Nightly treatment of primary insomnia with eszopiclone for six months : Effect on sleep, quality of life, and work limitations

To evaluate 6 months' eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations. Randomized, double blind, controlled clinical trial. 54 research sites in the U.S. 830 primary insomnia patients who reported mean nightly total sleep time (TST) < or = 6.5 hours/night and/or mean nightly sleep latency (SL) >30 min. Eszopiclone 3 mg or matching placebo. Patient-reported sleep measures, Insomnia Severity Index, Medical Outcomes Study Short-Form Health Survey (SF-36), Work Limitations Questionnaire, and other assessments measured during baseline, treatment Months 1-6, and 2 weeks following discontinuation of treatment. Patient-reported sleep and daytime function were improved more with eszopiclone than with placebo at all months (P