Trial Outcomes & Findings for Efficacy of Suvorexant on Post-operative Sleep Disturbance (NCT NCT05823844)
NCT ID: NCT05823844
Last Updated: 2026-07-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Day 0 of in-hospital stay after surgery
Results posted on
2026-07-23
Participant Flow
The power analysis suggested a total enrollment of 92 subjects. Due to technical difficulties with the Sleep Profiler, the N was increased to maintain adequate statistical power.
All the patients enrolled started the study.
Participant milestones
| Measure |
Suvorexant Administration
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
Placebo Administration
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Suvorexant Administration
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
Placebo Administration
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Suvorexant Administration
n=50 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=50 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 7.911 • n=50 Participants
|
65.4 years
STANDARD_DEVIATION 8.605 • n=50 Participants
|
66.1 years
STANDARD_DEVIATION 8.256 • n=100 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
52 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
48 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
28.4 kg/m^2
STANDARD_DEVIATION 4.562 • n=50 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 5.602 • n=50 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 5.191 • n=100 Participants
|
|
Charlson Comorbidity Score
|
3.3 Index
STANDARD_DEVIATION 1.921 • n=50 Participants
|
2.8 Index
STANDARD_DEVIATION 1.591 • n=50 Participants
|
3.09 Index
STANDARD_DEVIATION 1.770 • n=100 Participants
|
|
Insomnia Severity Score (pre-hospitalization)
|
16.3 Score
STANDARD_DEVIATION 5.456 • n=50 Participants
|
16.5 Score
STANDARD_DEVIATION 5.559 • n=50 Participants
|
16.4 Score
STANDARD_DEVIATION 5.481 • n=100 Participants
|
|
STOP BANG score
|
2.7 Score
STANDARD_DEVIATION 1.415 • n=50 Participants
|
2.6 Score
STANDARD_DEVIATION 1.206 • n=50 Participants
|
2.69 Score
STANDARD_DEVIATION 1.308 • n=100 Participants
|
|
RASS score
|
-0.4 Score
STANDARD_DEVIATION 0.659 • n=50 Participants
|
-0.6 Score
STANDARD_DEVIATION 0.837 • n=50 Participants
|
-0.532 Score
STANDARD_DEVIATION 0.758 • n=100 Participants
|
|
Time of end of the surgery
After 5pm
|
27 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
55 Participants
n=100 Participants
|
|
Time of end of the surgery
Before 5pm
|
23 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
45 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Day 0 of in-hospital stay after surgeryPopulation: Although 50 participants were included in each group, not all contributed data for all four postoperative days. Some patients were not assessed on night 1 due to late surgical completion. For subsequent days, analyses included only participants who remained hospitalized; those with shorter stays contributed data only for the days they were present.
Outcome measures
| Measure |
Suvorexant Administration
n=34 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=41 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Total Sleep Time on Day 0 (TST)
|
4.3 Total Sleep Time (Hours)
Standard Deviation 2.287
|
4.3 Total Sleep Time (Hours)
Standard Deviation 2.327
|
SECONDARY outcome
Timeframe: Up to Day 4 post-surgeryThe longitudinal trend of TST over the four days will be measured using mixed-effect regression. Group, time (day 0-4), and group x time will be included as the fixed effects and a random intercept of subjects to account for within-subject correlation due to repeated measurement. Regression estimates will be reported.
Outcome measures
| Measure |
Suvorexant Administration
n=46 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=39 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Longitudinal Trend of TST
|
4.55 Total Sleep Time (Hours)
Standard Deviation 2.09
|
4.33 Total Sleep Time (Hours)
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Up to Day 4 post-surgeryThe rate of attrition over the 4 days will be measured. If any specific patterns are identified, inverse propensity treatment weighting will be performed to adjust the effect of nonrandom dropout.
Outcome measures
| Measure |
Suvorexant Administration
n=50 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=50 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Rate of Attrition
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Day 4 post-surgeryPopulation: Although 50 participants were included in each group, not all contributed data for all four postoperative days. Some patients were not assessed on night 1 due to late surgical completion. For subsequent days, analyses included only participants who remained hospitalized; those with shorter stays contributed data only for the days they were present.
The Richards Campbell self-report sleep scale will be used to determine the quality of sleep each morning. This five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality. For each item, respondents are given a visual analogue scale and are asked to place a mark on the line indicating where their own experiences fit between two extremes (for example, the degree to which they received a "good night's sleep" or "a bad night's sleep"). Scale lines extend from 0 to 100 mm, and scores are calculated by measuring where responses fall on each line. A total score is obtained by summing each score out of 100 and dividing the total by five. Lower scores indicate a poorer quality of sleep (worse outcome).
Outcome measures
| Measure |
Suvorexant Administration
n=50 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=50 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Richards Campbell Self-Report Sleep Scale
Night 1
|
45.53 Score
Standard Deviation 37.73
|
38.74 Score
Standard Deviation 28.08
|
|
Richards Campbell Self-Report Sleep Scale
Night 2
|
52.0 Score
Standard Deviation 31.092
|
60.6 Score
Standard Deviation 32.107
|
|
Richards Campbell Self-Report Sleep Scale
Night 3
|
56.0 Score
Standard Deviation 28.727
|
54.2 Score
Standard Deviation 30.058
|
|
Richards Campbell Self-Report Sleep Scale
Night 4
|
48.8 Score
Standard Deviation 41.890
|
64.1 Score
Standard Deviation 18.195
|
SECONDARY outcome
Timeframe: Up to Day 4 post-surgeryPopulation: Although 50 participants were included in each group, not all contributed data for all four postoperative days. Some patients were not assessed on night 1 due to late surgical completion. For subsequent days, analyses included only participants who remained hospitalized; those with shorter stays contributed data only for the days they were present.
The 3-minute diagnostic interview for Confusion Assessment Method (CAM)-defined delirium (3D-CAM) is a brief verbal assessment tool that can be used to test for delirium. For all items, if the subject's answer is 'incorrect', 'yes', 'don't know', 'no response', or 'non-sensical response', then the appropriate (unshaded) column on the right side is checked. Each of the 4 columns designates a CAM feature. If any one box in a column is checked, the feature is considered present. The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.
Outcome measures
| Measure |
Suvorexant Administration
n=50 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=50 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Number of Participants With Incidence of Delirium
Delirium present Night POD 2
|
3 Participants
|
3 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present morning post operative day (POD) 1
|
8 Participants
|
6 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present Night POD 1
|
3 Participants
|
2 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present Morning POD 2
|
4 Participants
|
6 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present Morning POD 3
|
2 Participants
|
3 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present Night POD 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Incidence of Delirium
Delirium present Morning POD 4
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment to end of hospital stayNumber of rescue medication divided by the nummber of days stayed. Given the fact that sleep medication is taken only once, this outcome measures the sleep rescue medications per day
Outcome measures
| Measure |
Suvorexant Administration
n=50 Participants
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
Placebo Administration
n=49 Participants
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
|
|---|---|---|
|
Sleep Rescue Medication
|
0.162 Rescue Medications per day
Standard Deviation 0.335
|
0.153 Rescue Medications per day
Standard Deviation 0.318
|
Adverse Events
Suvorexant Administration
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Placebo Administration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant Administration
n=50 participants at risk
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
Placebo Administration
n=50 participants at risk
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
|---|---|---|
|
General disorders
Addmision to the ICU
|
2.0%
1/50 • From enrollment until the end of active participation in the study (taking the study pill), an average of 3-4 days, with a maximum of 4 days.
|
0.00%
0/50 • From enrollment until the end of active participation in the study (taking the study pill), an average of 3-4 days, with a maximum of 4 days.
|
Other adverse events
| Measure |
Suvorexant Administration
n=50 participants at risk
Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
Placebo Administration
n=50 participants at risk
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Face twitching
|
2.0%
1/50 • From enrollment until the end of active participation in the study (taking the study pill), an average of 3-4 days, with a maximum of 4 days.
|
0.00%
0/50 • From enrollment until the end of active participation in the study (taking the study pill), an average of 3-4 days, with a maximum of 4 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place