The Paediatric Investigational Plan (PIP) included a Phase III study demonstrating the product’s short, and long-term efficacy and safety.
Importantly diagnosis (ASD with/ without ADHD or SMS) and co-medication (e.g., stimulants) did not affect Slenyto efficacy outcomes.
The impact of sleep disruption on behaviour can be explained, in part, by the improvement in duration of uninterrupted sleep rather than the improvement in sleep latency. This is of note because the prolonged release formulation of Slenyto, which releases melatonin throughout the night, appears to be effective in improving both sleep onset and sleep maintenance whereas immediate release melatonin formulations are reported as effective in sleep induction but not, or less so, with sleep maintenance.
It is pertinent to ask whether the improvement in parents’ quality of life, subsequent to the improvement in a child’s sleep, might provide a “positive bias” on the parent-completed rating scales of patient behaviour or influence parenting and, therefore, behaviour of children. Yet, the change in caregivers’ quality of life seems strongly related to the improvements in daytime behaviour rather than to the improvements in child’s sleep.
6. Maras, A. et al. Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder. Jnl Child and Adolesc Psychpharmacol. 2018; doi 10.1089:1-12
7. Schroder, C. et al. Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behaviour and Care Giver’s Quality of Life. J Autism and Developmental Disorders. 2019
14. Data on File (RAD Neurim Pharmaceuticals EEC Ltd.)
15. National Sleep Foundation https://thensf.org/how-many-hours-of-sleep-do-you-really-need/. (Accessed October 2021)