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Randomized Controlled Trial
. 2007 Jun 15;3(4):374-9.

Efficacy and tolerability of indiplon in transient insomnia

Russell Rosenberg  1 , Thomas Roth, Martin B Scharf, D Alan Lankford, Robert Farber
Affiliations
Randomized Controlled Trial

Efficacy and tolerability of indiplon in transient insomnia

Russell Rosenberg et al. J Clin Sleep Med. .

Abstract

Objective: The efficacy of indiplon was evaluated by polysomnography (PSG) in an experimental model of transient insomnia consisting of the first night effect combined with a 2-hour phase advance.

Methods: Healthy volunteers age 21-64 years (N=593; 62% female; mean +/- SEM) years, 32 +/- 0.39) were randomized to double-blind treatment with a single nighttime dose of indiplon (10 mg or 20 mg) or placebo. PSG assessments included latency to persistent sleep (LPS, primary endpoint) and total sleep time (TST); self-report assessments included sleep quality (SQ); next day residual effects were evaluated by the Digit Symbol Substitution Test (DSST), Symbol Copying Test (SCT), and a Visual Analog Scale of sleepiness (VAS).

Results: LPS mean (+/- SEM) values were significantly reduced on indiplon 10 mg (21.2 +/- 1.5 minutes) and indiplon 20 mg (16.8 +/- 1.1 minutes) compared to placebo (33.1 +/- 2.5 minutes; p < 0.0001 for both comparisons to placebo). TST mean (+/- SEM) values were significantly increased on indiplon 10 mg (414.5 +/- 3.9 minutes) and indiplon 20 mg (423.5 +/- 3.1 minutes) compared to placebo (402.9 +/- 3.9 minutes; p <0.005 for the 10 mg dose; p < 0.0001 for the 20 mg dose). SQ was also significantly improved on both doses. There were no differences between indiplon and placebo on next day DSST, SCT, or VAS.

Conclusions: Indiplon was effective in inducing sleep, increasing sleep duration, and improving overall sleep quality without next day residual effects in healthy volunteers in a model of transient insomnia.

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Figures

Figure 1
Figure 1
Effect of Indiplon on Latency to Persistent Sleep and Latency to Sleep Onset *p <0.0001; p-values based on ANOVA model using log-transformed data; adjusted for multiplicity using Dunnett's test
Figure 2
Figure 2
Subjective Ratings of Sleep Quality on Indiplon *p <0.02; **p <0.0001; p-values from stratified Wilcoxon rank sum test (Cochran-Mantel-Haenszel test with site as a stratum).
Figure 3
Figure 3
Effect of Indiplon Treatment on Sleep Architecture: Mean Number of Minutes In Each Sleep Stage *p <0.01; **p ≤0.0001; p-values based on ANOVA model using rank-transformed data
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