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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.

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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
 

Citation

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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
Walsh, James K., Andrew D. Krystal, David A. Amato, Robert Rubens, Judy Caron, Thomas C. Wessel, Kendyl Schaefer, James Roach, Gene Wallenstein, and Thomas Roth. “Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.Sleep 30, no. 8 (August 2007): 959–68. https://doi.org/10.1093/sleep/30.8.959.
Walsh JK, Krystal AD, Amato DA, Rubens R, Caron J, Wessel TC, et al. 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.
Walsh, James K., et al. “Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.Sleep, vol. 30, no. 8, Aug. 2007, pp. 959–68. Pubmed, doi:10.1093/sleep/30.8.959.
Walsh JK, Krystal AD, Amato DA, Rubens R, Caron J, Wessel TC, Schaefer K, Roach J, Wallenstein G, Roth T. Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. Sleep. 2007 Aug;30(8):959–968.
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