DAYVIGO

Peak

lemborexant

Eisai
NDAORALTABLET
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Orexin Receptor Antagonists

Pharmacologic Class:

Orexin Receptor Antagonist

Indications (2)

characterized by difficulties with sleep onset and/or sleep maintenanceinsomnia

Clinical Trials (5)

NCT07384429Phase 4Not Yet Recruiting

Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease

Started Feb 2026
44 enrolled
Parkinson's DiseaseInsomniaMotor Disorder
NCT06648681Phase 2Not Yet Recruiting

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Started May 2025
60 enrolled
Delirium - PostoperativeCardiac SurgeryCardiac Surgery Subjects+4 more
NCT06744673N/AActive Not Recruiting

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

Started Jan 2025
861 enrolled
Sleep Initiation and Maintenance DisordersPregnancy
NCT06874855Phase 4Recruiting

Lemborexant in Delayed Sleep Phase Syndrome

Started Mar 2023
15 enrolled
Delayed Sleep Phase Syndrome
NCT05728736Phase 2Withdrawn

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Started Mar 2023
0
Alzheimer Disease

Loss of Exclusivity

LOE Date
Oct 21, 2035
117 months away
Patent Expiry
Oct 21, 2035
Exclusivity Expiry
Apr 20, 2026

Patent Records (4)

Patent #ExpiryTypeUse Code
8268848
Sep 20, 2031
SubstanceProduct
U-2791
10188652
Oct 21, 2035
Product
U-2791
10702529
Oct 21, 2035
Product
—
11026944
Oct 21, 2035
Product
—
Company
E
Eisai
China - Liaoning
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers