[1] Side effects may include respiratory depression (decreased breathing), small pupils, sleepiness, and low blood pressure.
[3] Naloxone is poorly absorbed when taken by mouth and is added to decrease the risk that people will misuse the medication by injection.
The combination of the two medications is preferred over buprenorphine alone for maintenance treatment due to the presence of naloxone in the formulation, which is believed to help discourage intravenous use.
[9] Buprenorphine/naloxone is effective for treating opioid dependence and serves as a recommended first-line medication according to the U.S. National Institute on Drug Abuse.
[16] All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for opioid use disorder in their practice if permitted by applicable state law.
Because it may now be prescribed much more readily out of an office setting (as opposed to methadone, which requires specialized centers), buprenorphine/naloxone allows people more access to this medication and more freedom of administration.
Buprenorphine/naloxone may be recommended for socially stable people who use opioids who cannot retrieve medications from a center daily, who have another condition requiring regular primary care visits, or who have jobs or daily lives that require they maintain all their faculties and cannot take a sedating medication.
[21] The most common side effects seen in film formulations are tongue pain, decreased sensation and redness in the mouth, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of opioid withdrawal, sleeping difficulties, pain, and swelling of the extremities.
The sublingual formulation of the buprenorphine/naloxone combination was designed to reduce the potential to inject the medication in comparison to buprenorphine alone.
When an opioid-dependent person dissolves and injects a combination sublingual tablet, it is believed that a withdrawal effect may be triggered because of naloxone's high parenteral bioavailability.
[28][29] Buprenorphine's sedating/narcotic effect is increased by other sedating substances, such as other opioids, benzodiazepines, first-generation antihistamines, alcohol, and antipsychotics.
[3][17] Buprenorphine binds strongly to opioid receptors and acts as a pain-reducing medication in the central nervous system (CNS).
[34] Before the Drug Addiction Treatment Act of 2000 (DATA), physicians were not allowed to prescribe narcotics to treat opioid dependence.
Integrating Medication-Assisted Treatment into outpatient primary care practices improves patient access to Suboxone.
[35] Some physicians are also leading a movement to begin prescribing it out of the emergency department (ED), as some small studies have shown ED-initiated Suboxone to be effective with people more likely to remain in addiction treatment compared to those either referred to addiction treatment programs or those receiving just a brief intervention in the department.
[36][37] Access to Suboxone can be limited due to varying prior authorization requirements across different insurers.
Financial access is determined through prior authorization approval, which the prescriber must request before the person can start the medication.
Several insurance companies, as well as Medicaid in various states, have removed the use of prior authorization for Suboxone in an attempt to increase access to this treatment.
[40] This record was surpassed in October 2020, when Purdue Pharma reached an $8 billion settlement for claims related to injuries and deaths caused by the opioid epidemic, which includes criminal fines, forfeiture, and civil damages.
[41] The 2019 case alleged anti-competitive behavior by RB Group and Indivior surrounding the expiration of their regulatory exclusivity for Suboxone sublingual tablets.