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

• Status: Completed
• Trial end date: 2020-04-03
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Suvorexant

Criteria

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