Return to Home Ensuring Appropriate Use Educating Patients Resources for Healthcare Professionals

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)
SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII)
SUBUTEX® (buprenorphine) Sublingual Tablet (CIII)


Prescribers play an important role in reducing the risks of accidental overdose, misuse, and abuse, associated with buprenorphine-containing transmucosal products. To help mitigate these risks, prescribers should:

  • Verify the patient meets appropriate diagnostic criteria.
  • Check state Prescription Drug Monitoring Programs, where practical, to identify behaviors that may represent abuse and review all medications (e.g., benzodiazepines, other opioids, and CNS depressants) to assess for appropriateness of co-prescribing.
  • Discuss the risks (including misuse and abuse) and side effects associated with buprenorphine-containing products, including those described in the Medication Guide (See the brochure, Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers for important safety information regarding these risks).
  • Strongly consider prescribing naloxone. Explain the importance of having access to naloxone with the patient.
  • Discuss the importance of having access to naloxone with patient and caregiver, if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
  • Explain what patients should do if they experience side effects.
  • Provide induction doses under appropriate supervision.
  • Prescribe a limited amount of medication to the patient that will last until the next visit.
  • Explain how to safely store the medication out of sight and reach of all others, especially children.
  • Schedule patient appointments commensurate with patient stability (weekly or more frequent visits recommended for the first month).
  • Consider "pill/film count/dose" reconciliation.
  • Assess:
    • whether patient is receiving counseling/psychosocial support considered necessary for treatment and if not, encourage them to do so.
    • whether patient is making progress toward treatment goals (including, as appropriate, urine toxicology testing).
    • the appropriateness of maintenance dose.
    • whether or not benefits of treatment outweigh the risks.

To prescribe products covered under the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets REMS, a prescriber must be certified to treat opioid dependence under the Drug Addiction Treatment Act of 2000 (DATA 2000). For certification information, click here.

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