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Menopause:
doi: 10.1097/gme.0b013e3182476099
Original Articles

Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial

Ensrud, Kristine E. MD, MPH1,2; Joffe, Hadine MD, MSc3; Guthrie, Katherine A. PhD4; Larson, Joseph C. MS4; Reed, Susan D. MD, MPH5; Newton, Katherine M. PhD6; Sternfeld, Barbara PhD7; LaCroix, Andrea Z. PhD4; Landis, Carol A. DNSc, RN8; Woods, Nancy F. PhD, RN8; Freeman, Ellen W. PhD9

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Abstract

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.

©2012The North American Menopause Society

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