Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Menopause; Metabolic Health
• Intervention / Treatment: Drug: Suvorexant; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham And Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suvorexant; 20mg taken at bedtime for 4 weeks	Drug: Suvorexant; 20mg taken at bedtime for 4 weeks; Other Names: Belsomra
Placebo Comparator: placebo; placebo taken at bedtime for 4 weeks	Drug: Placebo; placebo taken at bedtime for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and end of each four-week intervention

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Shadab Rahman, PhD MPH, Brigham And Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Hypnotics and Sedatives; suvorexant
• Other Study ID Numbers: 2022P000768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes