Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes

Eligibility Criteria

• * Healthy women aged 40-65 years
• * Postmenopausal or late perimenopausal
• * Meets criteria for Insomnia Disorder
• * Score on the Insomnia Severity Index (ISI) measure ≥15
• * Subjective and sustained sleep disruption during screening
• * Hot flashes present, including at night
• * Pre-diabetic per guidelines from the American Diabetes Association
• * Diagnosis of other primary sleep disorders
• * Shift worker
• * Frequent use of hypnotic medications
• * Unwillingness to refrain from taking any sleep medications during the study period
• * Current major depressive episode
• * Suicidal ideation
• * Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
• * Current alcohol/substance use disorder
• * Current or prior diagnosis of diabetes mellitus
• * Use of an insulin sensitizer or a pharmacologic treatment for pre-diabetes
• * Extreme obesity
• * Current use of systemic hormonal therapies
• * 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 travel across time zones
• * Excessive coffee or cigarette use
• * Unwilling to limit alcohol, nicotine, and caffeine consumption during study