Trial Outcomes & Findings for Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia (NCT NCT05593653)
NCT ID: NCT05593653
Last Updated: 2026-04-16
Results Overview
The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
baseline and end of each four-week intervention
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Suvorexant, Then Placebo
Participants first received suvorexant tablet (20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks.
|
Placebo, Then Suvorexant
Participants first received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received suvorexant tablet (20mg) daily at bedtime for 4 weeks.
|
|---|---|---|
|
First Intervention (4 weeks)
STARTED
|
15
|
16
|
|
First Intervention (4 weeks)
Received Intervention
|
13
|
16
|
|
First Intervention (4 weeks)
COMPLETED
|
13
|
16
|
|
First Intervention (4 weeks)
NOT COMPLETED
|
2
|
0
|
|
Washout Period (4 weeks)
STARTED
|
13
|
16
|
|
Washout Period (4 weeks)
COMPLETED
|
13
|
14
|
|
Washout Period (4 weeks)
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
13
|
14
|
|
Second Intervention
COMPLETED
|
13
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Suvorexant, Then Placebo
Participants first received suvorexant tablet (20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks.
|
Placebo, Then Suvorexant
Participants first received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received suvorexant tablet (20mg) daily at bedtime for 4 weeks.
|
|---|---|---|
|
First Intervention (4 weeks)
Withdrawal by Subject
|
1
|
0
|
|
First Intervention (4 weeks)
Became ineligible
|
1
|
0
|
|
Washout Period (4 weeks)
Withdrawn
|
0
|
2
|
Baseline Characteristics
Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
Baseline characteristics by cohort
| Measure |
Suvorexant, Then Placebo
n=13 Participants
Participants first received suvorexant tablet (20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks.
|
Placebo, Then Suvorexant
n=16 Participants
Participants first received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received suvorexant tablet (20mg) daily at bedtime for 4 weeks.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 4.3 • n=193 Participants
|
53.6 years
STANDARD_DEVIATION 4.9 • n=193 Participants
|
54.4 years
STANDARD_DEVIATION 4.7 • n=386 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=193 Participants
|
16 Participants
n=193 Participants
|
29 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
28 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: baseline and end of each four-week interventionThe Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
Outcome measures
| Measure |
Suvorexant
n=27 Participants
Participants who received suvorexant tablet (20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
Placebo
n=29 Participants
Participants who received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
|---|---|---|
|
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
ISI at Baseline
|
14.6 units on a scale
Standard Deviation 3.9
|
14.5 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
Change from Baseline at 4 weeks
|
-5.8 units on a scale
Standard Deviation 4.9
|
-2.7 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: baseline and end of each four-week interventionFasting glucose concentrations are determined from a blood sample collected at least 8 hours since last food intake.
Outcome measures
| Measure |
Suvorexant
n=27 Participants
Participants who received suvorexant tablet (20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
Placebo
n=29 Participants
Participants who received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose Concentrations at 4 Weeks
Fasting Plasma Glucose at Baseline
|
90.0 mg/dL
Standard Deviation 8.0
|
90.8 mg/dL
Standard Deviation 7.9
|
|
Change From Baseline in Fasting Glucose Concentrations at 4 Weeks
Change from Baseline at 4 weeks
|
2.1 mg/dL
Standard Deviation 7.4
|
-0.1 mg/dL
Standard Deviation 10.0
|
Adverse Events
Suvorexant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=27 participants at risk
Participants who received suvorexant tablet (20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
Placebo
n=29 participants at risk
Participants who received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study.
|
|---|---|---|
|
Psychiatric disorders
mood symptoms
|
0.00%
0/27 • Four weeks for each intervention
|
6.9%
2/29 • Number of events 2 • Four weeks for each intervention
|
|
Nervous system disorders
headache
|
3.7%
1/27 • Number of events 1 • Four weeks for each intervention
|
3.4%
1/29 • Number of events 1 • Four weeks for each intervention
|
|
Musculoskeletal and connective tissue disorders
arthritic discomfort
|
0.00%
0/27 • Four weeks for each intervention
|
3.4%
1/29 • Number of events 1 • Four weeks for each intervention
|
|
Skin and subcutaneous tissue disorders
skin irritation from continuous glucose monitor
|
0.00%
0/27 • Four weeks for each intervention
|
3.4%
1/29 • Number of events 1 • Four weeks for each intervention
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/27 • Four weeks for each intervention
|
3.4%
1/29 • Number of events 1 • Four weeks for each intervention
|
|
General disorders
malaise
|
3.7%
1/27 • Number of events 1 • Four weeks for each intervention
|
0.00%
0/29 • Four weeks for each intervention
|
|
Nervous system disorders
somnolence
|
3.7%
1/27 • Number of events 1 • Four weeks for each intervention
|
0.00%
0/29 • Four weeks for each intervention
|
|
Eye disorders
uveitis
|
3.7%
1/27 • Number of events 1 • Four weeks for each intervention
|
0.00%
0/29 • Four weeks for each intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place