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Cited by 113Sleep and related disordersMenopause: Health Impacts and TreatmentsSleep and Work-Related Fatigue

Effect of zolpidem on sleep in women with perimenopausal and postmenopausal insomnia: a 4-week, randomized, multicenter, double-blind, placebo-controlled study

DORSEY, C, LEE, K, SCHARF, M·2004·Clinical Therapeutics
DOI 10.1016/j.clinthera.2004.10.003
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Abstract

Background Although most adults in the United States obtain less sleep than they need, women report more sleep deprivation throughout their lifetime than do men. The prevalence of self-reported sleep difficulty increases as women make the transition from the premenopausal to the postmenopausal period.Objective The purpose of this study was to assess the clinical efficacy and safety of zolpidem as a treatment for insomnia in perimenopausal and postmenopausal women.Methods Women who were perimenopausal or postmenopausal for >or=6 months, who had developed insomnia in conjunction with menopausal symptoms, and who had difficulty maintaining sleep or had nonrestorative sleep for >or=6 months were eligible for this 4-week, multicenter study. Sleep maintenance difficulty had to occur an average of >or=3 nights per week and had to be accompanied by >or=2 nocturnal hot flashes, hot flushes, or night sweats. Patients were randomized in a double-blind fashion to 1 of 2 treatment groups--zolpidem 10 mg or placebo. Capsules were provided in weekly blister cards, and patients were instructed to take 1 capsule each night at bedtime. Patients recorded estimates of their sleep quality and quantity and daytime functioning on daily morning and evening questionnaires, and made weekly global assessments of sleep.Results The study included 141 women (mean age +/- SD, 50.8 +/- 4.5 years; age range, 39-60 years). Increases in reported total sleep time were significantly greater in the zolpidem group than in the placebo group (P < 0.01) for each treatment week. Wake time after sleep onset and number of awakenings decreased significantly in the zolpidem group compared with the placebo group (P < 0.05). Each week, approximately twice as many patients in the zolpidem group as in the placebo group reported improved sleep (P < 0.001 for each week). The improvement in sleep-related difficulty with daytime functioning was significantly greater in the zolpidem group than in the placebo group (P < 0.05). The effects of zolpidem did not diminish with the duration of treatment.Conclusions Zolpidem 10 mg/d was effective and well tolerated in the treatment of menopause-related insomnia in perimenopausal and postmenopausal women.

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  • Zolpidem and eszopiclone have been shown to be more effective than placebo in the treatment of insomnia in the early stages of menopause.

    “although zolpidem and eszopiclone have been shown to be more effective than a placebo in the treatment of insomnia in the early stages of menopause [127-129]”

    From Non-Pharmacological Treatment of Insomnia (2012) · cites this paper as [127]

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Authors
DORSEY, C., LEE, K., & SCHARF, M.
Affiliations
  • Harvard University (US)
  • University of California, San Francisco (US)
Corresponding author
DORSEY, C
ORCID
DORSEY, C
Venue
Clinical Therapeutics
Publisher
Elsevier BV
Published
2004-10
Volume
26
Issue
10
Pages
1578-1586
ISSN
0149-2918 (ISSN-L)
DOI
10.1016/j.clinthera.2004.10.003
OpenAlex
W2014257408
Cited by
113
References
25
Citations by year
2026: 2 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 4 · 2020: 5 · 2019: 3 · 2018: 1 · 2017: 5 · 2016: 2 · 2015: 3 · 2014: 7 · 2013: 17 · 2012: 6
FWCI
8.45
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Clinical Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
Funders
Sanofi
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
Keywords
zolpidem, insomnia, menopause, perimenopause, postmenopause, sleep maintenance, non-restorative sleep, hot flashes, sleep quality, daytime functioning, hypnotic efficacy, drug safety
MeSH terms
Zolpidem, Adult, Double-Blind Method, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Middle Aged, Pyridines, Surveys and Questionnaires, Treatment Outcome, Postmenopause, Perimenopause

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