Phase 3
N=781
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01021813 ↗Enrolled (actual)
781
Serious AEs
2.6%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase — 0.0; 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Suvorexant (Drug); Dose-matched Placebo to Suvorexant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase |
0.4; 0.0 | — |
| PRIMARY Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase |
0.2; 0.0; 0.2; 0.0 | 0.482 |
| PRIMARY Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase |
2.3; 3.1 | 0.508 |
| PRIMARY Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase |
0.8; 0.0 | 0.159 |
| PRIMARY Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase |
0.8; 0.0; 0.6; 0.0; 0.2; 0.0 | 0.159 |
| PRIMARY Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase |
3.5; 3.9; 2.3; 3.9; 0.2; 0.0 | 0.767 |
| SECONDARY Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ) |
0.8; 1.6; 1.5; 0.8; 3.2; 2.4 | 0.567 |
| SECONDARY Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase |
17.5; 33.8; 28.8; 19.6; 35.6; 26.9 | 0.365 |
| SECONDARY Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase |
16.8; 26.8; 22.3; 18.8; 30.1; 24.8 | 0.386 |
| SECONDARY Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase |
41.1; 14.1; 32.4; 14.7; 39.6; 16.4 | <0.0001 sig |
| SECONDARY Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase |
-17.7; -6.8; -15.7; -7.5; -18.7; -10.0 | 0.0002 sig |
Summary
This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.
The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary insomnia
- Participant is able to read, understand, and complete questionnaires and diaries
- If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
- If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)
Exclusion Criteria
- If female, participant is pregnant
- Participant expects to donate eggs or sperm during the study
- Recent and/or active history of a confounding neurological disorder
- History of clinically unstable cardiovascular disorder within the last 6 months
- Lifetime history of bipolar disorder
- Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study
- History of substance abuse/dependence
- History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item ([QIDS-SR16] suicide item #12)
- Participant has travelled across >3 time zones or >3 hour time difference in the last 2 weeks
- History of permanent night shift work or rotating day/night shift work in the past 2 weeks
- Body Mass Index (BMI) >40 kg/m^2
Data sourced from ClinicalTrials.gov (NCT01021813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.