Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes
Purpose
The aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.
Conditions
- Insomnia
- Diabetes
- Menopause
Eligibility
- Eligible Ages
- Between 40 Years and 65 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental suvorexant |
20mg taken at bedtime for 4 weeks |
|
|
Placebo Comparator placebo |
placebo taken at bedtime for 4 weeks |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02115
Aleta Wiley, MPH
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.