Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women

The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

Inclusion Criteria:

• Peri- or postmenopausal women
• DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
• Some awakenings co-occur with a hot flash
• Score on the Insomnia Severity Index (ISI) measure ≥15
• Hot flashes present, including at night

Exclusion Criteria:

• Diagnosis of other primary sleep disorders
• Shift workers
• Current or expected use of hypnotic medications
• Current major depressive episode
• Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
• Current alcohol/substance use disorder
• Obesity
• Renal or hepatic disease
• Pregnancy or breastfeeding
• Recent malignancy
• Recent surgery
• Neurological disorder or cardiovascular disease raising safety concerns
• Medical instability considered to interfere with study procedures
• Concomitant medications with drug interaction or co-administration concerns
• Contraindications or allergic responses to suvorexant
• Recent or planned travel across time zones
• Excessive coffee or cigarette use