Efficacy and tolerability of modified-release indiplon in elderly patients with chronic insomnia: results of a 2-week double-blind, placebo-controlled trial.

Abstract

STUDY OBJECTIVE:

Indiplon is a nonbenzodiazepine GABA potentiator, which exhibits pharmacologic selectivity for GABA(A) receptors containing the alpha1 subunit. The aim of the present study was to evaluate the efficacy and safety of a 15-mg nightly dose of modified-release indiplon tablets in elderly patients with primary insomnia characterized by sleep-maintenance difficulties.

METHODS:

Two hundred twenty-nine elderly patients, aged 65 to 85 years, who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for primary insomnia were randomly assigned to 2 weeks of nightly treatment with either indiplon, 15 mg, or placebo in a double-blind, parallel-group design. Daily sleep diaries were completed to collect patient reports of subjective total sleep time, wake time after sleep onset, number of awakenings after sleep-onset, latency to sleep onset, and sleep quality. Patient global impression ratings of various parameters of sleep were assessed on a weekly basis.

RESULTS:

The least square mean total sleep time was significantly improved with indiplon versus placebo at week 1 (377 +/- 4 min vs. 328 +/- 4 min; p < .0001) and week 2 (373 +/- 5 min vs. 337 +/- 5 min; p < .0001). Indiplon also significantly improved subjective wake after sleep onset, subjective number of awakenings after sleep onset, subjective sleep-onset latency, sleep quality, and patient global impression ratings of sleep at both weeks 1 and 2. The number and severity of adverse events and rates of discontinuation due to adverse effects were comparable in the indiplon and placebo groups.

CONCLUSIONS:

In elderly patients with primary insomnia characterized by sleep-maintenance difficulty, indiplon, 15 mg, was well tolerated and significantly improved all patient-reported measures of sleep during 2 weeks of treatment.

• Authors: R Bruce Lydiard, D Alan Lankford, David J Seiden, Rick Landin, Robert Farber, James K Walsh
• Journal: Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine (J Clin Sleep Med) Vol. 2 Issue 3 Pg. 309-15 (Jul 15 2006) ISSN: 1550-9389 [Print] United States
• PMID: 17561543 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Delayed-Action Preparations
• Hypnotics and Sedatives
• Thiophenes
• Benzodiazepines
• indiplon

Topics

• Aged
• Benzodiazepines (administration & dosage, therapeutic use)
• Chronic Disease
• Delayed-Action Preparations
• Double-Blind Method
• Drug Tolerance
• Female
• Humans
• Hypnotics and Sedatives (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Sleep Initiation and Maintenance Disorders (diagnosis, drug therapy)
• Thiophenes (administration & dosage, therapeutic use)