MedPath

Suvorexant

Generic Name
Suvorexant
Brand Names
Belsomra
Drug Type
Small Molecule
Chemical Formula
C23H23ClN6O2
CAS Number
1030377-33-3
Unique Ingredient Identifier
081L192FO9
Background

Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.

Indication

Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Associated Conditions
Insomnia

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

Phase 3
Completed
Conditions
Primary Insomnia
Interventions
First Posted Date
2010-04-01
Last Posted Date
2018-09-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1023
Registration Number
NCT01097616

Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)

Phase 1
Completed
Conditions
Insomnia
Interventions
First Posted Date
2010-02-01
Last Posted Date
2018-11-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
16
Registration Number
NCT01059851

Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

Phase 1
Completed
Conditions
Hepatic Insufficiency
Insomnia
Interventions
First Posted Date
2010-01-07
Last Posted Date
2018-09-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
16
Registration Number
NCT01043926

A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

Phase 3
Completed
Conditions
Insomnia
Interventions
Drug: Dose-matched Placebo to Suvorexant
First Posted Date
2009-11-30
Last Posted Date
2018-09-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
781
Registration Number
NCT01021813

Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Phase 2
Completed
Conditions
Primary Insomnia
Interventions
Drug: Dose-matched Placebo to Suvorexant
First Posted Date
2008-11-17
Last Posted Date
2018-11-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
254
Registration Number
NCT00792298
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