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

Insomnia Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034018
• Other study ID #: 2016P002667
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2017
• Est. completion date: April 3, 2020

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• suvorexant
10-20 mg taken at bedtime for four weeks
• placebo
placebo taken at bedtime for four weeks

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-person Change in ISI Score	The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.	baseline and 4 weeks