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Nightly Treatment of Primary Insomnia With Eszopiclone for Six Months: Effect on Sleep, Quality of Life, and Work Limitations

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Walsh, James K., Krystal, Andrew D., Amato, David A., Rubens, Robert, Caron, Judy, Wessel, Thomas C., Schaefer, Kendyl, Roach, James, Wallenstein, Gene, Roth, Thomas·2007·Sleep

DOI 10.1093/sleep/30.8.959PMC PMC1978384

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Abstract

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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Authors: Walsh, J. K., Krystal, A. D., Amato, D. A., Rubens, R., Caron, J., Wessel, T. C., Schaefer, K., Roach, J., Wallenstein, G., & Roth, T.
Affiliations: Saint Louis University (US)
Duke Medical Center (US)
Sunovion (United States) (US)
Henry Ford Hospital (US)
Corresponding author: Walsh, James K.
ORCID: Walsh, James K.
Krystal, Andrew D.
Caron, Judy
Wallenstein, Gene
Roth, Thomas
Venue: Sleep
Publisher: Oxford University Press (OUP)
Published: 2007-08
Volume: 30
Issue: 8
Pages: 959-968
ISSN: 0161-8105 (ISSN-L)
1550-9109
DOI: 10.1093/sleep/30.8.959
PMC: PMC1978384
OpenAlex: W2127024218
Cited by: 239
References: 30
Citations by year: 2026: 9 · 2025: 5 · 2024: 8 · 2023: 4 · 2022: 5 · 2021: 10 · 2020: 10 · 2019: 8 · 2018: 9 · 2017: 8 · 2016: 16 · 2015: 11 · 2014: 13 · 2013: 11 · 2012: 20
FWCI: 32.41
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: SLEEP (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Pfizer
GlaxoSmithKline
Sanofi
Neurocrine Biosciences
National Institutes of Health
Topics: Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
Keywords: eszopiclone, primary insomnia, sleep quality, quality of life, work limitations, insomnia severity, daytime fatigue, sleep latency, total sleep time, patient-reported outcomes
MeSH terms: Adult, Arousal, Double-Blind Method, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Long-Term Care, Male, Middle Aged, Piperazines, Quality of Life, Social Adjustment, Wakefulness, Work Capacity Evaluation, Azabicyclo Compounds

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Nightly Treatment of Primary Insomnia With Eszopiclone for Six Months: Effect on Sleep, Quality of Life, and Work Limitations

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