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

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