Eszopiclone in Patients With Insomnia During Perimenopause and Early Postmenopause: A Randomized Controlled Trial
Abstract
OBJECTIVE: To evaluate eszopiclone 3 mg for treatment of insomnia in perimenopausal and early postmenopausal women, as well as the impact of insomnia treatment on mood, menopause-related symptoms, and quality of life. METHODS: This was a double-blind, placebo-controlled study with 410 women (aged 40-60; perimenopausal or early postmenopausal) who reported insomnia defined as sleep latency of at least 45 minutes and total sleep time less than or equal to 6 hours per night for at least 3 nights per week over the previous month. Patients were randomly assigned to eszopiclone 3 mg or placebo nightly for 4 weeks. Sleep data were collected once a day. Physician global assessments of menopause, menopause-specific questionnaire, Greene Climacteric Scale, the Montgomery Asberg Depression Rating Scale, and the Sheehan Disability Scale were collected at baseline and end of treatment. RESULTS: Patients receiving eszopiclone reported improvements in sleep induction, sleep maintenance, sleep duration, sleep quality, and next-day functioning relative to placebo (P<.05). Patients receiving eszopiclone reported fewer total awakenings and awakenings due to hot flushes (P<.05). Eszopiclone use led to greater improvement in Montgomery Asberg Depression Rating Scale scores (P<.05) and physician global assessments of menopause scores (P<.001); total Greene Climacteric Scale score and the vasomotor and psychological sub-scores (P<.05); vasomotor and physical domains of the menopause-specific questionnaire (P<.05); and family life/home domain of the Sheehan Disability Scale (P<.05). CONCLUSION: In this study, eszopiclone provided significant improvements in sleep and positively impacted mood, quality of life, and menopause-related symptoms in perimenopausal and early postmenopausal women with insomnia. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT00366093 LEVEL OF EVIDENCE: I.
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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 [129]
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- Authors
- Soares, C. N., Joffe, H., Rubens, R., Caron, J., Roth, T., & Cohen, L.
- Affiliations
- Harvard University (US)
- Sunovion (United States) (US)
- Henry Ford Health (US)
- Venue
- Obstetrics & Gynecology
- Published
- 2006-12
- Volume
- 108
- Issue
- 6
- Pages
- 1402-1410
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2324394935
- Cited by
- 135
- References
- 26
- Citations by year
- 2026: 5 · 2025: 2 · 2023: 3 · 2022: 2 · 2021: 8 · 2020: 6 · 2019: 5 · 2018: 4 · 2017: 3 · 2016: 9 · 2015: 2 · 2014: 9 · 2013: 16 · 2012: 7
- FWCI
- 13.40
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Keywords
- eszopiclone, insomnia, perimenopause, early postmenopause, menopausal symptoms, hot flashes, sleep quality, mood, depression, quality of life, sleep latency, sleep maintenance, sleep duration, sleep awakenings
- MeSH terms
- Affect, Double-Blind Method, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Middle Aged, Piperazines, Quality of Life, Sleep, Postmenopause, Hot Flashes, Perimenopause, Azabicyclo Compounds
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