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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03034018
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: suvorexant; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 25, 2017
• Actual Primary Completion Date: Apr 3, 2020
• Actual Study Completion Date: Apr 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: suvorexant suvorexant 10-20 mg taken at bedtime for four weeks	Drug: suvorexant; 10-20 mg taken at bedtime for four weeks; Other Names: Belsomra
Placebo Comparator: placebo placebo taken at bedtime for four weeks	Drug: placebo; placebo taken at bedtime for four weeks

Outcome Measures

Primary Outcome Measures

1. Within-person Change in ISI Score [baseline and 4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Hadine Joffe, MD MSc, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 9, 2021

More Information

Publications

None provided.

• Responsible Party: Hadine Joffe, MD MSc, Executive Director, Connors Center for Women's Health and Gender Biology, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03034018
• Other Study ID Numbers: 2016P002667
• First Posted: Jan 27, 2017
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hadine Joffe, MD MSc, Executive Director, Connors Center for Women's Health and Gender Biology, Brigham and Women's Hospital: insomnia; hot flashes; menopause; suvorexant; belsomra
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes; Suvorexant

Study Results

Participant Flow

Arm/Group Title	Suvorexant	Placebo
Arm/Group Description	suvorexant 10-20 mg taken at bedtime for four weeks	placebo taken at bedtime for four weeks
Period Title: Overall Study
STARTED	30	30
Initiated Assigned Treatment	27	29
COMPLETED	25	28
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Suvorexant	Placebo	Total
Arm/Group Description	suvorexant 10-20 mg taken at bedtime for four weeks	placebo taken at bedtime for four weeks	Total of all reporting groups
Overall Participants	27	29	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	27 100%	29 100%	56 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (4.5)	53.4 (3.9)	54.3 (4.3)
Sex: Female, Male (Count of Participants)
Female	27 100%	29 100%	56 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.7%	2 6.9%	3 5.4%
Not Hispanic or Latino	24 88.9%	23 79.3%	47 83.9%
Unknown or Not Reported	2 7.4%	4 13.8%	6 10.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	4 13.8%	4 7.1%
White	25 92.6%	20 69%	45 80.4%
More than one race	1 3.7%	1 3.4%	2 3.6%
Unknown or Not Reported	1 3.7%	4 13.8%	5 8.9%
Region of Enrollment (participants) [Number]
United States	27 100%	29 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Within-person Change in ISI Score
Description	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.
Time Frame	baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Participants who initiated treatment

Arm/Group Title	Suvorexant	Placebo
Arm/Group Description	suvorexant 10-20 mg taken at bedtime for four weeks	placebo taken at bedtime for four weeks
Measure Participants	27	29
Mean (95% Confidence Interval) [score on a scale]	-8.1	-5.6

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Suvorexant		Placebo
Arm/Group Description	suvorexant 10-20 mg taken at bedtime for four weeks		placebo taken at bedtime for four weeks
All Cause Mortality
	Suvorexant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)
Serious Adverse Events
	Suvorexant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Suvorexant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/27 (37%)		6/29 (20.7%)
Gastrointestinal disorders
gastro-intestinal symptoms	2/27 (7.4%)	2	1/29 (3.4%)	1
General disorders
somnolence	4/27 (14.8%)	4	1/29 (3.4%)	1
dry mouth	3/27 (11.1%)	3	2/29 (6.9%)	2
headache	1/27 (3.7%)	1	2/29 (6.9%)	2
Psychiatric disorders
mood symptoms	2/27 (7.4%)	2	1/29 (3.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.