InsomniaPhase 4NCT05593653
Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
A Phase 4 study testing Suvorexant in people with Insomnia and Metabolic Health, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Insomnia, Metabolic Health, Menopause
- What is being tested?
- Suvorexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 24 Oct 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
The purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health. This is a double-blind, randomized placebo-controlled crossover trial. Study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period [Block 1], 4-week washout, and 4-week treatment period [Block 2]). During each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order).
- Conditions
- Insomnia, Metabolic Health, Menopause
- Being tested
- Suvorexant, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called Belsomra
20mg taken at bedtime for 4 weeks
PlaceboDrug
placebo taken at bedtime for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| suvorexant | Experimental | 20mg taken at bedtime for 4 weeks Receives: Drug: Suvorexant |
| placebo | Placebo comparator | placebo taken at bedtime for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
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.
Measured: baseline and end of each four-week intervention
Secondary outcomes (1)
Change From Baseline in Fasting Glucose Concentrations at 4 Weeks
Fasting glucose concentrations are determined from a blood sample collected at least 8 hours since last food intake.
Measured: baseline and end of each four-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start6 Jan 2023
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadab A Rahman, Brigham and Women's Hospital
- Investigators
- Shadab Rahman, PhD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593653
- Sponsor's protocol ID
- 2022P000768
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2022
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No