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Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a fixed-dose combination medication that includes buprenorphine and naloxone.[2] It is used to treat opioid use disorder, and reduces the mortality of opioid use disorder by 50% (namely by reducing the risk of overdose on full-agonist opioids such as heroin or fentanyl).[2][4][5] It relieves cravings to use and withdrawal symptoms.[6] Buprenorphine/naloxone is available for use in two different forms, under the tongue or in the cheek.[1]   

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Side effects may include respiratory depression (decreased breathing), small pupils, sleepiness, and low blood pressure.[2] The risk of overdose with buprenorphine/naloxone (unless combined with other sedating substances) is exceedingly low, and lower than with methadone.[6] However, people are more likely to stop treatment on buprenorphine/naloxone than methadone.[6] Buprenorphine (like methadone) is a treatment option during pregnancy.

Buprenorphine, at lower doses, results in the usual opioid effects; however, high doses beyond a certain level do not result in greater effects.[7] This is believed to result in a lower risk of overdose than some other opioids.[7] Naloxone is an opioid antagonist that competes with and blocks the effect of other opioids (including buprenorphine) if given by injection.[2] Naloxone is poorly absorbed when taken by mouth and it is added to decrease the risk that people will misuse the medication by injection.[1] Misuse by injection or use in the nose, however, still occurs.[2] Rates of misuse in the United States appear to be lower than with other opioids.[8]

The combination formulation was approved for medical use in the United States in October 2002,[2][8][9] and in the European Union in November 2017.[3] A generic version was approved in the US in June 2018.[10] In 2017, it was the 288th most commonly prescribed medication in the United States, with more than one million prescriptions

Medical Use

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Buprenorphine/naloxone is used for the treatment of opioid use disorder.[13] Long term outcomes are generally better with use of buprenorphine/naloxone than attempts at stopping opioid use altogether.[6] This includes a lower risk of overdose with medication use.[6] Due to the high binding affinity and low activation at the opioid receptor, cravings and withdrawal for opioids are decreased while preventing a person from getting high and relapsing on another opioid. The combination of the two medications is preferred over buprenorphine alone for maintenance treatment due to the presence of naloxone in the formulation, which helps discourage intravenous use.[13]

Buprenorphine/naloxone has been found to be effective for treating opioid dependence, and serves as a recommended first line medication according to the U.S. National Institute on Drug Abuse.[8] The medication is an effective maintenance therapy for opioid dependence and has generally similar efficacy to methadone, which are both substantially more effective than abstinence-based treatment.[6][14]

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Because it may be prescribed out of an office setting (as opposed to methadone which requires specialized centers), buprenorphine/naloxone allows for more freedom of administration for the person. It also thus comes with more risks in this vulnerable population. Buprenorphine/naloxone may be recommended for socially stable people who use opioids who may not be able to retrieve medications from a center daily, who may have another condition requiring regular primary care visits, or who may have jobs or daily lives that require they maintain all their faculties and cannot take a sedating medication.[6] Buprenorphine/naloxone is also recommended over methadone in people who may be at high risk of methadone toxicity, such as the elderly, those taking high doses of benzodiazepines or other sedating substances, concomitant alcohol use disorder, those with a lower level of opioid tolerance, and those at high risk of prolonged QT interval. It is also helpful to use the medication in combination with psychosocial support and counseling for the person.[2][15]

Available forms

Buprenorphine/naloxone is available in sublingual formulations (that is, products that are dissolved under the tongue). There is no evidence that the tablet formulation is easier to divert and use in ways other than intended by the prescriber compared to the film formulation, or that the tablet formulation has a higher risk for accidental ingestion by children.[16] There are various pharmacokinetic differences between sublingual formulations

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