Last Updated : April 28, 2025
Details
Generic Name:
lemborexant
Project Status:
Active
Therapeutic Area:
Insomnia
Manufacturer:
Eisai Limited
Call for patient/clinician input open:
Brand Name:
Dayvigo
Project Line:
Reimbursement Review
Project Number:
SR0895-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of insomnia in adults diagnosed according to the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) referring to chronic insomnia disorder (CID)
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Indications:
The treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 28-Feb-25 |
|---|---|
| Call for patient/clinician input closed | 29-Apr-25 |
| Submission received | 10-Apr-25 |
| Submission accepted | 28-Apr-25 |
| Review initiated | 29-Apr-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 14-Jul-25 |
| Deadline for sponsors comments | 23-Jul-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 15-Aug-25 |
| Expert committee meeting (initial) | 27-Aug-25 |
| Draft recommendation issued to sponsor | September 09, 2025 To September 11, 2025 |
| Draft recommendation posted for stakeholder feedback | 18-Sep-25 |
| End of feedback period | 03-Oct-25 |
Last Updated : April 28, 2025