Dossier assessment

Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-04
Last updated

Report documents

  1. Extract of dossier assessment

    Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 167 kB, EN, PDF
  2. Dossier assessment

    Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 228 kB, DE, PDF

Dossier assessment

Indication:

Insomnia in children and adolescents with Autism Spectrum Disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient

Result of dossier assessment:

Added benefit not proven due to lack of informative study data

Additional information

Federal Joint Committee (G-BA)

17 October 2024: The G-BA’s decision of 4 July 2019 was cancelled.
G-BA documents on this decision

Project details

Project no.
A19-04
Commission
Commission awarded on 11.01.2019 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

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