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

Phase 4

Recruiting

• Conditions: Insomnia; Diabetes; Menopause
• Interventions: Drug: Suvorexant; Drug: Placebo

• Registration Number: NCT05593653
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Study Start: 2023-01-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
suvorexant	Suvorexant	20mg taken at bedtime for 4 weeks
placebo	Placebo	placebo taken at bedtime for 4 weeks

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index Score	baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	baseline to 4 weeks	Fasting plasma glucose is determined from a blood sample collected at least 8 hours since last food intake. Range indications: 0-99 mg/dL is normal, 100-125 mg/dL is pre-diabetic, and 126 mg/dL+ indicates diabetes.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States