Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia

NCT05593653 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022P000768
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Health; Insomnia; Menopause

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and end of each four-week intervention

Secondary Outcomes (1)

• Change From Baseline in Fasting Glucose Concentrations at 4 Weeks

  baseline and end of each four-week intervention

Study Arms (2)

suvorexant

EXPERIMENTAL

20mg taken at bedtime for 4 weeks

Drug: Suvorexant

placebo

PLACEBO COMPARATOR

placebo taken at bedtime for 4 weeks

Drug: Placebo

Interventions

Suvorexant DRUG

20mg taken at bedtime for 4 weeks

Also known as: Belsomra

suvorexant

Placebo DRUG

placebo taken at bedtime for 4 weeks

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Shadab Rahman, PhD MPH
• Organization: Brigham and Women's Hospital

sarahman@bwh.harvard.edu

617-732-4015

Study Officials

• Shadab Rahman, PhD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: January 6, 2023
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-03

Locations

US (1)