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

Sleep. 2007 Aug;30(8):959-68. doi: 10.1093/sleep/30.8.959.


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) < or = 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-controlled 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Arousal / drug effects
  • Azabicyclo Compounds
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives / adverse effects
  • Hypnotics and Sedatives / therapeutic use*
  • Long-Term Care
  • Male
  • Middle Aged
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Quality of Life / psychology*
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Sleep Initiation and Maintenance Disorders / psychology
  • Social Adjustment
  • Wakefulness / drug effects
  • Work Capacity Evaluation*


  • Azabicyclo Compounds
  • Hypnotics and Sedatives
  • Piperazines
  • zopiclone