DAYVIGO (lemborexant)
DAYVIGO is indicated for the treatment of Insomnia.
How DAYVIGO Works
Lemborexant is a dual orexin receptor antagonist (DORA). Its mechanism of action is presumed to be through the antagonism of orexin receptors OX1R and OX2R. By blocking the binding of the wake-promoting neuropeptides orexin A and orexin B to these receptors, the drug suppresses the physiological wake drive.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-12-20
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
DAYVIGO Approval History
What DAYVIGO Treats
1 indicationsDAYVIGO is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
DAYVIGO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DAYVIGO
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06843187 MDD | 24-133 68425v4 | Ph 2 | recruiting | Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) |
| NCT07384429 | 2025401 | Ph 4 | recruiting | Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease |
| NCT07480096 | 24-11-1690 | Ph 2 | completed | Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems |
| NCT05463861 | 59441 | Ph 4 | completed | Lemborexant in Delayed Sleep Phase Syndrome |
| NCT07407400 | LEM-SICU | Ph 4 | not yet recruiting | Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients |
| NCT05344443 results posted | 20-32763 | Ph 4 | completed | Lemborexant Shift Work Treatment Study |
| NCT05594589 results posted | E2006-J082-204 | Ph 2 | completed | A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder |
| NCT06874855 | 23-38738 | Ph 4 | recruiting | Lemborexant in Delayed Sleep Phase Syndrome |
| NCT06262594 L'ÉTOILE | L'ÉTOILE | Ph 3 | recruiting | Lemborexant Treatment of Insomnia Linked to Epilepsy |
| NCT04549168 results posted | E2006-J086-311 | Ph 3 | completed | A Study of Lemborexant in Chinese Participants With Insomnia Disorder |
| NCT04818086 results posted | HM20021136 UG1DA050207 | Ph 1, Ph 2 | completed | Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder |
| NCT02783729 SUNRISE 1 results posted | E2006-G000-304 2015-004347-39 | Ph 3 | completed | Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) |
| NCT06496282 | LEMY-2024 | Ph 3 | recruiting | Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers |
| NCT04890561 | E2006-A001-010 | Ph 1 | completed | A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women |
| NCT04555733 | E2006-J086-014 | Ph 1 | completed | A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants |
| NCT03440424 results posted | E2006-A001-104 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects |
| NCT03443063 results posted | E2006-A001-105 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment |
| NCT02952820 results posted | E2006-G000-303 2015-001463-39 | Ph 3 | completed | Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) |
| NCT03483636 | E2006-A001-009 | Ph 1 | completed | Study of Lemborexant-Alcohol Interaction in Healthy Subjects |
| NCT03451110 | E2006-A001-012 | Ph 1 | completed | Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DAYVIGO FDA Label Details
Indications & Usage
FDA Label (PDF)DAYVIGO is indicated for the treatment of Insomnia.
DAYVIGO Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DAYVIGO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 16 active patents
Trial Analysis
- • 21 total trials
- • Stage: Stable
Competitive Landscape
- • 17 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment