Reason for request


  • SLENYTO has been granted a marketing authorisation for the treatment of insomnia in children and adolescents aged from 2 to 18 years with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

  • The superiority of melatonin LP over the placebo has been demonstrated on the improvement in total sleep time at 13 weeks with a moderate effect size: +32 minutes for patients with a total sleep time ofapproximately 7 hours 30 min.

Approved for non-hospital pharmacy reimbursement and for hospital treatment.

Clinical Benefit


The actual clinical benefit of SLENYTO is high

Clinical Added Value


SLENYTO provides clinical added value** (CAV IV, minor) in the therapeutic strategy

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