Active substance
Lemborexant
- SFDA 2
- US FDA 1
- Health Canada 2
- US price lines 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| DAYVIGO | 5 mg | Film-coated tablet · Oral use | 28 Blister | SAR 219.60 | NCE · Prescription | EISAI | Valid |
| DAYVIGO | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 219.60 | NCE · Prescription | EISAI | Valid |
Indications — CHI Daman Drug Formulary
INSOMNIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DAYVIGO | 5MG; 10MG | tablet · oral | EISAI INC | Prescription | 20 Dec 2019 |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DAYVIGO 10 MG TABLET | $11.56704 | per EA | 23 Sep 2026 |
| US NADAC | DAYVIGO 5 MG TABLET | $11.57757 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 19 Feb 2025 DAYVIGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.