What is Buprenorphine?
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In October 2002, the Food and Drug Administration (FDA) approved buprenorphine products for use in opioid addiction treatment. The buprenorphine products endorsed by the Buprenorphine Products Manufacturers Group, Suboxone Film, and Zubslov Sublingual Tablets are designed to decrease the potential for abuse by injection. These are currently the only Schedule III, IV, or V medications to have received FDA approval for this indication. Note that aside from these buprenorphine products, other forms of buprenorphine (e.g., Buprenex®) are not approved for treatment of opioid addiction.
Information on formulations is available on the individual Web sites for each product: the Buprenorphine Products Manufacturers Group, Suboxone Film, and Zubslov Sublingual Tablets.
Buprenorphine is an opioid partial agonist. This means that, although buprenorphine is an opioid, and thus can produce typical opioid agonist effects and side effects such as euphoria and respiratory depression, its maximal effects are less than those of full agonists like heroin and methadone. At low doses buprenorphine produces sufficient agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. The agonist effects of buprenorphine increase linearly with increasing doses of the drug until at moderate doses they reach a plateau and no longer continue to increase with further increases in dosethe ceiling effect. Thus, buprenorphine carries a lower risk of abuse, addiction, and side effects compared to full opioid agonists. In fact, in high doses and under certain circumstances, buprenorphine can actually block the effects of full opioid agonists and can precipitate withdrawal symptoms if administered to an opioid-addicted individual while a full agonist is in the bloodstream.
Because of its ceiling effect and poor bioavailability, buprenorphine is safer in overdose than opioid full agonists. The maximal effects of buprenorphine appear to occur in the 1632 mg dose range for sublingual tablets. Higher doses are unlikely to produce greater effects.
Side effects of buprenorphine are similar to those of other opioids and include nausea, vomiting, and constipation. Buprenorphine and buprenorphine/naloxone can precipitate the opioid withdrawal syndrome. Additionally, the withdrawal syndrome can be precipitated in individuals maintained on buprenorphine. Signs and symptoms of opioid withdrawal include:
Refer to the Web sites for the individual products (the Buprenorphine Products Manufacturers Group, Suboxone Film, and Zubslov Sublingual Tablets) for a complete listing of drug interactions, contraindications, warnings, and precautions.
Because of its opioid agonist effects, buprenorphine is abusable, particularly by individuals who are not physically addicted to opioids. Naloxone is added to buprenorphine to decrease the likelihood of diversion and abuse of the combination product. Sublingual buprenorphine has moderate bioavailability, while sublingual naloxone has poor bioavailability. Thus, when the buprenorphine/naloxone tablet is taken in sublingual form, the buprenorphine opioid agonist effect predominates, and the naloxone does not precipitate opioid withdrawal in the opioid-addicted user.
Effective treatment of drug addiction requires comprehensive attention to all of an individuals medical and psychosocial co-morbidities. Pharmacological therapy alone rarely achieves long-term success. Thus treatment with buprenorphine products should be combined with concurrent behavioral therapies and with the provision of needed social services. This point is of such importance that physicians must attest to their capacity to refer patients for counseling when they submit their Notification of Intent to SAMHSA to begin prescribing buprenorphine products.
This section provides a brief overview of the clinical use of buprenorphine products for opioid addiction therapy. For detailed information on this topic see the Buprenorphine Clinical Practice Guidelines.
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