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Adding eszopiclone to escitalopram improves insomnia symptoms in individuals with insomnia, GAD, study shows

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
Among patients with insomnia and comorbid generalized anxiety disorder, cotherapy with escitalopram and eszopiclone significantly improves insomnia symptoms relative to eszopiclone alone, according to findings from a double-blind study. The data also suggest eszopiclone may improve anxiety and mood symptoms as well as ratings of daytime function.

Investigators randomized patients with insomnia and GAD to receive nightly treatment with escitalopram 10 mg plus either eszopiclone 3 mg (n=294) or placebo (n=301) for 8 weeks. Subsequently, all participants received escitalopram plus placebo during a 2-week single-blind runout phase.

Eszopiclone plus escitalopram significantly reduced sleep-onset latency relative to escitalopram plus placebo (mean reduction averaged for the double-blind treatment period, 25.0 minutes vs 11.5 minutes, respectively; P<.0001; the primary endpoint). Eszopiclone-treated patients also exhibited greater improvements in total sleep time and wake after sleep onset. All of these between-group differences were significant after the first week of double-blind treatment.

In addition, participant assessments of sleep quality, depth of sleep, daytime alertness, ability to concentrate, physical well-being, and ability to function were significantly higher in the eszopiclone group than in the placebo group (P<.008 for all).

At week 8, eszopiclone was also associated with greater improvements in anxiety and mood symptoms relative to placebo, as assessed by the Hamilton Rating Scales for Anxiety and Depression (HAM-A and HAM-D, respectively) and the Clinical Global Impressions of Improvement scale (CGI-I).

Specifically, 63% of eszopiclone-treated patients exhibited an anxiolytic response to treatment, defined as a reduction in HAM-A score of ≥50%, compared with 49% of placebo-treated patients (P=.011). Time to onset of an anxiolytic response was also shorter with eszopiclone, regardless of whether a response to treatment was defined as a CGI-I score of ≤2 (18 days vs 28 days; P=.0522) or a HAM-A score reduction of ≥50% (P=.023).

Mean improvements in CGI-Severity scores at week 8 did not significantly differ between the 2 groups (P=.1184).

Overall, adverse events were reported by 67.9% of placebo-treated patients and 77.6% of eszopiclone-treated patients during double-blind treatment. The most common adverse events in the eszopiclone/escitalopram group were unpleasant taste, headache, dry mouth, and somnolence.

The authors noted that there was no evidence of tolerance or rebound insomnia. (Pollack M, et al. Poster P04.035.)

This information may concern a use that has not been approved by the Food and Drug Administration.

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