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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treating Insomnia and Improving Glycemic Control in Midlife Women With Insomnia and Pre-diabetes

Conditions
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Insomnia, Diabetes, Menopause

Intervention / Treatment
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* Drug: Suvorexant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suvorexant<br>20mg taken at bedtime for 4 weeks | Drug: Suvorexant<br>* 20mg taken at bedtime for 4 weeks<br>* Other names: Belsomra;|
| Placebo Comparator: placebo<br>placebo taken at bedtime for 4 weeks | Drug: Placebo<br>* placebo taken at bedtime for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index Score | 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 to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose | 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. | baseline to 4 weeks |