Dossier assessment

Daridorexant (chronic insomnia) - Benefit assessment according to § 35a SGB V

Status
Status: Commission completed
Project no.
A22-123
Last updated

Report documents

  1. Extract of dossier assessment

    Daridorexant (chronic insomnia) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 363 kB, EN, not accessible
  2. Dossierbewertung

    Daridorexant (chronic insomnia) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 518 kB, DE, not accessible

Dossier assessment

Indication:

Adults with insomnia, characterized by symptoms present for at least 3 months, who have not responded to cognitive behavioural therapy or for whom this type of therapy is not suitable or not feasible

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2023-05-12 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-123
Commission
Commission awarded on 16.11.2022 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Head and nerves
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

Connected Projects

  1. Addendum

    Daridorexant (insomnia) – Addendum to Commission A22-123

    Project no.
    A23-22
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Daridorexant (insomnia) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-24
    Last updated

    Status: Commission completed

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