Trial Outcomes & Findings for Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia (NCT NCT03034018)
NCT ID: NCT03034018
Last Updated: 2022-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2022-03-14
Participant Flow
Participant milestones
| Measure |
Suvorexant
suvorexant 10-20 mg taken at bedtime for four weeks
|
Placebo
placebo taken at bedtime for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Initiated Assigned Treatment
|
27
|
29
|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Baseline characteristics by cohort
| Measure |
Suvorexant
n=27 Participants
suvorexant 10-20 mg taken at bedtime for four weeks
|
Placebo
n=29 Participants
placebo taken at bedtime for four weeks
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksPopulation: Participants who initiated treatment
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.
Outcome measures
| Measure |
Suvorexant
n=27 Participants
suvorexant 10-20 mg taken at bedtime for four weeks
|
Placebo
n=29 Participants
placebo taken at bedtime for four weeks
|
|---|---|---|
|
Within-person Change in ISI Score
|
-8.1 score on a scale
Interval -10.2 to -6.0
|
-5.6 score on a scale
Interval -7.4 to -3.9
|
Adverse Events
Suvorexant
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=27 participants at risk
suvorexant 10-20 mg taken at bedtime for four weeks
|
Placebo
n=29 participants at risk
placebo taken at bedtime for four weeks
|
|---|---|---|
|
General disorders
somnolence
|
14.8%
4/27 • Number of events 4 • 4 weeks
|
3.4%
1/29 • Number of events 1 • 4 weeks
|
|
General disorders
dry mouth
|
11.1%
3/27 • Number of events 3 • 4 weeks
|
6.9%
2/29 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
gastro-intestinal symptoms
|
7.4%
2/27 • Number of events 2 • 4 weeks
|
3.4%
1/29 • Number of events 1 • 4 weeks
|
|
Psychiatric disorders
mood symptoms
|
7.4%
2/27 • Number of events 2 • 4 weeks
|
3.4%
1/29 • Number of events 1 • 4 weeks
|
|
General disorders
headache
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
6.9%
2/29 • Number of events 2 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place