Phase 3 Completed N=1,019 Randomized Double-blind Treatment

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

Insomnia

Source: ClinicalTrials.gov NCT01097629 ↗

Enrolled (actual)

1,019

Serious AEs

0.4%

Results posted

Sep 2014

Primary outcomePrimary: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 — 48.7; 22.4 minutes — p=<0.00001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1	48.7; 22.4	<0.00001 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3	62.8; 37.7	<0.00001 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1	-51.9; -22.5	<0.00001 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3	-54.2; -24.8	<0.00001 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1	-26.9; -14.1	0.00003 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3	-33.7; -20.5	0.00003 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1	-36.7; -24.6	0.00004 sig
PRIMARY Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3	-32.2; -28.6	0.26510
PRIMARY Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase	103; 189; 167	—
PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase	9; 18; 17	—
SECONDARY Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1	40.4; 14.0	<0.00001 sig
SECONDARY Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1	-63.3; -21.3	<0.00001 sig
SECONDARY Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1	-19.7; -6.7	<0.00001 sig
SECONDARY Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1	-34.7; -13.0	<0.00001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01097629). 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. Informational only — not medical advice.