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Suvorexant

Phase 1

Healthy Non-dependent, Recreational Sedative Users | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

Suvorexant · 1 trial · 2 indications

Phase 1 1
NCT05106153A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and ZolpidemHealthy Non-dependent, Recreational Sedative Users
COMPLETED127 Analytics
PHASE1COMPLETED
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
Healthy Non-dependent, Recreational Sedative UsersUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Up to 24 hour post-dose (up to Day 2)

Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).

Secondary Endpoints

Overall Drug Liking VAS (Emax)
12 hour and 24 hour post-dose
Take Drug Again VAS (Emax)
12 hour and 24 hour post-dose
Subjective Drug Value (Emax)
12 hour and 24 hour post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Qualification Phase: Treatment Sequence YXZEXPERIMENTALParticipants will receive a single oral dose of suvorexant (Treatment Y) in qualification period 1, followed by single oral dose of placebo (Treatment X) in qualification period 2 and then single oral dose of zolpidem (Treatment Z) in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Qualification Phase: Treatment Sequence ZYXEXPERIMENTALParticipants will receive Treatment Z in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Qualification Phase: Treatment Sequence XZYEXPERIMENTALParticipants will receive Treatment X in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Qualification Phase: Treatment Sequence YZXEXPERIMENTALParticipants will receive Treatment Y in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Qualification Phase: Treatment Sequence ZXYEXPERIMENTALParticipants will receive Treatment Z in qualification period 1, followed by Treatment X in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during qualification phase. Each treatment will be separated by washout of at least 3 days.
Qualification Phase: Treatment Sequence XYZEXPERIMENTALParticipants will receive Treatment X in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment Z in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Treatment Phase: Treatment Sequence ABFCEDEXPERIMENTALParticipants will receive a single oral dose of placebo (Treatment A) in treatment period 1, followed by single oral dose of suvorexant (Treatment B) in treatment period 2, single oral Dose 3 of seltorexant (Treatment F) in treatment period 3, single oral dose of zolpidem (Treatment C) in treatment period 4, single oral Dose 2 of seltorexant (Treatment E) in treatment period 5 and then a single oral Dose 1 of seltorexant (Treatment D) in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
Treatment Phase: Treatment Sequence BCADFEEXPERIMENTALParticipants will receive Treatment B in treatment period 1, followed by Treatment C in treatment period 2, Treatment A in treatment period 3, Treatment D in treatment period 4, Treatment F in treatment period 5 and then Treatment E in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
Treatment Phase: Treatment Sequence CDBEAFEXPERIMENTALParticipants will receive Treatment C in treatment period 1, followed by Treatment D in treatment period 2, Treatment B in treatment period 3, Treatment E in treatment period 4, Treatment A in treatment period 5 and then Treatment F in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
Treatment Phase: Treatment Sequence DECFBAEXPERIMENTALParticipants will receive Treatment D in treatment period 1, followed by Treatment E in treatment period 2, Treatment C in treatment period 3, Treatment F in treatment period 4, Treatment B in treatment period 5 and then Treatment A in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
Treatment Phase: Treatment Sequence: EFDACBEXPERIMENTALParticipants will receive Treatment E in treatment period 1, followed by Treatment F in treatment period 2, Treatment D in treatment period 3, Treatment A in treatment period 4, Treatment C in treatment period 5 and then Treatment B in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
Treatment Phase: Treatment Sequence FAEBDCEXPERIMENTALParticipants will receive Treatment F in treatment period 1, followed by Treatment A in treatment period 2, Treatment E in treatment period 3, Treatment B in treatment period 4, Treatment D in treatment period 5 and Treatment C in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Interventions

NameTypeDescription
SuvorexantDRUGSuvorexant will be administered orally as per assigned treatment sequence.
ZolpidemDRUGZolpidem will be administered orally as per assigned treatment sequence.
SeltorexantDRUGSeltorexant will be administered orally as per assigned treatment sequence.
PlaceboDRUGPlacebo will be administered orally as per assigned treatment sequence.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Be a current, recreational, not physically dependent, drug user * Participant must be medically stable * All female participants must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of...

Countries:United States
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Frequently asked questions about Suvorexant

What is Suvorexant used for?

Suvorexant is an investigational small molecule being studied in healthy, non-dependent, recreational sedative users. It is being evaluated in the context of abuse potential research, specifically in a clinical trial that compares it to seltorexant and zolpidem. The drug is not approved and remains in clinical development.

Who makes Suvorexant?

Suvorexant is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this investigational small molecule in the United States.

What phase is Suvorexant in?

Suvorexant is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its abuse potential in healthy, non-dependent, recreational sedative users.

What clinical trials is Suvorexant in?

Suvorexant has one completed Phase 1 clinical trial registered as NCT05106153. This study, titled 'A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem,' enrolled 127 participants in the United States. The trial was randomized, double-blind, and controlled.

Is Suvorexant the same as seltorexant?

No, Suvorexant is not the same as seltorexant. They are distinct drugs that were compared in a clinical trial. The study NCT05106153 evaluated the abuse potential of seltorexant relative to suvorexant and zolpidem, indicating these are separate investigational compounds.