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Question In perimenopausal or postmenopausal women with insomnia and hot flashes, what is the relative efficacy of telephone-based cognitive-behavioral therapy for insomnia (CBT-I) and telephone-based menopause education control (MEC) for reducing insomnia? Methods Design Randomized controlled trial (RCT). ClinicalTrials.gov NCT01936441. Allocation {Concealed}*.† Blinding Blinded† (data collectors). Follow-up period 24 weeks. Setting MsFlash research network in western Washington State, USA. Patients 106 perimenopausal and postmenopausal women 40 to 65 years of age (mean age 55 y) who had significant insomnia symptoms (Insomnia Severity Index [ISI] score ≥ 12) and ≥ 2 hot flashes/d for the past 2 weeks. Exclusion criteria included primary sleep disorder or major illness interfering with sleep, routine use of prescription sleep medication, consumption of > 3 alcoholic drinks/d, or shift work. Intervention CBT-I (n = 53) or MEC (n = 53), each of which comprised six 20- to 30-minute telephone sessions led by 2 female coaches over 8 weeks. CBT-I included information about age-related sleep changes, sleep hygiene, and stimulus control procedures; and teaching about cognitive techniques to reduce physiologic arousal and reduce unrealistic beliefs about sleep loss. Sleep windows were restricted to the average sleep time reported at baseline and extended by 15 minutes weekly when ≥ 85% sleep efficiency was achieved. MEC comprised general education and written information about women's health and quality of life, excluding information about CBT strategies for sleep. Outcomes Insomnia severity (ISI). Secondary outcome was Pittsburgh Sleep Quality Index (PSQI) score. Exploratory outcomes included no clinically significant insomnia {ISI}* and daily interference of hot flashes (Hot Flash Related Daily Interference Scale). Patient follow-up 83% at 8 weeks and 76% at 24 weeks (intention-to-treat analysis). Main results CBT-I reduced insomnia (on the ISI and PSQI) and increased the likelihood of no insomnia at 8 and 24 weeks compared with MEC (Table). CBT-I also reduced scores on the Hot Flash Related Daily Interference Scale at 8 (P = 0.03) and 24 (P = 0.003) weeks compared with MEC. Conclusion In perimenopausal or postmenopausal women with insomnia and hot flashes, telephone-based cognitive-behavioral therapy for insomnia reduced insomnia severity compared with telephone-based menopause education control. [ABSTRACT FROM AUTHOR]