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A polysomnography study of eszopiclone in elderly patients with insomnia.

Publication ,  Journal Article
McCall, WV; Erman, M; Krystal, AD; Rosenberg, R; Scharf, M; Zammit, GK; Wessel, T
Published in: Curr Med Res Opin
September 2006

OBJECTIVE: To evaluate the safety and efficacy of eszopiclone 2 mg in elderly patients (aged 64-86 years) with chronic insomnia. METHODS: This was a randomized, double-blind, placebo-controlled 2-week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] >or= 20 min and latency to persistent sleep >or= 20 min) were randomized to 2 weeks of nightly treatment with eszopiclone 2 mg (n = 136) or placebo (n = 128). Efficacy was assessed using polysomnography (Nights 1, 2, 13, and 14) and patient reports (Nights 1-14); safety was assessed using adverse events, clinical labs, physical examination, and vital signs. The mean of all efficacy results during the double-blind period was used for the efficacy analysis. RESULTS: Results indicated that eszopiclone was associated with significantly shorter sleep onset, less WASO, higher sleep efficiency, more total sleep time, and greater patient-reported quality and depth of sleep scores than placebo (p < 0.05 for all) with a trend in patient-reported morning sleepiness (p = 0.07). Other measures of daytime functioning (ability to function, daytime alertness, and sense of well-being) were not significantly different between the two treatment groups. Among patients who napped, eszopiclone patients reported fewer naps (p = 0.03) and less cumulative naptime (median: 98 min placebo, 70 min eszopiclone, p = 0.07). Unpleasant taste, dry mouth, somnolence, and dizziness were higher in the eszopiclone group (12.5%, 8.8%, 6.6%, and 6.6%, respectively) than in the placebo group (0%, 1.6%, 5.5%, and 1.6%, respectively). CONCLUSION: In this study, eszopiclone was well tolerated and produced significant improvements in both polysomnographic and patient-reported measures of sleep maintenance, sleep induction, and sleep duration in elderly patients with chronic primary insomnia.

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Published In

Curr Med Res Opin

DOI

ISSN

0300-7995

Publication Date

September 2006

Volume

22

Issue

9

Start / End Page

1633 / 1642

Location

England

Related Subject Headings

  • Sleep Initiation and Maintenance Disorders
  • Polysomnography
  • Placebos
  • Piperazines
  • Middle Aged
  • Male
  • Hypnotics and Sedatives
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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McCall, W. V., Erman, M., Krystal, A. D., Rosenberg, R., Scharf, M., Zammit, G. K., & Wessel, T. (2006). A polysomnography study of eszopiclone in elderly patients with insomnia. Curr Med Res Opin, 22(9), 1633–1642. https://doi.org/10.1185/030079906X112741
McCall, W Vaughn, Milton Erman, Andrew D. Krystal, Russell Rosenberg, Martin Scharf, Gary K. Zammit, and Thomas Wessel. “A polysomnography study of eszopiclone in elderly patients with insomnia.Curr Med Res Opin 22, no. 9 (September 2006): 1633–42. https://doi.org/10.1185/030079906X112741.
McCall WV, Erman M, Krystal AD, Rosenberg R, Scharf M, Zammit GK, et al. A polysomnography study of eszopiclone in elderly patients with insomnia. Curr Med Res Opin. 2006 Sep;22(9):1633–42.
McCall, W. Vaughn, et al. “A polysomnography study of eszopiclone in elderly patients with insomnia.Curr Med Res Opin, vol. 22, no. 9, Sept. 2006, pp. 1633–42. Pubmed, doi:10.1185/030079906X112741.
McCall WV, Erman M, Krystal AD, Rosenberg R, Scharf M, Zammit GK, Wessel T. A polysomnography study of eszopiclone in elderly patients with insomnia. Curr Med Res Opin. 2006 Sep;22(9):1633–1642.

Published In

Curr Med Res Opin

DOI

ISSN

0300-7995

Publication Date

September 2006

Volume

22

Issue

9

Start / End Page

1633 / 1642

Location

England

Related Subject Headings

  • Sleep Initiation and Maintenance Disorders
  • Polysomnography
  • Placebos
  • Piperazines
  • Middle Aged
  • Male
  • Hypnotics and Sedatives
  • Humans
  • General & Internal Medicine
  • Female