Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: suvorexant; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03034018

2016P002667

Details and patient eligibility

About

The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

Enrollment: 60 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peri- or postmenopausal women
• DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
• Some awakenings co-occur with a hot flash
• Score on the Insomnia Severity Index (ISI) measure ≥15
• Hot flashes present, including at night

Exclusion criteria

• Diagnosis of other primary sleep disorders
• Shift workers
• Current or expected use of hypnotic medications
• Current major depressive episode
• Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
• Current alcohol/substance use disorder
• Obesity
• 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 or planned travel across time zones
• Excessive coffee or cigarette use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

suvorexant

Experimental group

Description:

suvorexant 10-20 mg taken at bedtime for four weeks

Treatment:

Drug: suvorexant

placebo

Placebo Comparator group

Description:

placebo taken at bedtime for four weeks

Treatment:

Drug: placebo