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

Mass General Brigham

Status and phase: Enrolling; Phase 4

Conditions: Diabetes; Menopause; Insomnia

Treatments: Drug: Suvorexant; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05593653

2022P000768

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

suvorexant

Experimental group

Description:

20mg taken at bedtime for 4 weeks

Treatment:

Drug: Suvorexant

placebo

Placebo Comparator group

Description:

placebo taken at bedtime for 4 weeks

Treatment:

Drug: Placebo