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

Publication ,  Journal Article
Walsh, JK; Krystal, AD; Amato, DA; Rubens, R; Caron, J; Wessel, TC; Schaefer, K; Roach, J; Wallenstein, G; Roth, T
Published in: Sleep
August 2007

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.

Duke Scholars

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Published In

Sleep

DOI

ISSN

0161-8105

Publication Date

August 2007

Volume

30

Issue

8

Start / End Page

959 / 968

Location

United States

Related Subject Headings

  • Work Capacity Evaluation
  • Wakefulness
  • Social Adjustment
  • Sleep Initiation and Maintenance Disorders
  • Quality of Life
  • Piperazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Long-Term Care
 

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Walsh, J. K., Krystal, A. D., Amato, D. A., Rubens, R., Caron, J., Wessel, T. C., … Roth, T. (2007). Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. Sleep, 30(8), 959–968. https://doi.org/10.1093/sleep/30.8.959
Journal cover image

Published In

Sleep

DOI

ISSN

0161-8105

Publication Date

August 2007

Volume

30

Issue

8

Start / End Page

959 / 968

Location

United States

Related Subject Headings

  • Work Capacity Evaluation
  • Wakefulness
  • Social Adjustment
  • Sleep Initiation and Maintenance Disorders
  • Quality of Life
  • Piperazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Long-Term Care