A polysomnography study of eszopiclone in elderly patients with insomnia

W. Vaughn McCall, Milton Erman, Andrew D. Krystal, Russell Rosenberg, Martin Scharf, Gary K. Zammit, Thomas Wessel

Research output: Contribution to journalArticle

70 Citations (Scopus)

Abstract

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] ≥ 20 min and latency to persistent sleep a 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.

Original languageEnglish (US)
Pages (from-to)1633-1642
Number of pages10
JournalCurrent Medical Research and Opinion
Volume22
Issue number9
DOIs
StatePublished - Sep 1 2006

Fingerprint

Polysomnography
Sleep Initiation and Maintenance Disorders
Sleep
Placebos
Wakefulness
Eszopiclone
Safety
Aptitude
Vital Signs
Dizziness
Diagnostic and Statistical Manual of Mental Disorders
Physical Examination
Mouth
Maintenance
Efficiency

Keywords

  • Elderly
  • Eszopiclone
  • Insomnia
  • Polysomnography
  • Sleep maintenance
  • Sleep onset

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. Current Medical Research and Opinion, 22(9), 1633-1642. https://doi.org/10.1185/030079906X112741

A polysomnography study of eszopiclone in elderly patients with insomnia. / McCall, W. Vaughn; Erman, Milton; Krystal, Andrew D.; Rosenberg, Russell; Scharf, Martin; Zammit, Gary K.; Wessel, Thomas.

In: Current Medical Research and Opinion, Vol. 22, No. 9, 01.09.2006, p. 1633-1642.

Research output: Contribution to journalArticle

McCall, WV, Erman, M, Krystal, AD, Rosenberg, R, Scharf, M, Zammit, GK & Wessel, T 2006, 'A polysomnography study of eszopiclone in elderly patients with insomnia', Current Medical Research and Opinion, vol. 22, no. 9, pp. 1633-1642. https://doi.org/10.1185/030079906X112741
McCall, W. Vaughn ; Erman, Milton ; Krystal, Andrew D. ; Rosenberg, Russell ; Scharf, Martin ; Zammit, Gary K. ; Wessel, Thomas. / A polysomnography study of eszopiclone in elderly patients with insomnia. In: Current Medical Research and Opinion. 2006 ; Vol. 22, No. 9. pp. 1633-1642.
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abstract = "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] ≥ 20 min and latency to persistent sleep a 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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N2 - 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] ≥ 20 min and latency to persistent sleep a 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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