Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes

NCT ID: NCT05593653

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2025-12-31

Brief Summary

The aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.

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 who are pre-diabetic, and to learn whether improvement in insomnia symptoms is linked with improvement in blood sugar levels. 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). Primary data collection includes blood draws, monitoring glucose and lipid levels, actigraphy, questionnaires, and daily diaries.

Conditions

Insomnia; Diabetes; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

suvorexant

20mg taken at bedtime for 4 weeks

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

20mg taken at bedtime for 4 weeks

placebo

placebo taken at bedtime for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo taken at bedtime for 4 weeks

Interventions

Suvorexant

20mg taken at bedtime for 4 weeks

Intervention Type: DRUG

Placebo

placebo taken at bedtime for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Belsomra

Eligibility Criteria

Inclusion Criteria

• Healthy women aged 40-65 years
• Postmenopausal or late perimenopausal
• Meets criteria for Insomnia Disorder
• Score on the Insomnia Severity Index (ISI) measure ≥15
• Subjective and sustained sleep disruption during screening
• Hot flashes present, including at night
• Pre-diabetic per guidelines from the American Diabetes Association

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shadab A Rahman

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shadab Rahman, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aleta Wiley, MPH

Role: CONTACT

awiley1@bwh.harvard.edu

617-525-9627

Facility Contacts

Aleta Wiley, MPH

Role: primary

Other Identifiers

2022P000768

Identifier Type: -

Identifier Source: org_study_id