title: Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes:  a randomized controlled trial.
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.
authors.affiliation: Department of Medicine and Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN, USA. ensru001@umn.edu
authors.forename: Kristine E
authors.initials: KE
authors.lastname: Ensrud
authors.forename: Hadine
authors.initials: H
authors.lastname: Joffe
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Guthrie
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Larson
authors.forename: Susan D
authors.initials: SD
authors.lastname: Reed
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Newton
authors.forename: Barbara
authors.initials: B
authors.lastname: Sternfeld
authors.forename: Andrea Z
authors.initials: AZ
authors.lastname: Lacroix
authors.forename: Carol A
authors.initials: CA
authors.lastname: Landis
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Woods
authors.forename: Ellen W
authors.initials: EW
authors.lastname: Freeman
mesh_terms: D000328:Adult; D001741:Black or African American; D015283:Citalopram / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D047648:Perimenopause; D010919:Placebos; D017698:Postmenopause; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D044465:White People
chemical_list: D015283:Citalopram; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors