Eligible women were aged 40–62 years and in general good health in the menopause transition (amenorrhea ≥60 days in the past year), postmenopausal (≥12 months since last menstrual period or bilateral oophorectomy), or had undergone hysterectomy with 1 or more ovaries remaining and had follicle stimulating hormone level >20 mIU/mL and estradiol level ≤50 pg/mL and reported ≥28 hot flashes/night sweats per week (recorded on daily diaries for 3 weeks) rated as bothersome or severe on ≥4 days per week. All women provided written informed consent.īetween July 2009 and June 2010, the study enrolled 205 women. The protocol was approved by the appropriate institutional review board at each site. Self reported sleep measures (insomnia symptoms as assessed by the Insomnia Severity Index and subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index ) at 4 and 8 weeks were a priori specified secondary outcomes. The study design, methods and main trial results have been reported elsewhere.( 15) The primary objective of the trial was to determine the efficacy of escitalopram on self reported hot flash frequency and severity (7-day averages for both measures) at 4 and 8 weeks. The study was a double-blind, placebo-controlled randomized trial conducted at 4 MsFLASH network sites (see Appendix, Supplemental Digital Content 1, which lists funding sources, sites and investigators of the MsFLASH research network, ) with enrollment stratified by race (African American and White as self reported). We now report the effect of escitalopram versus placebo on insomnia symptoms and subjective sleep quality ( a priori specified secondary outcomes) and examine whether any observed effect varied across risk subgroup at baseline. As previously reported( 15), treatment with escitalopram compared with placebo resulted in fewer and less severe hot flashes at 8 weeks. We systematically collected validated, self-reported sleep measures in a randomized double-blind placebo-controlled trial designed primarily to evaluate the effect of the SSRI escitalopram on the frequency and severity of menopausal hot flashes. Hormone therapy (estrogen with or without progestin) remains the predominant and only FDA approved treatment for menopausal hot flashes, but use markedly decreased following the release of findings from the Women’s Health Initiative Estrogen Plus Progestin Trial that identified the delicate balance of risks versus benefits of combined hormone therapy.( 9 10) Increasingly prescribed to women in midlife( 11), selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs and SNRIs) have shown modest efficacy in reducing hot flash frequency and severity in prior randomized controlled trials, ( 12),( 13) but use of SSRIs/SNRIs for treatment of hot flashes is limited by concerns about commonly reported side effects, including insomnia and somnolence.( 4 14) However, it is also plausible that SSRIs/SNRIs may improve sleep in parallel with reducing hot flash frequency and severity. Prior cross-sectional studies have reported a graded association between hot flashes and insomnia symptoms( 5 6), though the exact role that hot flashes play in sleep complaints of menopausal women remains controversial.( 7 8) Self-reported sleep complaints are common in perimenopausal and postmenopausal women( 1– 3) and have been identified as a key symptom of the menopause transition.( 4) Menopause-related sleep disturbance has often been attributed at least in part to nocturnal hot flashes.
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