[A19-04] Melatonin (sleep disorders) - Benefit assessment according to §35a Social Code Book V

Last updated 04.07.2019

Project no.:

Commission awarded on 11.01.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:
Digestion, metabolism and hormones


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


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.

Current document

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

2019-07-04 A G-BA decision was published.

G-BA documents on this decision


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