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SUBOXONE is a sublingual tablet indicated for the treatment of opioid dependence.
SUBOXONE combines a partial opioid agonist (buprenorphine) and an opioid antagonist (naloxone) in a 4:1 (buprenorphine: naloxone) ratio.
Buprenorphine (the primary active compound) reduces patients' opioid cravings and withdrawal symptoms. In addition, buprenorphine may discourage patients' use of nonprescribed opioids by binding to the mu receptor, thereby blocking other opioids' effects.1
The naloxone component in SUBOXONE is included to help discourage diversion and misuse. Naloxone has very limited bioavailability when administered sublingually, as intended. However, if SUBOXONE is crushed and injected, the naloxone will precipitate opioid withdrawal. In the absence of an opioid, the antagonist has no effect.
Buprenorphine's low intrinsic activity causes less euphoria than full opioid agonists, resulting in a lower potential for abuse, but sufficient positive effects to aid in compliance. The low intrinsic activity of buprenorphine also has been shown to produce less physical dependence compared with that of full opioid agonists. Buprenorphine's slow dissociation from the mu receptor prolongs its therapeutic effect and contributes to SUBOXONE's relatively mild withdrawal profile.1
The efficacy of SUBOXONE was evaluated in a 4-week, randomized, double-blind, placebo- and active-controlled trial of 326 opioid-dependent patients. Participants were seen daily (M-F) and received up to 1 hour of individual counseling each week. At trial close, the primary efficacy endpoint (percentage of urine samples negative for nonstudy opioids) was significantly higher for SUBOXONE (17.8%) compared with placebo (5.8%) (P<.001).2
In a similar trial evaluating the efficacy of 4 different doses of buprenorphine, significantly more patients in the 16-mg group had urine samples negative for nonstudy opioids (26.8%) compared with the 1-mg group (8.6%) over a 4-week period (P<.001).3
SUBOXONE is generally safe and well tolerated. As with other medications in this class, the most commonly reported side effects for SUBOXONE include headache (36% vs 22% placebo), withdrawal syndrome (25% vs 37% placebo), pain (22% vs 19% placebo), nausea (15% vs 11% placebo), insomnia (14% vs 16% placebo), and sweating (14% vs 10% placebo).
SUBOXONE can reduce respiratory rate. However, because buprenorphine is a partial opioid agonist, when taken alone it exhibits a ceiling dose beyond which no greater effect is observed on physiologic or subjective measures.4 This "ceiling effect" on respiratory depression—unlike full opioid agonists with which respiratory depression continues increasing as the dose increases—means SUBOXONE by itself is unlikely to cause death in the event of an overdose.4
In spite of buprenorphine's favorable safety profile, caution is advised regarding its concomitant use with other sedatives, such as benzodiazepines, due to the additive effects exerted by buprenorphine.5 Inappropriate concomitant use (eg, higher doses than prescribed, parenteral administration) of psychotropics (especially benzodiazepines) and buprenorphine appears to be one of the risk factors for buprenorphine-related fatalities.6,7
There are no clinical data to suggest that medically supervised withdrawal from SUBOXONE offers any short- or long-term benefits over indefinite maintenance therapy. In the absence of a compelling patient need or desire to be completely opioid-free, maintenance therapy is preferred because it is associated with better treatment retention.8
Please see complete Prescribing Information [PDF–Size: 575KB]
| 1. | Walsh SL, Eissenberg T. The clinical pharmacology of buprenorphine: extrapolating from the laboratory to the clinic. Drug Alcohol Depend. 2003;70(suppl 2):S13-S27. |
| 2. | Fudala PJ, Bridge TP, Herbert S, et al, for the Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349:949-958. |
| 3. | Ling W, Charuvastra C, Collins JF, et al. Buprenorphine maintenance treatment of opiate dependence: a multicenter, randomized clinical trial. Addiction. 1998;93:475-486. |
| 4. | Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994;55:569-580. |
| 5. | Buprenex Prescribing Information. Richmond, Va: Reckitt Benckiser Pharmaceuticals, Inc; July 2001. |
| 6. | Kintz P. Deaths involving buprenorphine: a compendium of French cases. Forensic Sci Int. 2001;121:65-69. |
| 7. | Kintz P. A new series of 13 buprenorphine-related deaths. Clin Biochem. 2002;35:513-516. |
| 8. | Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004. |