Buprenorphine and naloxone: uses, side effects and safety
Buprenorphine and naloxone (Suboxone, Suboxone Film) is a opioid use disorder treatment; opioid analgesic (partial agonist plus antagonist). It is a US Schedule III controlled substance. It is prescription only (rx) and remains on the US market.
What is Buprenorphine and naloxone?
Buprenorphine and naloxone is the generic name for Suboxone, Suboxone Film, and belongs to the Opioid use disorder treatment; opioid analgesic (partial agonist plus antagonist) class.
| Generic name | Buprenorphine HCl and naloxone HCl (sublingual film) |
|---|---|
| Brand name(s) | Suboxone, Suboxone Film |
| Drug class | Opioid use disorder treatment; opioid analgesic (partial agonist plus antagonist) |
| US legal status | US Schedule III ยท Prescription only (Rx) |
| Route | Oral |
| Prescription required | Yes |
| Elimination half-life | 24-42 (buprenorphine) |
How does Buprenorphine and naloxone work?
Buprenorphine is a partial opioid agonist and naloxone is an opioid antagonist; indicated for treatment of opioid dependence..
The elimination half-life is roughly 24-42 (buprenorphine). Longer half-lives mean the drug and its active metabolites persist in the body for longer after the last dose.
Common side effects of Buprenorphine and naloxone
These are the side effects people report most often. Many diminish after the body adjusts, usually within one to two weeks.
- headache
- nausea
- vomiting
- constipation
- abdominal pain
- diarrhea
- sweating
- insomnia
Serious side effects and warning signs
Seek emergency care for any of these
- severe respiratory depression
- adrenal insufficiency
- hepatotoxicity
- neonatal withdrawal syndrome
- opioid withdrawal/overdose during induction
Suspected overdose or a bad reaction should be reported to Poison Control on 1-800-222-1222. That is staffed around the clock and is free.
Legal status of Buprenorphine and naloxone
Buprenorphine and naloxone is a Schedule III controlled substance in the United States. That placement is set out in Title 21 of the Code of Federal Regulations, Part 1308, and enforced by the Drug Enforcement Administration. It carries restrictions on prescribing, storage, record-keeping and transfer.
Statutory reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a5edcf9-828c-4f97-b671-268ab13a8ecd.
Can you get Buprenorphine and naloxone without a prescription?
Short answer: no. Buprenorphine and naloxone is a prescription medication. Sites advertising it without one are either operating illegally or selling something other than what they claim. We explain the legal routes, the counterfeit problem and how to check a source in detail.
Read the full answer: Buprenorphine and naloxone without a prescription →
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Narcotic (opioid) analgesic combination productMedication information page.
Read more →Frequently asked questions
What is Buprenorphine and naloxone used for?
See the approved uses section below.
What schedule is Buprenorphine and naloxone in the United States?
Buprenorphine and naloxone is a Schedule III controlled substance in the US, listed at 21 CFR Part 1308. Schedule III means the drug has a defined potential for abuse and is subject to federal record-keeping, storage and prescribing restrictions.
What are the common side effects of Buprenorphine and naloxone?
The most frequently reported side effects are headache, nausea, vomiting, constipation, abdominal pain, diarrhea. Many lessen over the first week or two of treatment.
Sources & references
Important
This site provides educational information only and does not sell, prescribe or dispense medications. Always consult a licensed healthcare provider. This page is not medical advice.