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

• Status: Not yet recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.

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

Details

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

Criteria

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 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