Neurim Pharmaceuticals announced that Health Canada has granted marketing authorization for Slenyto®, an Extended-release melatonin minitablet indicated for the treatment of insomnia in children and adolescents aged 2 to <18 years with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome (SMS), where sleep hygiene measures have been insufficient.
Slenyto® is the first and only pharmacotherapy specifically developed, clinically tested and approved for insomnia in this population, addressing a critical unmet medical need. Sleep disorders affect up to 80% of children with ASD, often exacerbating behavioral and cognitive challenges and placing immense strain on families. This approval marks a significant advancement in pediatric sleep medicine for Canadian patients, offering a clinically proven, well-tolerated, and child-friendly remedy for children with ASD affected by chronic sleep disturbances and their families.
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