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Sleep. 2007 Aug;30(8):959-68.

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

Author information

1
Sleep Medicine and Research Center, St. John's/St. Luke's Hospitals and the Department of Psychology, Saint Louis University, St. Louis, MO 63017, USA. jwalsh@stlo.mercy.net

Abstract

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.

PMID:
17702264
PMCID:
PMC1978384
DOI:
10.1093/sleep/30.8.959
[Indexed for MEDLINE]
Free PMC Article

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