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

Study Objectives: To evaluate 6 months' eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations. Design: Randomized, double blind, controlled clinical trial. Setting: 54 research sites in the U.S. Patients: 830 primary insomnia patients who reported mean nightly total sleep time (TST) <= 6.5 hours/night and/or mean nightly sleep latency (SL) > 30 min. Intervention: Eszopiclone 3 mg or matching placebo. Measurements: 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. Results: Patient-reported sleep and daytime function were improved more with eszopiclone than with placebo at all months (P < 0.001). Eszopiclone reduced Insomnia Severity Index scores to below clinically meaningful levels for 50% of patients (vs 19% with placebo; P < 0.05) at Month 6. SF-36 domains of Physical Functioning, Vitality, and Social Functioning were improved with eszopiclone vs placebo for the Month 1-6 average (P < 0.05). Similarly, improvements were observed for all domains of the Work Limitations Questionnaire with eszopiclone vs placebo for the Month 1-6 average (P < 0.05). Conclusions: This is the first placebo-control led investigation to demonstrate that long-term nightly pharmacologic treatment of primary insomnia with any hypnotic enhanced quality of life, reduced work limitations, and reduced global insomnia severity, in addition to improving patient-reported sleep variables.