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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR SUVOREXANT

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All Clinical Trials for Suvorexant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00792298 ↗ Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) Completed Merck Sharp & Dohme Corp. Phase 2 2008-11-01 A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
NCT01021813 ↗ A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) Completed Merck Sharp & Dohme Corp. Phase 3 2009-12-01 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.
NCT01043926 ↗ Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017) Completed Merck Sharp & Dohme Corp. Phase 1 2010-02-01 This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
NCT01059851 ↗ Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 1 2010-05-01 This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants.
NCT01097616 ↗ Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028) Completed Merck Sharp & Dohme Corp. Phase 3 2010-05-01 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.
NCT01097629 ↗ Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) Completed Merck Sharp & Dohme Corp. Phase 3 2010-05-01 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.
NCT01293006 ↗ Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) Completed Merck Sharp & Dohme Corp. Phase 1 2011-03-01 This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Suvorexant

Condition Name

Condition Name for Suvorexant
Intervention Trials
Insomnia 19
Sleep Disturbance 3
Primary Insomnia 3
Posttraumatic Stress Disorder 2
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Condition MeSH

Condition MeSH for Suvorexant
Intervention Trials
Sleep Initiation and Maintenance Disorders 22
Sleep Wake Disorders 8
Parasomnias 7
Disease 5
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Clinical Trial Locations for Suvorexant

Trials by Country

Trials by Country for Suvorexant
Location Trials
United States 39
Japan 5
Canada 2
Peru 1
Spain 1
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Trials by US State

Trials by US State for Suvorexant
Location Trials
California 6
Maryland 4
Michigan 3
Texas 3
Washington 2
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Clinical Trial Progress for Suvorexant

Clinical Trial Phase

Clinical Trial Phase for Suvorexant
Clinical Trial Phase Trials
Phase 4 18
Phase 3 6
Phase 2/Phase 3 1
[disabled in preview] 19
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Clinical Trial Status

Clinical Trial Status for Suvorexant
Clinical Trial Phase Trials
Not yet recruiting 23
Recruiting 13
Completed 8
[disabled in preview] 2
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Clinical Trial Sponsors for Suvorexant

Sponsor Name

Sponsor Name for Suvorexant
Sponsor Trials
Merck Sharp & Dohme Corp. 17
Massachusetts General Hospital 3
Stanford University 2
[disabled in preview] 8
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Sponsor Type

Sponsor Type for Suvorexant
Sponsor Trials
Other 42
Industry 22
U.S. Fed 5
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