonstrates clinical equivalence to methadone in retaining patients in treatment and reducing illicit opioid use, according to the Substance Abuse and Mental Health Services Administration 3, 4, 6