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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_583 | Other Identifier | Merck Registration Number |
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A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant 10 mg → Placebo | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Placebo → Suvorexant 10 mg | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Suvorexant 20 mg → Placebo | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Placebo → Suvorexant 20 mg | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | oral tablet taken before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| LS Mean Sleep Efficiency (SE) During Periods 1 and 2 | SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100 | Night 1 and end of Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 | WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. | Night 1 and end of Week 4 |
| LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23197752 | Result | Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant 10 mg → Placebo | After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
| FG001 | Placebo → Suvorexant 10 mg | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2. |
| FG002 | Suvorexant 20 mg → Placebo | After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
| FG003 | Placebo → Suvorexant 20 mg | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2. |
| FG004 | Suvorexant 40 mg → Placebo | After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
| FG005 | Placebo → Suvorexant 40 mg | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2. |
| FG006 | Suvorexant 80 mg → Placebo | After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
| FG007 | Placebo → Suvorexant 80 mg | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated Participants | All randomized participants who received at least one dose of study treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LS Mean Sleep Efficiency (SE) During Periods 1 and 2 | SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100 | Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint. | Posted | Least Squares Mean | Standard Error | percent of time in bed | Night 1 and end of Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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|
| Suvorexant 40 mg → Placebo | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Placebo → Suvorexant 40 mg | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Suvorexant 80 mg → Placebo | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. |
|
| Placebo → Suvorexant 80 mg | Experimental | After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2. |
|
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| Dose-matched Placebo to Suvorexant | Drug | Dose-matched placebo to suvorexant taken before bedtime (oral tablet) |
|
LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. |
| Night 1 and end of Week 4 |
| Lack of Efficacy |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| COMPLETED |
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| NOT COMPLETED |
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|
| COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Suvorexant 10 mg | Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period. |
| OG002 | Suvorexant 20 mg | Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period. |
| OG003 | Suvorexant 40 mg | Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period. |
| OG004 | Suvorexant 80 mg | Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period. |
|
|
|
| Secondary | LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 | WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. | Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint. | Posted | Least Squares Mean | Standard Error | minutes | Night 1 and end of Week 4 |
|
|
|
|
| Secondary | LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2 | LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. | Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint. | Posted | Least Squares Mean | Standard Error | minutes | Night 1 and end of Week 4 |
|
|
|
|
| Post-Hoc | LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect) | LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed. | Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint. | Posted | Least Squares Mean | Standard Error | minutes | Night 1 (Period 1 only) and end of Week 4 (Period 1 only) |
|
|
|
|
| 0 |
| 249 |
| 9 |
| 249 |
| EG001 | Suvorexant 10 mg | Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period. | 0 | 62 | 1 | 62 |
| EG002 | Suvorexant 20 mg | Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period. | 0 | 61 | 4 | 61 |
| EG003 | Suvorexant 40 mg | Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period. | 0 | 59 | 11 | 59 |
| EG004 | Suvorexant 80 mg | Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period. | 0 | 61 | 11 | 61 |
| Headache | Nervous system disorders | MedDRA 12.1 |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D001523 |
| Mental Disorders |
| Week 4 (n=232, 59, 57, 57, 55) |
|
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Week 4 | -28.9 | 2-Sided | 95 | -42.1 | -15.7 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Night 1 | -33.9 | 2-Sided | 95 | -46.4 | -21.5 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Week 4 | -33.2 | 2-Sided | 95 | -46.3 | -20.2 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Night 1 | -24.7 | 2-Sided | 95 | -37.1 | -12.3 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Week 4 | -28.1 | 2-Sided | 95 | -41.0 | -15.1 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Night 1 | -21.2 | 2-Sided | 95 | -33.5 | -8.8 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.001 | LS Mean Difference: Week 4 | -21.4 | 2-Sided | 95 | -34.2 | -8.7 | Superiority or Other |
| Week 4 (n=232, 59, 57, 57, 55) |
|
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.068 | LS Mean Difference: Week 4 | -9.5 | 2-Sided | 95 | -19.7 | 0.7 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Night 1 | -23.1 | 2-Sided | 95 | -35.3 | -10.9 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.459 | LS Mean Difference: Week 4 | -3.8 | 2-Sided | 95 | -13.8 | 6.3 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.130 | LS Mean Difference: Night 1 | -9.4 | 2-Sided | 95 | -21.5 | 2.8 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Week 4 | -22.3 | 2-Sided | 95 | -32.3 | -12.3 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.577 | LS Mean Difference: Night 1 | -3.4 | 2-Sided | 95 | -15.6 | 8.7 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.644 | LS Mean Difference: Week 4 | -2.3 | 2-Sided | 95 | -12.2 | 7.5 | Superiority or Other |
| Week 4 (n=116, 29, 31, 30, 28) |
|
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.024 | LS Mean Difference: Week 4 | -19.6 | 2-Sided | 95 | -36.6 | -2.6 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | <0.001 | LS Mean Difference: Night 1 | -31.0 | 2-Sided | 95 | -46.9 | -15.2 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.063 | LS Mean Difference: Week 4 | -15.7 | 2-Sided | 95 | -32.3 | 0.8 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.030 | LS Mean Difference: Night 1 | -17.4 | 2-Sided | 95 | -33.1 | -1.7 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.003 | LS Mean Difference: Week 4 | -24.6 | 2-Sided | 95 | -41.0 | -8.3 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.020 | LS Mean Difference: Night 1 | -19.1 | 2-Sided | 95 | -35.1 | -3.0 | Superiority or Other |
| A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses. | Mixed Models Analysis | 0.019 | LS Mean Difference: Week 4 | -20.2 | 2-Sided | 95 | -37.0 | -3.4 | Superiority or Other |