Trial · NCT01097616
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
NCT01097616, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-09-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028). Trials, record NCT01097616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01097616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
- NCT number
- NCT01097616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,023 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Primary Insomnia
- Interventions
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD), Comparator: Placebo
- First posted
- 2010-04-01
- Last updated
- 2018-09-21
- Results first posted
- 2014-09-01
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 | Baseline and Month 1 | sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography \[PSG\] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Baseline and Month 3 | sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 | Baseline and Month 1 | WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 | Baseline and Month 3 | WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 | Baseline and Month 1 | sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 | Baseline and Month 3 | sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 | Baseline and Month 1 | LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center. |
| Primary | Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 | Baseline and Month 3 | LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center. |
| Primary | Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase | Up to 3 months | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary. |
| Primary | Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase | Up to 3 months | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 | Baseline and Month 3 | Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1 | Baseline and Week 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1 | Baseline and Month 1 | Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis. | minutes | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 | Suvorexant HD | 42.6 | 95% Confidence Interval 37.3 to 48.0 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 | Placebo | 23.1 | 95% Confidence Interval 17.7 to 28.4 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Suvorexant HD | 60.3 | 95% Confidence Interval 54.8 to 65.8 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 | Placebo | 40.6 | 95% Confidence Interval 35.0 to 46.1 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 | Suvorexant HD | -45.0 | 95% Confidence Interval -50.1 to -39.9 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 | Placebo | -18.7 | 95% Confidence Interval -23.7 to -13.6 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 | Suvorexant HD | -47.9 | 95% Confidence Interval -53.2 to -42.6 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 | Placebo | -25.0 | 95% Confidence Interval -30.3 to -19.8 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 | Suvorexant HD | -19.1 | 95% Confidence Interval -22.6 to -15.7 | minutes | |
| Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 | Placebo | -11.7 | 95% Confidence Interval -15.2 to -8.2 | minutes |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow80
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase) | 254 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Suvorexant High Dose (HD) (TRT/EXT Phase) | 383 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Placebo (TRT/EXT Phase) | 385 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT) | 0 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Placebo (RO, After Suvorexant LD in TRT/EXT) | 0 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Suvorexant HD (RO, After Suvorexant HD in TRT/EXT) | 0 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Placebo (RO, After Suvorexant HD in TRT/EXT) | 0 | |
| Double-Blind (DB) Treatment (TRT) Phase | STARTED | Placebo (RO, After Placebo in TRT/EXT) | 0 | |
| Double-Blind (DB) Treatment (TRT) Phase | Treated | Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase) | 254 | |
| Double-Blind (DB) Treatment (TRT) Phase | Treated | Suvorexant High Dose (HD) (TRT/EXT Phase) | 383 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 participant flowAdverse events437
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nasopharnygitis | Infections and infestations | Suvorexant LD (TRT Phase) | 18 | 254 | 18 |
| other | nasopharnygitis | Infections and infestations | Suvorexant HD (TRT Phase) | 32 | 383 | 33 |
| other | nasopharnygitis | Infections and infestations | Placebo (TRT Phase) | 34 | 384 | 35 |
| other | nasopharnygitis | Infections and infestations | Suvorexant LD (EXT Phase) | 4 | 100 | 4 |
| other | nasopharnygitis | Infections and infestations | Suvorexant HD (EXT Phase) | 9 | 172 | 10 |
| other | nasopharnygitis | Infections and infestations | Placebo (EXT Phase) | 1 | 151 | 1 |
| other | nasopharnygitis | Infections and infestations | Suvorexant LD (RO, After Suvorexant LD in TRT/EXT) | 1 | 102 | 1 |
| other | nasopharnygitis | Infections and infestations | Placebo (RO, After Suvorexant LD in TRT/EXT) | 0 | 111 | 0 |
| other | nasopharnygitis | Infections and infestations | Suvorexant HD (RO, After Suvorexant HD in TRT/EXT) | 0 | 160 | 0 |
| other | nasopharnygitis | Infections and infestations | Placebo (RO, After Suvorexant HD in TRT/EXT) | 1 | 162 | 1 |
1 to 10 of 437Source ClinicalTrials.gov
See all 437 adverse eventsAdverse event totals57
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Suvorexant LD (TRT Phase) | ||
| Total, all-cause mortality | Suvorexant HD (TRT Phase) | ||
| Total, all-cause mortality | Placebo (TRT Phase) | ||
| Total, all-cause mortality | Suvorexant LD (EXT Phase) | ||
| Total, all-cause mortality | Suvorexant HD (EXT Phase) | ||
| Total, all-cause mortality | Placebo (EXT Phase) | ||
| Total, all-cause mortality | Suvorexant LD (RO, After Suvorexant LD in TRT/EXT) | ||
| Total, all-cause mortality | Placebo (RO, After Suvorexant LD in TRT/EXT) | ||
| Total, all-cause mortality | Suvorexant HD (RO, After Suvorexant HD in TRT/EXT) | ||
| Total, all-cause mortality | Placebo (RO, After Suvorexant HD in TRT/EXT) |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01097616
GET https://conductscience.org/api/trials/v1/NCT01097616/registered?page=2