What this trial studies
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.
Conditions in scope
- Insomnia
- Metabolic Health
- Menopause
Interventions
- Suvorexant (Drug) — 20mg taken at bedtime for 4 weeks
- Placebo (Drug) — placebo taken at bedtime for 4 weeks
Who can join
Women only · Ages 40 Years to 65 Years
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Boston | Massachusetts | Brigham and Women's Hospital | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: PHASE4
- Start date: 2023-01-06
- Primary completion: 2025-10-24
- Last update posted: 2026-04-16
- First posted: 2022-10-25
Sponsor & contact
Lead sponsor: Brigham and Women's Hospital (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks (baseline and end of each four-week intervention)
The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT05593653 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.