Dossier assessment

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

Status
Status: Commission completed
Project no.
A24-24
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 367 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-24_en
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 682 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-24

Dossier assessment

Indication:

Adults with insomnia characterized by symptoms present for at least 3 months and considerable impact on daytime functioning.

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A24-24
Commission
Commission awarded on 01.03.2024 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.

DOI

https://doi.org/10.60584/A24-24_en

Connected Projects

  1. Dossier assessment

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

    Project no.
    A22-123
    Last updated

    Status: Commission completed

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