Trial · NCT01021813
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
NCT01021813, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3). Trials, record NCT01021813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
- NCT number
- NCT01021813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 781 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Insomnia
- Interventions
- Suvorexant, Dose-matched Placebo to Suvorexant
- First posted
- 2009-11-30
- Last updated
- 2018-09-21
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase | From the first day of study treatment up to 12 months | Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement. |
| Primary | Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep). |
| Primary | Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking). |
| Primary | Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | Falls were adjudicated (to establish whether a fall event was due to cataplexy). |
| Primary | Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI. |
| Primary | Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations. |
| Primary | Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase | From the first day of study treatment up to 12 months | The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse. |
| Secondary | Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ) | Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out]) | Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal). A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights. |
| Secondary | Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1). |
| Secondary | Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase | From the first day of study treatment up to 12 months | All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ) | Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out]) | Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase | Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13) | Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase | Suvorexant | 0.0 | percentage of participants | ||
| Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase | Placebo | 0.0 | percentage of participants | ||
| Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase | Suvorexant | 0.4 | percentage of participants | ||
| Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase | Placebo | 0.0 | percentage of participants | ||
| Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | Suvorexant | any complex sleep-related behaviors | 0.2 | percentage of participants | |
| Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | Placebo | any complex sleep-related behaviors | 0.0 | percentage of participants | |
| Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | Suvorexant | somnambulism | 0.2 | percentage of participants | |
| Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase | Placebo | somnambulism | 0.0 | percentage of participants | |
| Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase | Suvorexant | 2.3 | percentage of participants | ||
| Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase | Placebo | 3.1 | percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Treatment Phase | STARTED | Suvorexant | 522 | |
| DB Treatment Phase | STARTED | Placebo | 259 | |
| DB Treatment Phase | STARTED | Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) | 0 | |
| DB Treatment Phase | STARTED | Suvorexant (DB Treatment)/Placebo (DB Discontinuation) | 0 | |
| DB Treatment Phase | STARTED | Placebo (DB Treatment)/Placebo (DB Discontinuation) | 0 | |
| DB Treatment Phase | Treated | Suvorexant | 521 | |
| DB Treatment Phase | Treated | Placebo | 258 | |
| DB Treatment Phase | Treated | Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) | 0 | |
| DB Treatment Phase | Treated | Suvorexant (DB Treatment)/Placebo (DB Discontinuation) | 0 | |
| DB Treatment Phase | Treated | Placebo (DB Treatment)/Placebo (DB Discontinuation) | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events392
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 | Fatigue | General disorders | Suvorexant | 34 | 521 | 40 |
| other | Fatigue | General disorders | Placebo | 5 | 258 | 5 |
| other | Fatigue | General disorders | Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) | 0 | 156 | 0 |
| other | Fatigue | General disorders | Suvorexant (DB Treatment)/Placebo (DB Discontinuation) | 0 | 166 | 0 |
| other | Fatigue | General disorders | Placebo (DB Treatment)/Placebo (DB Discontinuation) | 1 | 162 | 1 |
| other | Fatigue | General disorders | Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up | 0 | 260 | 0 |
| other | Fatigue | General disorders | Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up | 0 | 261 | 0 |
| other | Fatigue | General disorders | Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up | 0 | 258 | 0 |
| other | Nasopharyngitis | Infections and infestations | Suvorexant | 42 | 521 | 53 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 20 | 258 | 25 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Suvorexant | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) | ||
| Total, all-cause mortality | Suvorexant (DB Treatment)/Placebo (DB Discontinuation) | ||
| Total, all-cause mortality | Placebo (DB Treatment)/Placebo (DB Discontinuation) | ||
| Total, all-cause mortality | Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up | ||
| Total, all-cause mortality | Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up | ||
| Total, all-cause mortality | Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up | ||
| Total, other adverse events | Suvorexant | 184 | 521 |
| Total, other adverse events | Placebo | 63 | 258 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Suvorexant vs Placebo: Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS) |
Source Trial comparisons
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/NCT01021813
GET https://conductscience.org/api/trials/v1/NCT01021813/results?page=2