Phase 3
N=1,022
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01097616 ↗Enrolled (actual)
1,022
Serious AEs
0.4%
Results posted
Sep 2014
Primary outcome: Primary: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 — 42.6; 23.1 minutes — p=<0.00001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Suvorexant High Dose (HD) (Drug); Suvorexant Low Dose (LD) (Drug); Comparator: Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 |
42.6; 23.1 | <0.00001 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 |
60.3; 40.6 | <0.00001 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 |
-45.0; -18.7 | <0.00001 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 |
-47.9; -25.0 | <0.00001 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 |
-19.1; -11.7 | 0.00298 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 |
-25.7; -17.3 | 0.00019 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 |
-34.5; -23.3 | 0.00002 sig |
| PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 |
-36.0; -26.6 | 0.00037 sig |
| PRIMARY Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase |
126; 198; 191 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase |
6; 18; 23 | — |
| SECONDARY Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1 |
28.2; 36.0; 14.6 | 0.00007 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1 |
39.4; 23.1 | 0.00016 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3 |
51.2; 40.6 | 0.01711 sig |
| SECONDARY Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1 |
-52.1; -58.0; -19.6 | <0.00001 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1 |
-45.0; -18.7 | <0.00001 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3 |
-41.6; -25.0 | 0.00009 sig |
| SECONDARY Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1 |
-15.2; -15.3; -9.6 | 0.01564 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1 |
-17.1; -11.7 | 0.05191 |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3 |
-22.5; -17.3 | 0.03771 sig |
| SECONDARY Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1 |
-29.9; -30.6; -20.3 | 0.00041 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1 |
-33.6; -23.3 | 0.00040 sig |
| SECONDARY Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3 |
-34.7; -26.6 | 0.00606 sig |
Summary
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.
Eligibility Criteria
Inclusion Criteria
- Must be ≥18 yrs old on the day of signing informed consent
- Diagnosed with Primary Insomnia
- Good physical and mental health
- Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
- A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
- Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
- Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
- Regular bedtime is between 9 pm-1 am
- Willing to refrain from napping while in study
- Able to read, understand and complete questionnaires and all diaries
- Willing to limit alcohol, caffeine, and nicotine consumption while in the study
- For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Exclusion Criteria
- Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
- History or diagnosis of another sleep disorder
- Difficulty sleeping due to a medical condition
- History of a neurological disorder
- History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
- Ongoing depression
- History of substance abuse or dependence
- History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
- Taking certain prohibited medications
- Consumption of the equivalent of >15 cigarettes a day
- History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Participant is considered morbidly obese
- Previously randomized in another investigational study of suvorexant
Data sourced from ClinicalTrials.gov (NCT01097616). 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.