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

Inclusion 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

Exclusion Criteria:

• 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 healthproblem
• 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