Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes

Kristine E. Ensrud, Katherine A. Guthrie, Chancellor Hohensee, Bette Caan, Janet S. Carpenter, Ellen W. Freeman, Andrea Z. LaCroix, Carol A. Landis, Jo Ann Manson, Katherine M. Newton, Julie Otte, Susan D. Reed, Jan L. Shifren, Barbara Sternfeld, Nancy F. Woods, Hadine Joffe

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Study Objectives: Determine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes.

Design: 3-arm double-blind randomized trial. Participants assigned in a 2:2:3 ratio to 17β estradiol 0.5 mg/day (n = 97), venlafaxine XR 75 mg/day (n = 96), or placebo (n = 146) for 8 weeks.

Setting: Academic research centers.

Participants: 339 community-dwelling perimenopausal and postmenopausal women with ≥ 2 bothersome hot flashes per day.

Measurements and Results: Insomnia symptoms (Insomnia Severity Index [ISI]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at baseline, week 4 and 8; 325 women (96%) provided ISI data and 312 women (92%) provided PSQI data at baseline and follow-up. At baseline, mean (SD) hot flash frequency was 8.1/day (5.3), mean ISI was 11.1 (6.0), and mean PSQI was 7.5 (3.4). Mean (95% CI) change from baseline in ISI at week 8 was-4.1 points (-5.3 to-3.0) with estradiol,-5.0 points (-6.1 to-3.9) with venlafaxine, and-3.0 points (-3.8 to-2.3) with placebo (P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine). Mean (95% CI) change from baseline in PSQI at week 8 was-2.2 points (-2.8 to-1.6) with estradiol,-2.3 points (-2.9 to-1.6) with venlafaxine, and-1.2 points (-1.7 to-0.8) with placebo (P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine).

Conclusions: Among perimenopausal and postmenopausal women with hot flashes, both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality.

Original languageEnglish (US)
Pages (from-to)97-108
Number of pages12
JournalSleep
Volume38
Issue number1
DOIs
StatePublished - Jan 1 2015

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Keywords

  • Estradiol
  • Hot flashes
  • Menopause
  • Randomized trial
  • Sleep
  • Venlafaxine

ASJC Scopus subject areas

  • Physiology (medical)
  • Clinical Neurology

Cite this

Ensrud, K. E., Guthrie, K. A., Hohensee, C., Caan, B., Carpenter, J. S., Freeman, E. W., LaCroix, A. Z., Landis, C. A., Manson, J. A., Newton, K. M., Otte, J., Reed, S. D., Shifren, J. L., Sternfeld, B., Woods, N. F., & Joffe, H. (2015). Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes. Sleep, 38(1), 97-108. https://doi.org/10.5665/sleep.4332