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Nightly Treatment of Primary Insomnia With Eszopiclone for Six Months: Effect on Sleep, Quality of Life, and Work Limitations
Open accessAbstract
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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“In comparison with pharmacological therapies, in a study of the hypnotic eszopiclone over a 1-6 month period there was a 15 point increase in vitality [45].”
From Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia (2010) · cites this paper as [45]
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Metadata
- 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.
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2007-08
- Volume
- 30
- Issue
- 8
- Pages
- 959-968
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- 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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