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

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.

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

Conditions3

Locations1 site

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