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Eszopiclone demonstrates moderate to strong effect sizes on sleep outcomes relative to placebo in patients with primary insomnia, insomnia with comorbidities

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Eszopiclone therapy appears to provide moderate to strong effects on a number of outcome measures among patients with primary insomnia (PI) and patients who have insomnia with comorbid major depressive disorder, generalized anxiety disorder, perimenopausal transition (PMT), or rheumatoid arthritis, with the largest effects observed among patients with PI, new data show.

Researchers assessed sleep-wake symptoms among the various patient populations from 5 double-blind, randomized trials (PI, n=830; MDD, n=545; GAD, n=595; PMT, n=410; RA, n=153) that ranged in duration from 4 weeks to 6 months. In all of the trials, the patients were treated with eszopiclone 3 mg or placebo; the patients with MDD or GAD also received a selective serotonin reuptake inhibitor on an open-label basis.

To calculate relative effect sizes, the researchers used the absolute value of the difference between the 2 treatment means divided by the pooled standard deviation; 0.3 represented a moderate effect and 0.5 represented a strong effect. Sleep outcomes included patient-reported sleep latency (SL; primary outcome), wake after sleep onset (WASO), total sleep time (TST), sleep quality, daytime functioning, and Insomnia Severity Index scores.

"Eszopiclone was associated with a moderate to large effect size on all sleep outcomes and daytime outcomes ... in each of the insomnia populations," said Thomas Roth, head of the Henry Ford Sleep Disorders and Research Center in Detroit, who presented the study findings.

Specifically, moderate to strong effect sizes with eszopiclone were observed in all of the studies by week 1 for SL (0.47-0.63), WASO (0.40-0.69), TST (0.44-0.65), and sleep quality (0.50-0.77). After 4 weeks of treatment, the values for SL were 0.33-0.63; for WASO, 0.28-0.43; for TST, 0.27-0.61; and for sleep quality, 0.29-0.61.

"Very importantly, once you get beyond the first week ..., consistently, primary insomniacs showed the highest effect sizes," Roth said. This result was most notable for the measures of next-day functioning, data showed.

The study authors noted that concomitant SSRI therapy in the patients with comorbid psychiatric conditions did not diminish the insomnia-related effect sizes. (Schaefer K, et al. Poster #0716.)

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