Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

daridorexant

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Generic Name:
daridorexant
Project Status:
Active
Therapeutic Area:
Insomnia
Manufacturer:
Idorsia Pharmaceuticals Canada Ltd.
Call for patient/clinician input open:
Brand Name:
Quviviq
Project Line:
Reimbursement Review
Project Number:
SR0862-000
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:
Initial
Fee Schedule:
Schedule A
Indications:
​For the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  1. 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.
Key Milestones2
Call for patient/clinician input open24-Oct-24
Call for patient/clinician input closed20-Dec-24
Submission received05-Dec-24
Submission accepted19-Dec-24
Review initiated20-Dec-24
Draft CADTH review report(s) provided to sponsor for comment24-Mar-25
Deadline for sponsors comments02-Apr-25
CADTH review report(s) and responses to comments provided to sponsor15-May-25
Expert committee meeting (initial)28-May-25
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedback19-Jun-25
End of feedback period04-Jul-25

Files

Patient and Clinician Group input View PDF
Last Updated : January 15, 2025