NDAORALTABLET
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
DAYVIGO (lemborexant) by Eisai is orexin receptor antagonists [moa]. Approved for orexin receptor antagonist [epc]. First approved in 2019.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYVIGO (lemborexant) is an oral small-molecule orexin receptor antagonist approved by the FDA on December 20, 2019, for the treatment of insomnia. It works by blocking orexin signaling in the brain, which promotes wakefulness, thereby facilitating sleep initiation and maintenance. As a first-in-class mechanism within the orexin antagonist class, DAYVIGO represents an alternative to traditional benzodiazepines and sedating antihistamines for insomnia management.
$0.0BPart D
9.5 years to LOEMechanism of Action
Orexin Receptor Antagonists
Pharmacologic Class:
Orexin Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Started Mar 2026
44 enrolled
Parkinson's DiseaseInsomniaMotor Disorder
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Started May 2025
60 enrolled
Delirium - PostoperativeCardiac SurgeryCardiac Surgery Subjects+4 more
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
Lemborexant in Delayed Sleep Phase Syndrome
Started Mar 2023
15 enrolled
Delayed Sleep Phase Syndrome
Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
Started Mar 2023
0Alzheimer Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.