The effect of pregabalin on pain-related sleep interference in diabetic peripheral neuropathy or postherpetic neuralgia: a review of nine clinical trials.

Objective: Postherpetic neuralgia and painful diabetic peripheral neuropathy are common chronic neuropathic pain conditions associated with sleep disturbances. Pregabalin is indicated in the treatment of neuropathic pain. The objective of this review is to summarize the efficacy and safety of pregabalin in painful diabetic peripheral neuropathy and postherpetic neuralgia and the effect of pregabalin on sleep interference in these patients.

Methods: MEDLINE and ISI Web of Knowledge databases were searched for randomized double-blind, placebo-controlled clinical trials of pregabalin reporting sleep measures in addition to pain endpoints in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia published from inception through March 2009.

Results: Nine trials met the inclusion criteria, providing data for a total of 2399 patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated twice or three times per day with pregabalin (75-600 mg/day) or placebo on a fixed or flexible schedule. Interpretation of sleep outcomes in two studies may be limited by trial inclusion criteria which permitted benzodiazepines for sleep problems. Also, none of the studies reported objective sleep measures. Pregabalin was well tolerated. Pregabalin (150-600 mg/day) significantly reduced pain and improved pain-related sleep interference.

Conclusions: In addition to an analgesic benefit, pregabalin may decrease pain-related sleep interference in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia.