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A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.

Publication ,  Journal Article
Ancoli-Israel, S; Krystal, AD; McCall, WV; Schaefer, K; Wilson, A; Claus, R; Rubens, R; Roth, T
Published in: Sleep
February 2010

BACKGROUND: Longer-term pharmacologic studies for insomnia in older individuals are sparse. OBJECTIVE: To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia. METHODS: Participants (65-85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) < or = 6 h, and wake time after sleep onset (WASO) > or = 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, wellbeing, ability to function) were assessed. AEs were monitored. RESULTS: Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values < or = 0.01), indicating no rebound. The most common AEs (> or = 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%). CONCLUSION: In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and were maintained for 3 months, with no evidence of rebound insomnia following discontinuation. The 12 weeks of treatment were well tolerated. CLINICAL TRIAL INFORMATION: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia; Registration #NCT00386334; URL - http://www.clinicaltrials.gov/ct2/show/NCT00386334?term=eszopiclone&rank=24

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Published In

Sleep

DOI

ISSN

0161-8105

Publication Date

February 2010

Volume

33

Issue

2

Start / End Page

225 / 234

Location

United States

Related Subject Headings

  • Wakefulness
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Piperazines
  • Patient Satisfaction
  • Neurology & Neurosurgery
  • Male
  • Hypnotics and Sedatives
  • Humans
 

Citation

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Ancoli-Israel, S., Krystal, A. D., McCall, W. V., Schaefer, K., Wilson, A., Claus, R., … Roth, T. (2010). A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep, 33(2), 225–234. https://doi.org/10.1093/sleep/33.2.225
Ancoli-Israel, Sonia, Andrew D. Krystal, W Vaughn McCall, Kendyl Schaefer, Amy Wilson, Raymond Claus, Robert Rubens, and Thomas Roth. “A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.Sleep 33, no. 2 (February 2010): 225–34. https://doi.org/10.1093/sleep/33.2.225.
Ancoli-Israel, Sonia, et al. “A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.Sleep, vol. 33, no. 2, Feb. 2010, pp. 225–34. Pubmed, doi:10.1093/sleep/33.2.225.
Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb;33(2):225–234.
Journal cover image

Published In

Sleep

DOI

ISSN

0161-8105

Publication Date

February 2010

Volume

33

Issue

2

Start / End Page

225 / 234

Location

United States

Related Subject Headings

  • Wakefulness
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Piperazines
  • Patient Satisfaction
  • Neurology & Neurosurgery
  • Male
  • Hypnotics and Sedatives
  • Humans