Primary Insomnia
Conditions
Keywords
sleeplessness, orexin receptor antagonist, almorexant, insomnia
Brief summary
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
Interventions
DRUGalmorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
DRUGPlacebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
DRUGzolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Sponsors
Midnight Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Adult subjects (18-64 years) with a diagnosis of primary insomnia.
Exclusion criteria
* History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia. * Sleep apnea, or restless legs syndrome. * Daytime napping of more than 1 hour per day. * Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit. * Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | From baseline to Day 1&2 | 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 |
| Change From Baseline to Day 15&16 in WASO | From baseline to Day 15&16 | 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 |
| Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | From baseline to Week 1&2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | From baseline to Day 1&2 | 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 |
| Change From Baseline to Day 15&16 in LPS | From baseline to Day 15&16 | 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 |
| Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | From baseline to Week 1&2 | sLSO was the self-reported time to fall asleep as reported in the sleep diary |
Countries
Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Participant flow
Recruitment details
First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | 177 |
| Almorexant 100mg almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | 186 |
| Almorexant 200mg almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | 176 |
| Zolpidem 10mg zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated | 168 |
| Total | 707 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative/Other | 7 | 4 | 1 | 2 |
| Overall Study | Adverse Event | 2 | 7 | 4 | 6 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 |
| Overall Study | Withdrawal of Consent | 5 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Almorexant 100mg | Almorexant 200mg | Zolpidem 10mg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 177 Participants | 186 Participants | 176 Participants | 168 Participants | 707 Participants |
| Age, Continuous | 46.2 years STANDARD_DEVIATION 11.69 | 44.1 years STANDARD_DEVIATION 12.44 | 46.1 years STANDARD_DEVIATION 11.83 | 45.1 years STANDARD_DEVIATION 12.11 | 45.4 years STANDARD_DEVIATION 12.03 |
| Region of Enrollment Australia | 13 participants | 15 participants | 12 participants | 14 participants | 54 participants |
| Region of Enrollment Austria | 3 participants | 5 participants | 2 participants | 4 participants | 14 participants |
| Region of Enrollment Belgium | 0 participants | 1 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment Bulgaria | 1 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment Czech Republic | 2 participants | 2 participants | 1 participants | 1 participants | 6 participants |
| Region of Enrollment Denmark | 6 participants | 5 participants | 5 participants | 4 participants | 20 participants |
| Region of Enrollment Finland | 13 participants | 14 participants | 13 participants | 14 participants | 54 participants |
| Region of Enrollment France | 3 participants | 2 participants | 3 participants | 2 participants | 10 participants |
| Region of Enrollment Germany | 83 participants | 86 participants | 87 participants | 81 participants | 337 participants |
| Region of Enrollment Hungary | 12 participants | 11 participants | 11 participants | 13 participants | 47 participants |
| Region of Enrollment Israel | 5 participants | 5 participants | 6 participants | 5 participants | 21 participants |
| Region of Enrollment Italy | 3 participants | 3 participants | 2 participants | 2 participants | 10 participants |
| Region of Enrollment Poland | 3 participants | 3 participants | 3 participants | 3 participants | 12 participants |
| Region of Enrollment South Africa | 15 participants | 13 participants | 13 participants | 12 participants | 53 participants |
| Region of Enrollment Spain | 4 participants | 6 participants | 5 participants | 3 participants | 18 participants |
| Region of Enrollment Sweden | 6 participants | 8 participants | 5 participants | 6 participants | 25 participants |
| Region of Enrollment Switzerland | 1 participants | 4 participants | 4 participants | 1 participants | 10 participants |
| Region of Enrollment United Kingdom | 4 participants | 3 participants | 2 participants | 3 participants | 12 participants |
| Sex: Female, Male Female | 111 Participants | 113 Participants | 106 Participants | 106 Participants | 436 Participants |
| Sex: Female, Male Male | 66 Participants | 73 Participants | 70 Participants | 62 Participants | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 64 / 177 | 65 / 186 | 61 / 176 | 72 / 168 |
| serious Total, serious adverse events | 0 / 177 | 2 / 186 | 1 / 176 | 0 / 168 |
Outcome results
Primary
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
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
Time frame: From baseline to Day 1&2
Population: All treated patients
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Baseline | 85.0 minutes | 95% Confidence Interval 39.81 |
| Placebo | 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 |
| Placebo | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Day 1&2 | 72.8 minutes | 95% Confidence Interval 42.63 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Baseline | 86.6 minutes | 95% Confidence Interval 39.17 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Change from baseline to day 1&2 | -29.0 minutes | 95% Confidence Interval 31.5 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Day 1&2 | 54.5 minutes | 95% Confidence Interval 37.65 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Day 1&2 | 46.4 minutes | 95% Confidence Interval 28.85 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Baseline | 92.3 minutes | 95% Confidence Interval 35.92 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Change from baseline to day 1&2 | -40.4 minutes | 95% Confidence Interval 31.7 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Baseline | 76.5 minutes | 95% Confidence Interval 36.95 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Change from baseline to day 1&2 | -17.9 minutes | 95% Confidence Interval 29.19 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | Day 1&2 | 54.6 minutes | 95% Confidence Interval 36.05 |
Comparison: Change from baseline to day 1\&2 compared with placebop-value: <0.000195% CI: [-21.8, -8.8]Wilcoxon rank-sum
Comparison: Change from baseline to day 1\&2 compared with placebop-value: <0.000195% CI: [-34.3, -19.5]Wilcoxon rank-sum
Comparison: Change from baseline to day 1\&2 compared with placebop-value: 0.037695% CI: [-13.5, -0.3]Wilcoxon rank-sum
Primary
Change From Baseline to Day 15&16 in WASO
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
Time frame: From baseline to Day 15&16
Population: All treated patients
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Day 15&16 in WASO | Baseline | 85.0 minutes | 95% Confidence Interval 39.81 |
| Placebo | Change From Baseline to Day 15&16 in WASO | Change from baseline to Day 15&16 | -18.3 minutes | 95% Confidence Interval 43.4 |
| Placebo | Change From Baseline to Day 15&16 in WASO | Day 15&16 | 65.0 minutes | 95% Confidence Interval 45.9 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in WASO | Baseline | 86.6 minutes | 95% Confidence Interval 39.17 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in WASO | Change from baseline to Day 15&16 | -29.6 minutes | 95% Confidence Interval 33.12 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in WASO | Day 15&16 | 55.8 minutes | 95% Confidence Interval 35.07 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in WASO | Day 15&16 | 51.8 minutes | 95% Confidence Interval 31.31 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in WASO | Baseline | 92.3 minutes | 95% Confidence Interval 35.92 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in WASO | Change from baseline to Day 15&16 | -36.3 minutes | 95% Confidence Interval 35.2 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in WASO | Baseline | 76.5 minutes | 95% Confidence Interval 36.95 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in WASO | Change from baseline to Day 15&16 | -15.1 minutes | 95% Confidence Interval 36.61 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in WASO | Day 15&16 | 63.0 minutes | 95% Confidence Interval 42.31 |
Comparison: Change from baseline to day 15\&16 compared with placebop-value: 0.000195% CI: [-20.3, -6.5]Wilcoxon rank-sum
Comparison: Change from baseline to day 15\&16 compared with placebop-value: <0.000195% CI: [-27.3, -12.3]Wilcoxon rank-sum
Comparison: Change from baseline to day 15\&16 compared with placebop-value: 0.335895% CI: [-3.8, 11]Wilcoxon rank-sum
Primary
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
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
Time frame: From baseline to Week 1&2
Population: All treated patients with available data
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Baseline | 64.0 minutes | 95% Confidence Interval 51.32 |
| Placebo | 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 |
| Placebo | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Week 1&2 | 52.9 minutes | 95% Confidence Interval 48.33 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Baseline | 65.0 minutes | 95% Confidence Interval 60.49 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Change from baseline to week 1&2 | -19.5 minutes | 95% Confidence Interval 36.93 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Week 1&2 | 40.5 minutes | 95% Confidence Interval 50.87 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Week 1&2 | 42.9 minutes | 95% Confidence Interval 42.06 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Baseline | 69.0 minutes | 95% Confidence Interval 46.68 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Change from baseline to week 1&2 | -21.8 minutes | 95% Confidence Interval 32.5 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Baseline | 61.6 minutes | 95% Confidence Interval 48.29 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Change from baseline to week 1&2 | -23.4 minutes | 95% Confidence Interval 33.22 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | Week 1&2 | 30.5 minutes | 95% Confidence Interval 42.26 |
Comparison: Change from baseline to week 1\&2 compared with placebop-value: 0.018695% CI: [-13.3, -1.3]Wilcoxon rank-sum
Comparison: Change from baseline to week 1\&2 compared with placebop-value: 0.000695% CI: [-16.4, -4.6]Wilcoxon rank-sum
Comparison: Change from baseline to week 1\&2 compared with placebop-value: <0.000195% CI: [-18.8, -6.6]Wilcoxon rank-sum
Secondary
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
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
Time frame: From baseline to Day 1&2
Population: All treated patients
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Baseline | 57.3 minutes | 95% Confidence Interval 41.81 |
| Placebo | 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 |
| Placebo | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Day 1&2 | 37.5 minutes | 95% Confidence Interval 34.64 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Baseline | 57.4 minutes | 95% Confidence Interval 37.03 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Change from baseline to day 1&2 | -24.8 minutes | 95% Confidence Interval 37 |
| Almorexant 100mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Day 1&2 | 28.8 minutes | 95% Confidence Interval 30.13 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Day 1&2 | 25.0 minutes | 95% Confidence Interval 21.97 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Baseline | 54.1 minutes | 95% Confidence Interval 32.89 |
| Almorexant 200mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Change from baseline to day 1&2 | -22.5 minutes | 95% Confidence Interval 30.83 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Baseline | 56.5 minutes | 95% Confidence Interval 34.6 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Change from baseline to day 1&2 | -29.4 minutes | 95% Confidence Interval 34.63 |
| Zolpidem 10mg | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | Day 1&2 | 22.5 minutes | 95% Confidence Interval 27.25 |
Comparison: Change from baseline to day 1\&2 compared with placebop-value: 0.000695% CI: [-15, -4.3]Wilcoxon rank-sum
Comparison: Change from baseline to day 1\&2 compared with placebop-value: 0.003595% CI: [-15.3, -3]Wilcoxon rank-sum
Comparison: Change from baseline to day 1\&2 compared with placebop-value: <0.000195% CI: [-22, -9.8]Wilcoxon rank-sum
Secondary
Change From Baseline to Day 15&16 in LPS
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
Time frame: From baseline to Day 15&16
Population: All treated patients
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Day 15&16 in LPS | Baseline | 57.3 minutes | 95% Confidence Interval 41.81 |
| Placebo | Change From Baseline to Day 15&16 in LPS | Change from baseline to day 15&16 | -20.0 minutes | 95% Confidence Interval 46.1 |
| Placebo | Change From Baseline to Day 15&16 in LPS | Day 15&16 | 30.0 minutes | 95% Confidence Interval 35.33 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in LPS | Baseline | 57.4 minutes | 95% Confidence Interval 37.03 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in LPS | Change from baseline to day 15&16 | -23.5 minutes | 95% Confidence Interval 35.9 |
| Almorexant 100mg | Change From Baseline to Day 15&16 in LPS | Day 15&16 | 29.3 minutes | 95% Confidence Interval 28.51 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in LPS | Day 15&16 | 24.1 minutes | 95% Confidence Interval 22.48 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in LPS | Baseline | 54.1 minutes | 95% Confidence Interval 32.89 |
| Almorexant 200mg | Change From Baseline to Day 15&16 in LPS | Change from baseline to day 15&16 | -26.5 minutes | 95% Confidence Interval 31.1 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in LPS | Baseline | 56.5 minutes | 95% Confidence Interval 34.6 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in LPS | Change from baseline to day 15&16 | -32.3 minutes | 95% Confidence Interval 34.19 |
| Zolpidem 10mg | Change From Baseline to Day 15&16 in LPS | Day 15&16 | 24.6 minutes | 95% Confidence Interval 25.62 |
Comparison: Change from baseline to day 15\&16 compared with placebop-value: 0.223795% CI: [-11, 2.5]Wilcoxon rank-sum
Comparison: Change from baseline to day 15\&16 compared with placebop-value: 0.060795% CI: [-12.3, 0.3]Wilcoxon rank-sum
Comparison: Change from baseline to day 15\&16 compared with placebop-value: 0.001795% CI: [-17.3, -4]Wilcoxon rank-sum
Secondary
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
sLSO was the self-reported time to fall asleep as reported in the sleep diary
Time frame: From baseline to Week 1&2
Population: All treated patients with available data
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Baseline | 58.8 minutes | 95% Confidence Interval 33.68 |
| Placebo | 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 |
| Placebo | 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 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Baseline | 55.0 minutes | 95% Confidence Interval 50.7 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Change from baseline to week 1&2 | -16.2 minutes | 95% Confidence Interval 34.48 |
| Almorexant 100mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Week 1&2 | 36.5 minutes | 95% Confidence Interval 40.64 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Week 1&2 | 34.5 minutes | 95% Confidence Interval 21.56 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Baseline | 53.3 minutes | 95% Confidence Interval 27.93 |
| Almorexant 200mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Change from baseline to week 1&2 | -16.2 minutes | 95% Confidence Interval 23.22 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Baseline | 50.5 minutes | 95% Confidence Interval 29.34 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Change from baseline to week 1&2 | -17.2 minutes | 95% Confidence Interval 25.67 |
| Zolpidem 10mg | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | Week 1&2 | 33.3 minutes | 95% Confidence Interval 21.5 |
Comparison: Change from baseline to week 1\&2 compared with placebop-value: 0.118795% CI: [-9.1, 0.9]Wilcoxon rank-sum
Comparison: Change from baseline to week 1\&2 compared with placebop-value: 0.001795% CI: [-11.5, -2.7]Wilcoxon rank-sum
Comparison: Change from baseline to week 1\&2 compared with placebop-value: 0.012195% CI: [-10.8, -1.4]Wilcoxon rank-sum