Health Canada Approves Slenyto® - Extended-Release Melatonin Formulation - as a Prescription Drug for Insomnia in Children with Autism Spectrum disorder and Smith Magenis Syndrome

TORONTO, Sept. 10, 2025 /CNW/ -- Neurim Pharmaceuticals is pleased to announce 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.

ABOUT SLENYTO®

Slenyto® is a child appropriate Extended-release oral minitablet (only 3mm diameter), containing melatonin, a naturally occurring hormone that regulates the sleep-wake cycle. Unlike the available melatonin health products, Slenyto® is designed to mimic the physiological release of melatonin, improving both sleep initiation and maintenance throughout the night.

Slenyto® is odorless, tasteless, and easy to swallow, making it suitable for children with sensory sensitivities and/or swallowing difficulties. It is taken once daily, 30 to 60 minutes before bedtime. Minitablets should be swallowed whole and should not be crushed or chewed.

CLINICAL EVIDENCE

Slenyto® has been evaluated in randomized, double-blind, placebo-controlled long term trial involving children with ASD or SMS. Results demonstrated statistically significant improvements in:

• Sleep latency (time to fall asleep)
• Total sleep time
• Sleep continuity (uninterrupted sleep duration)
• Daytime behavior

These benefits were maintained over long-term use, with a favorable safety profile and minimal adverse effects.

INDICATION AND USE

Slenyto® is 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.

A NEW STANDARD IN PEDIATRIC SLEEP CARE

"Neurim is proud to bring Slenyto® to Canada, marking our entry into North America with a first-in-class pediatric treatment for insomnia, addressing an unmet need for ASD and SMS patients across Canada," said Prof. Nava Zisapel, Founder and Chief Scientist at Neurim Pharmaceuticals. "It is the only melatonin-based treatment developed specifically for children with neurodevelopmental conditions, offering a safe and effective solution that improves both sleep and daytime functioning."

"Slenyto® represents a paradigm shift in the management of ASD pediatric insomnia," reports Dr. Shelly Weiss, Professor, Pediatric Neurologist, SickKids, University of Toronto, Pediatric Sleep Expert, and previous President of the Canadian Sleep Society. "Slenyto® paediatric extended-release melatonin is both an effective and safe medication for insomnia in children with autistic spectrum disorders. Adjusting the dosage according to individual response is easy and the formulation is exceptionally well tolerated in this population. The results of Neurim's pivotal study demonstrated clinically significant improvements in sleep duration, maintenance and latency. Related measures of children's daytime mood and behaviors also improve with this treatment, as does the parental quality of life. The treatment will address a significant need in the medical management of children and adolescents with autistic spectrum disorders in Canada."

AVAILABILITY

Slenyto® will be listed in the Prescription Drug List (PDL) and available in Canada in the near future, through pediatric specialists, sleep clinics, and pharmacies nationwide. Neurim Pharmaceuticals is committed to ensuring broad access, including educational support for healthcare providers and caregivers.

ABOUT NEURIM PHARMACEUTICALS

Neurim Pharmaceuticals Ltd. (www.neurim.com) is a neuroscience drug discovery and development company. Its first approved drug, CIRCADIN®, is approved for patients over the age of 55 who are suffering from insomnia and is commercially available in 45 countries around the world.

Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders.

* https://health-products.canada.ca/dpd-bdpp/dispatch-repartition

Media Contact:
Guy Manor, CCO
[email protected]

 

SOURCE Neurim Pharmaceuticals

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