Objective: The aim of this study was to determine the effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes.
Methods: A randomized, blinded, multicenter, placebo-controlled parallel-group 8-week trial with 205 women (95 African American, 102 white, 8 other) was conducted between July 2009 and June 2010. The participants received escitalopram (10-20 mg/d) or placebo. Insomnia symptoms (Insomnia Severity Index [ISI]) and subjective sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at weeks 4 and 8 were the prespecified secondary outcomes. A total of 199 women (97%) provided ISI data, and 194 (95%) women provided PSQI data at follow-up.
Results: At baseline, mean hot flash frequency was 9.78 per day (SD, 5.60), mean ISI was 11.4 (SD, 6.3), and mean PSQI was 8.0 (SD, 3.7). Treatment with escitalopram reduced ISI at week 8 (mean difference, −2.00; 95% CI, −3.43 to −0.57; P < 0.001 overall treatment effect), with mean differences of −4.73 (95% CI, −5.72 to −3.75) in the escitalopram group and −2.73 (95% CI, −3.78 to −1.69) in the placebo group. The reduction in PSQI was greater in the escitalopram than in the placebo group at week 8 (mean difference, −1.31; 95% CI, −2.14 to −0.49; P < 0.001 overall treatment effect). Clinical improvement in insomnia symptoms and subjective sleep quality (≥50% decreases in ISI and PSQI from baseline) was observed more frequently in the escitalopram group than in the placebo group (ISI, 50.0% vs 35.4%, P = 0.04; PSQI, 29.6% vs 19.2%, P = 0.09).
Conclusions: Among healthy perimenopausal and postmenopausal women with hot flashes, escitalopram at 10 to 20 mg/day compared with placebo reduced insomnia symptoms and improved subjective sleep quality at 8 weeks of follow-up.
From the 1Department of Medicine and Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN; 2Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN; 3Department of Psychiatry, Center for Women’s Mental Health, Massachusetts General Hospital, Boston, MA; 4Fred Hutchinson Cancer Research Center, Seattle, WA; 5Department of Medicine, University of Washington, Seattle, WA; 6Group Health Research Institute, Seattle. WA; 7Division of Research, Kaiser Permanente, Oakland, CA; 8Department of Biobehavioral Nursing and Health Systems, University of Washington, Seattle, WA; and 9Department of Obstetrics & Gynecology and Psychiatry, University of Pennsylvania, Philadelphia, PA.
Received October 14, 2011; revised and accepted December 19, 2011.
K.A.G. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy ofthe data analysis.All authors made substantial contributions to the study and this manuscript. None of the authors were compensated for manuscript preparation.
Funding/support: This study was supported by a cooperative agreement issued by the National Institute on Aging (NIA), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Complementary and Alternative Medicine, and the Office of Research on Women’s Health (U01 AG032656, U01AG032659, U01AG032669, U01AG032699, U01AG032700). At the University of Indiana site, the project was funded, in part, with support from the Indiana Clinical and Translational Sciences Institute, by Grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award. Escitalopram and matching placebo pills were provided by Forest Research Institute.
Financial disclosure/conflicts of interest: Dr. Joffe reports research support from Cephalon and advisory/consultant activities for Sunovion, Noven.
Trial registration: NCT00894543 at www.clinicaltrials.gov.
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Address correspondence to: Kristine E. Ensrud, MD, MPH, One Veterans Drive, General Internal Medicine (111-0), Minneapolis, MN 55417. E-mail: firstname.lastname@example.org