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

• Published in: Sleep (New York, N.Y.) Vol. 38; no. 1; pp. 97 - 108
• Main Authors: Ensrud, Kristine E, Guthrie, Katherine A, Hohensee, Chancellor, Caan, Bette, Carpenter, Janet S, Freeman, Ellen W, LaCroix, Andrea Z, Landis, Carol A, Manson, JoAnn, Newton, Katherine M, Otte, Julie, Reed, Susan D, Shifren, Jan L, Sternfeld, Barbara, Woods, Nancy F, Joffe, Hadine
• Format: Journal Article
• Language: English
• Published: United States Associated Professional Sleep Societies, LLC 01.01.2015
• Subjects: Cyclohexanols - administration & dosage; Cyclohexanols - pharmacology; Cyclohexanols - therapeutic use; Double-Blind Method; Effects of Estradiol and Venlafaxine on Insomnia in Women with Hot Flashes; Estradiol - administration & dosage; Estradiol - pharmacology; Estradiol - therapeutic use; Estrogens - administration & dosage; Estrogens - pharmacology; Estrogens - therapeutic use; Female; Hot Flashes - complications; Hot Flashes - physiopathology; Humans; Menopause - drug effects; Menopause - physiology; Middle Aged; Perimenopause - drug effects; Perimenopause - physiology; Sleep - drug effects; Sleep - physiology; Sleep Initiation and Maintenance Disorders - complications; Sleep Initiation and Maintenance Disorders - drug therapy; Sleep Initiation and Maintenance Disorders - physiopathology; Venlafaxine Hydrochloride; sleep; venlafaxine; menopause; randomized trial; hot flashes; estradiol
• ISSN: 0161-8105; 1550-9109
• DOI: 10.5665/sleep.4332

Determine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes. 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. Academic research centers. 339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day. 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). 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. NCT01418209 at www.clinicaltrials.gov.