Buprenorphine/naloxone

Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a fixed-dose combination medication that includes buprenorphine and naloxone. It is used to treat opioid use disorder, and reduces the mortality of opioid use disorder by 50% (by reducing the risk of overdose on full-agonist opioids such as heroin or fentanyl). It relieves cravings to use and withdrawal symptoms. Buprenorphine/­naloxone is available for use in two different forms, under the tongue or in the cheek.

Buprenorphine/naloxone
Buprenorphine, an opioid
Naloxone, an opioid antagonist
Combination of
BuprenorphineOpioid modulator
NaloxoneOpioid antagonist
Clinical data
Trade namesSuboxone, Bunavail, Zubsolv, others
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: C
Routes of
administration
Sublingual, buccal
ATC code
Legal status
Legal status
  • AU: S8 (Controlled drug)
  • CA: ℞-only
  • UK: POM (Prescription only)
  • US: Schedule III
  • EU: Rx-only
Identifiers
CAS Number
PubChem CID
KEGG
CompTox Dashboard (EPA)

Side effects may include respiratory depression (decreased breathing), small pupils, sleepiness, and low blood pressure. The risk of overdose with buprenorphine/­naloxone (unless combined with other sedating substances) is exceedingly low, and lower than with methadone, but people are more likely to stop treatment on buprenorphine/­naloxone than methadone. Buprenorphine (like methadone) is a treatment option during pregnancy.

At lower doses, buprenorphine results in the usual opioid effects; high doses beyond a certain level do not result in greater effects. This is believed to result in a lower risk of overdose than some other opioids. Naloxone is an opioid antagonist that competes with and blocks the effect of other opioids (including buprenorphine) if given by injection. Naloxone is poorly absorbed when taken by mouth and is added to decrease the risk that people will misuse the medication by injection. Misuse by injection or use in the nose still occurs, and more recently the efficacy of naloxone in preventing misuse by injection has been brought into question and preparations including naloxone could even be less safe than preparations containing solely buprenorphine. Rates of misuse in the U.S. appear to be lower than with other opioids.

The combination formulation was approved for medical use in the U.S. in 2002, and in the European Union in 2017. A generic version was approved in the U.S. in 2018. In 2019, it was the 272nd most commonly prescribed medication in the U.S., with more than 1 million prescriptions.

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