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Cited by 230Sleep and related disordersObstructive Sleep Apnea ResearchSleep and Work-Related Fatigue

An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia

ROTH, T, WALSH, J, KRYSTAL, A, WESSEL, T, ROEHRS, T·2005·Sleep Medicine
DOI 10.1016/j.sleep.2005.06.004
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Abstract

Background and purpose A double-blind placebo-controlled study of eszopiclone found significant, sustained improvement in sleep and daytime function. The 6-month open-label extension phase is described herein.Patients and methods Adults (21-64) with primary insomnia who reported sleep duration <6.5 h/night or sleep latency >30 min/night were included. Patient-reported endpoints included sleep and daytime function. Safety and compliance were assessed at monthly clinic visits. The final double-blind month was used as the baseline for efficacy analyses of the open-label period.Results Patients who were initially randomized to double-blind placebo and then switched to open-label eszopiclone (n=111) significantly reported the following: (1) decreased sleep latency, wake time after sleep onset, and number of awakenings; (2) increased total sleep time and sleep quality; and (3) improved ratings of daytime ability to function, alertness and sense of physical well-being compared to baseline (P<or=0.0001 all monthly endpoints). There was no evidence of tolerance on any measure in either group. These subjects (n=360) sustained the double-blind treatment gains for all sleep and daytime parameters, with further significant improvement in a number of measures. Eszopiclone was well tolerated in both groups; unpleasant taste was the only undesirable effect reported by >5% of patients.Conclusions The significant improvements in sleep and daytime function were evident in those switched from double-blind placebo to 6 months of open-label eszopiclone therapy and were sustained during the 6 months of open-label treatment for those receiving prior double-blind eszopiclone. During 12 months of nightly treatment, eszopiclone 3mg was well tolerated; tolerance was not observed.

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Authors
ROTH, T., WALSH, J., KRYSTAL, A., WESSEL, T., & ROEHRS, T.
Affiliations
  • Henry Ford Hospital (US)
  • Duke University (US)
  • Sunovion (United States) (US)
Corresponding author
ROTH, T
ORCID
Venue
Sleep Medicine
Publisher
Elsevier BV
Published
2005-11
Volume
6
Issue
6
Pages
487-495
ISSN
1389-9457 (ISSN-L)
DOI
10.1016/j.sleep.2005.06.004
OpenAlex
W2066580767
Cited by
230
References
23
Citations by year
2026: 5 · 2025: 4 · 2024: 7 · 2023: 10 · 2022: 5 · 2021: 6 · 2020: 4 · 2019: 4 · 2018: 9 · 2017: 9 · 2016: 12 · 2015: 10 · 2014: 19 · 2013: 7 · 2012: 13
FWCI
27.21
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Sleep Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
Keywords
eszopiclone, chronic primary insomnia, long-term efficacy, sustained treatment effects, daytime functioning, sleep latency, sleep quality, wake after sleep onset, awakening, drug safety, tolerability, open-label extension
MeSH terms
Adult, Aged, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Piperazines, Treatment Outcome, Cross-Over Studies, Azabicyclo Compounds

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