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Suboxone (SCH 000484)
Suboxone is a combination of buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) that reduces opioid cravings and withdrawal symptoms while minimizing abuse potential.
Suboxone is a combination of buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) that reduces opioid cravings and withdrawal symptoms while minimizing abuse potential. Used for Opioid use disorder maintenance treatment, Opioid dependence.
At a glance
| Generic name | Suboxone (SCH 000484) |
|---|---|
| Also known as | SCH 000484 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Opioid agonist-antagonist combination |
| Target | Mu-opioid receptor (buprenorphine); opioid receptors (naloxone) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Buprenorphine binds with high affinity to mu-opioid receptors, providing partial agonist activity that alleviates withdrawal symptoms and cravings with a lower overdose risk than full opioid agonists. Naloxone, included as a deterrent to intravenous misuse, blocks opioid receptors and precipitates withdrawal if the combination is injected. Together, these components enable maintenance treatment for opioid use disorder with reduced abuse liability.
Approved indications
- Opioid use disorder maintenance treatment
- Opioid dependence
Common side effects
- Headache
- Constipation
- Nausea
- Insomnia
- Sweating
- Withdrawal symptoms (if inadequately dosed)
- Respiratory depression (at high doses)
Key clinical trials
- Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED) (PHASE4)
- A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED) (PHASE4)
- Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
- Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Suboxone (SCH 000484) CI brief — competitive landscape report
- Suboxone (SCH 000484) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI