SLENYTO

• 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.