Phase 4
N=31
Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
Insomnia · Metabolic Health · Menopause
Bottom Line
View on ClinicalTrials.gov: NCT05593653 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks — 14.6; 14.5; -5.8; -2.7 units on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Suvorexant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Oct 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks |
14.6; 14.5; -5.8; -2.7 | 0.04 sig |
| SECONDARY Change From Baseline in Fasting Glucose Concentrations at 4 Weeks |
90.0; 90.8; 2.1; -0.1 | 0.33 |
Summary
The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.
Eligibility Criteria
Inclusion Criteria
- Healthy women aged 40-65 years
- Late perimenopausal or postmenopausal
- Meets criteria for Insomnia Disorder
- Elevated score on the Insomnia Severity Index (ISI) consistent with clinical insomnia
- Subjective and sustained sleep disruption during screening
- Hot flashes present, including at night
- Pre-diabetic per American Diabetes Association guidelines or have abnormal levels of one or more atherosclerotic cardiovascular disease risk factors per American Heart Association-defined metabolic syndrome
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
Data sourced from ClinicalTrials.gov (NCT05593653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.