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