Trial Outcomes & Findings for Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (NCT NCT00608985)
NCT ID: NCT00608985
Last Updated: 2016-03-14
Results Overview
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
709 participants
Primary outcome timeframe
From baseline to Day 1&2
Results posted on
2016-03-14
Participant Flow
First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009.
There was a screening period of 14 to 28 days. Two randomized subjects (one in each almorexant (ACT-078573) dose group) did not receive double-blind study treatment. The 'Started population' was defined as those participants who were randomized and treated.
Participant milestones
| Measure |
Placebo
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
177
|
186
|
176
|
168
|
|
Overall Study
Completed Double-blind Treatment
|
163
|
174
|
171
|
161
|
|
Overall Study
COMPLETED
|
161
|
173
|
170
|
159
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
6
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
7
|
4
|
6
|
|
Overall Study
Administrative/Other
|
7
|
4
|
1
|
2
|
|
Overall Study
Withdrawal of Consent
|
5
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Baseline characteristics by cohort
| Measure |
Placebo
n=177 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
Total
n=707 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
177 Participants
n=93 Participants
|
186 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
168 Participants
n=483 Participants
|
707 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 11.69 • n=93 Participants
|
44.1 years
STANDARD_DEVIATION 12.44 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 11.83 • n=27 Participants
|
45.1 years
STANDARD_DEVIATION 12.11 • n=483 Participants
|
45.4 years
STANDARD_DEVIATION 12.03 • n=36 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=93 Participants
|
113 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
106 Participants
n=483 Participants
|
436 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
271 Participants
n=36 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
12 participants
n=27 Participants
|
14 participants
n=483 Participants
|
54 participants
n=36 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
2 participants
n=27 Participants
|
4 participants
n=483 Participants
|
14 participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Region of Enrollment
Bulgaria
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Region of Enrollment
Czech Republic
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Region of Enrollment
Finland
|
13 participants
n=93 Participants
|
14 participants
n=4 Participants
|
13 participants
n=27 Participants
|
14 participants
n=483 Participants
|
54 participants
n=36 Participants
|
|
Region of Enrollment
France
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
2 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
83 participants
n=93 Participants
|
86 participants
n=4 Participants
|
87 participants
n=27 Participants
|
81 participants
n=483 Participants
|
337 participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
12 participants
n=93 Participants
|
11 participants
n=4 Participants
|
11 participants
n=27 Participants
|
13 participants
n=483 Participants
|
47 participants
n=36 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
5 participants
n=483 Participants
|
21 participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
3 participants
n=483 Participants
|
12 participants
n=36 Participants
|
|
Region of Enrollment
South Africa
|
15 participants
n=93 Participants
|
13 participants
n=4 Participants
|
13 participants
n=27 Participants
|
12 participants
n=483 Participants
|
53 participants
n=36 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
5 participants
n=27 Participants
|
3 participants
n=483 Participants
|
18 participants
n=36 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
5 participants
n=27 Participants
|
6 participants
n=483 Participants
|
25 participants
n=36 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
1 participants
n=483 Participants
|
10 participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
12 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 1&2Population: All treated patients
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Outcome measures
| Measure |
Placebo
n=177 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Baseline
|
85.0 minutes
95% Confidence Interval 39.81 • Interval 77.3 to 91.0
|
86.6 minutes
95% Confidence Interval 39.17 • Interval 80.0 to 92.3
|
92.3 minutes
95% Confidence Interval 35.92 • Interval 84.8 to 98.3
|
76.5 minutes
95% Confidence Interval 36.95 • Interval 69.3 to 82.0
|
|
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Day 1&2
|
72.8 minutes
95% Confidence Interval 42.63 • Interval 63.3 to 81.8
|
54.5 minutes
95% Confidence Interval 37.65 • Interval 47.3 to 61.0
|
46.4 minutes
95% Confidence Interval 28.85 • Interval 41.8 to 49.8
|
54.6 minutes
95% Confidence Interval 36.05 • Interval 49.0 to 62.5
|
|
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Change from baseline to day 1&2
|
-11.8 minutes
95% Confidence Interval 38.73 • Interval -19.3 to -7.3
|
-29.0 minutes
95% Confidence Interval 31.50 • Interval -33.0 to -23.3
|
-40.4 minutes
95% Confidence Interval 31.70 • Interval -47.5 to -31.5
|
-17.9 minutes
95% Confidence Interval 29.19 • Interval -25.3 to -12.0
|
PRIMARY outcome
Timeframe: From baseline to Day 15&16Population: All treated patients
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Outcome measures
| Measure |
Placebo
n=177 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Day 15&16 in WASO
Baseline
|
85.0 minutes
95% Confidence Interval 39.81 • Interval 77.3 to 91.0
|
86.6 minutes
95% Confidence Interval 39.17 • Interval 80.0 to 92.3
|
92.3 minutes
95% Confidence Interval 35.92 • Interval 84.8 to 98.3
|
76.5 minutes
95% Confidence Interval 36.95 • Interval 69.3 to 82.0
|
|
Change From Baseline to Day 15&16 in WASO
Day 15&16
|
65.0 minutes
95% Confidence Interval 45.90 • Interval 56.0 to 71.5
|
55.8 minutes
95% Confidence Interval 35.07 • Interval 50.5 to 59.0
|
51.8 minutes
95% Confidence Interval 31.31 • Interval 46.3 to 56.0
|
63.0 minutes
95% Confidence Interval 42.31 • Interval 56.5 to 72.5
|
|
Change From Baseline to Day 15&16 in WASO
Change from baseline to Day 15&16
|
-18.3 minutes
95% Confidence Interval 43.40 • Interval -22.0 to -12.0
|
-29.6 minutes
95% Confidence Interval 33.12 • Interval -33.5 to -23.8
|
-36.3 minutes
95% Confidence Interval 35.20 • Interval -43.8 to -26.5
|
-15.1 minutes
95% Confidence Interval 36.61 • Interval -19.0 to -8.8
|
PRIMARY outcome
Timeframe: From baseline to Week 1&2Population: All treated patients with available data
sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1\&2
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=179 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=173 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Baseline
|
64.0 minutes
95% Confidence Interval 51.32 • Interval 60.0 to 75.0
|
65.0 minutes
95% Confidence Interval 60.49 • Interval 59.5 to 72.0
|
69.0 minutes
95% Confidence Interval 46.68 • Interval 63.0 to 77.0
|
61.6 minutes
95% Confidence Interval 48.29 • Interval 55.0 to 70.9
|
|
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Week 1&2
|
52.9 minutes
95% Confidence Interval 48.33 • Interval 47.5 to 58.1
|
40.5 minutes
95% Confidence Interval 50.87 • Interval 34.5 to 48.3
|
42.9 minutes
95% Confidence Interval 42.06 • Interval 37.5 to 47.5
|
30.5 minutes
95% Confidence Interval 42.26 • Interval 25.9 to 39.6
|
|
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Change from baseline to week 1&2
|
-14.1 minutes
95% Confidence Interval 31.84 • Interval -20.0 to -9.2
|
-19.5 minutes
95% Confidence Interval 36.93 • Interval -22.9 to -12.7
|
-21.8 minutes
95% Confidence Interval 32.5 • Interval -28.8 to -17.5
|
-23.4 minutes
95% Confidence Interval 33.22 • Interval -27.5 to -19.0
|
SECONDARY outcome
Timeframe: From baseline to Day 1&2Population: All treated patients
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Outcome measures
| Measure |
Placebo
n=177 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Baseline
|
57.3 minutes
95% Confidence Interval 41.81 • Interval 53.0 to 65.5
|
57.4 minutes
95% Confidence Interval 37.03 • Interval 52.0 to 63.3
|
54.1 minutes
95% Confidence Interval 32.89 • Interval 47.5 to 58.3
|
56.5 minutes
95% Confidence Interval 34.60 • Interval 52.3 to 66.0
|
|
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Day 1&2
|
37.5 minutes
95% Confidence Interval 34.64 • Interval 32.3 to 44.0
|
28.8 minutes
95% Confidence Interval 30.13 • Interval 25.0 to 34.5
|
25.0 minutes
95% Confidence Interval 21.97 • Interval 22.3 to 28.3
|
22.5 minutes
95% Confidence Interval 27.25 • Interval 20.3 to 26.8
|
|
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Change from baseline to day 1&2
|
-15.8 minutes
95% Confidence Interval 40.21 • Interval -19.5 to -11.0
|
-24.8 minutes
95% Confidence Interval 37.00 • Interval -29.8 to -18.3
|
-22.5 minutes
95% Confidence Interval 30.83 • Interval -27.5 to -20.5
|
-29.4 minutes
95% Confidence Interval 34.63 • Interval -35.8 to -25.3
|
SECONDARY outcome
Timeframe: From baseline to Day 15&16Population: All treated patients
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Outcome measures
| Measure |
Placebo
n=177 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Day 15&16 in LPS
Baseline
|
57.3 minutes
95% Confidence Interval 41.81 • Interval 53.0 to 65.5
|
57.4 minutes
95% Confidence Interval 37.03 • Interval 52.0 to 63.3
|
54.1 minutes
95% Confidence Interval 32.89 • Interval 47.5 to 58.3
|
56.5 minutes
95% Confidence Interval 34.60 • Interval 52.3 to 66.0
|
|
Change From Baseline to Day 15&16 in LPS
Day 15&16
|
30.0 minutes
95% Confidence Interval 35.33 • Interval 26.0 to 37.8
|
29.3 minutes
95% Confidence Interval 28.51 • Interval 25.8 to 35.3
|
24.1 minutes
95% Confidence Interval 22.48 • Interval 21.5 to 28.0
|
24.6 minutes
95% Confidence Interval 25.62 • Interval 21.3 to 28.3
|
|
Change From Baseline to Day 15&16 in LPS
Change from baseline to day 15&16
|
-20.0 minutes
95% Confidence Interval 46.10 • Interval -25.8 to -16.3
|
-23.5 minutes
95% Confidence Interval 35.90 • Interval -31.0 to -20.0
|
-26.5 minutes
95% Confidence Interval 31.10 • Interval -30.8 to -22.8
|
-32.3 minutes
95% Confidence Interval 34.19 • Interval -36.0 to -26.0
|
SECONDARY outcome
Timeframe: From baseline to Week 1&2Population: All treated patients with available data
sLSO was the self-reported time to fall asleep as reported in the sleep diary
Outcome measures
| Measure |
Placebo
n=175 Participants
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=179 Participants
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=173 Participants
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 Participants
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Baseline
|
58.8 minutes
95% Confidence Interval 33.68 • Interval 52.0 to 64.5
|
55.0 minutes
95% Confidence Interval 50.70 • Interval 49.0 to 60.6
|
53.3 minutes
95% Confidence Interval 27.93 • Interval 50.5 to 58.4
|
50.5 minutes
95% Confidence Interval 29.34 • Interval 45.2 to 57.0
|
|
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Week 1&2
|
45.0 minutes
95% Confidence Interval 31.61 • Interval 39.2 to 51.0
|
36.5 minutes
95% Confidence Interval 40.64 • Interval 32.9 to 41.7
|
34.5 minutes
95% Confidence Interval 21.56 • Interval 31.5 to 38.3
|
33.3 minutes
95% Confidence Interval 21.50 • Interval 31.1 to 37.2
|
|
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Change from baseline to week 1&2
|
-10.0 minutes
95% Confidence Interval 26.89 • Interval -15.1 to -4.7
|
-16.2 minutes
95% Confidence Interval 34.48 • Interval -19.3 to -12.4
|
-16.2 minutes
95% Confidence Interval 23.22 • Interval -19.9 to -13.5
|
-17.2 minutes
95% Confidence Interval 25.67 • Interval -19.9 to -12.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Almorexant 100mg
Serious events: 2 serious events
Other events: 65 other events
Deaths: 0 deaths
Almorexant 200mg
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Zolpidem 10mg
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=177 participants at risk
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 participants at risk
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 participants at risk
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 participants at risk
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • Number of events 1 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • Number of events 1 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • Number of events 1 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
Other adverse events
| Measure |
Placebo
n=177 participants at risk
Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 100mg
n=186 participants at risk
almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
|
Almorexant 200mg
n=176 participants at risk
almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem
|
Zolpidem 10mg
n=168 participants at risk
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
11.9%
21/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
9.7%
18/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
14.8%
26/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
17.3%
29/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
General disorders
FATIGUE
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
4.8%
9/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.4%
6/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.6%
6/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
DIZZINESS
|
5.6%
10/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.2%
6/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
4.5%
8/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.8%
3/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
SOMNOLENCE
|
2.3%
4/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.2%
6/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.8%
5/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.4%
4/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
NAUSEA
|
4.0%
7/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.2%
4/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.4%
6/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.4%
4/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
General disorders
ASTHENIA
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.7%
5/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.7%
3/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.7%
3/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
2.7%
5/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.0%
5/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
3.2%
6/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.7%
3/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.6%
3/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.8%
3/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.7%
3/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
DYSGEUSIA
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.8%
3/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Nervous system disorders
PARAESTHESIA
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Psychiatric disorders
NIGHTMARE
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Cardiac disorders
PALPITATIONS
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
General disorders
CHEST DISCOMFORT
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Eye disorders
BLEPHAROSPASM
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Metabolism and nutrition disorders
FOOD CRAVING
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.1%
2/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.54%
1/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.8%
3/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Eye disorders
VISION BLURRED
|
1.7%
3/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.56%
1/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
1.2%
2/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.1%
2/177 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.00%
0/186 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.57%
1/176 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
0.60%
1/168 • All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
|
Additional Information
Ouali Berkani/Clinical Trial Leader
Actelion Pharmaceuticals Ltd
Phone: +41 61 565 5342
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER