Level 1: Likely reliable evidence

A randomized trial evaluated the efficacy of eszopiclone (Lunesta) for insomnia in 410 women aged 40-60 years with onset of insomnia temporally associated with transition to menopause (Obstet Gynecol. 2006;108:1402-1410). Women were randomized to eszopiclone 3 mg or placebo nightly for four weeks; they were treated with single-blind placebo for three to seven days before and seven days after the four-week treatment period. All patients were analyzed by intention-to-treat; 359 patients (88%) completed the study. At baseline, most of the women had sleep latency of 45-59 minutes, sleep duration of five to six hours per night, three to five nocturnal awakenings per night, and wake time after sleep onset 30-60 minutes per night.

Eszopiclone reduced insomnia but was associated with more adverse effects than placebo. Comparing eszopiclone vs. placebo, mean reduction in sleep latency was 25.8 minutes vs. 10.1 minutes (P <.001), mean reduction in wake time after sleep onset was 30.9 minutes vs. 16 minutes (P <.001), and mean increase in total sleep time was 56.6 minutes vs. 33.6 minutes (P <.001).

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The rates of study withdrawal due to adverse events were 5.5% with treatment vs. 1.4% with placebo (P <.05, NNH 24); 57.8% vs. 46.2% had any adverse event (NNH 8), and 17.6% vs. 0.5% reported unpleasant taste (NNH 5). Eszopiclone significantly reduced nocturnal vasomotor symptoms and psychological symptoms compared with placebo.