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Can a sleep drug boost metabolic health in menopausal women?

NCT ID NCT05593653

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the sleep medication suvorexant (Belsomra) can reduce insomnia severity and improve metabolic health in midlife women who have both insomnia and signs of metabolic syndrome. Thirty-one healthy women aged 40-65 who were perimenopausal or postmenopausal took either suvorexant or a placebo for 4 weeks. Researchers measured changes in insomnia scores and fasting glucose levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Suvorexant (Belsomra)
What this could lead to
If it works, this could point toward a treatment that eases insomnia and improves metabolic health in midlife women.
What could go wrong
This is a small, completed Phase 4 trial with only 31 participants, so results may not apply widely. The drug may not significantly improve metabolic outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

31 people

The number who actually took part.

Started

Jan 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Menopause Metabolic health

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.