SLENYTO® (melatonin extended-release tablets) is now available in Canada as a prescription treatment for insomnia in children and adolescents with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome (SMS).

• SLENYTO® is the first and only prescription melatonin in Canada and the only melatonin authorized for sale by Health Canada for children and adolescents 2 to <18 years of age. ^1,2
  
• Autism Spectrum Disorder affects approximately 1 in 44 (2.25%) Canadian children and youth, 60-86% of children with ASD experience sleep abnormalities.^3,4

MISSISSAUGA, ON, Aug. 11, 2026 /PRNewswire/ -- Kye Pharmaceuticals, Inc. ("Kye") announced today that SLENYTO® (melatonin extended-release tablets) is now available across Canada. SLENYTO® is approved as a prescription medicine in Canada 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.²

SLENYTO® was clinically evaluated and demonstrated both safety and efficacy in pediatric patients with insomnia associated with ASD and/or SMS, conditions that are characterized by disrupted melatonin secretion or an inverted circadian rhythm. SLENYTO® received a Notice of Compliance by Health Canada on September 8, 2025. ^1,7,9

"We are proud to bring the first and only prescription melatonin therapy with a purpose-designed pediatric formulation for this patient population to Canada", said Julian Oliver, Commercial Lead, General Medicines & Business Operations, Kye Pharmaceuticals. "SLENYTO® addresses a significant unmet need for children and adolescents with insomnia and ASD and/or SMS, as well as their families and the physicians who care for them."

SLENYTO® is an extended-release melatonin formulation designed to mimic the natural nighttime secretion of melatonin. It is available as a pediatric-appropriate odourless, tasteless 3mm mini-tablet. The efficacy, safety, and tolerability of SLENYTO® have been established through a 13-week placebo controlled clinical trial and a 91-week open label period to assess effects of long-term use in children and adolescents.^2,5

"In my practice I see a high variability with how families select, dose or benefit from a multitude of over-the-counter melatonin health supplements to support sleep." Said Dr. Shelly Weiss, Professor, Pediatric Neurologist, SickKids, University of Toronto, Pediatric Sleep Expert, and previous President of the Canadian Sleep Society. "SLENYTO® gives clinicians the first extended-release option specifically developed, studied and approved for children with autism spectrum disorder in Canada." 

SLENYTO® is now available by prescription through pharmacies across Canada.

About Autism Spectrum Disorder and Insomnia

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by differences in social communication and interaction, alongside restricted or repetitive patterns of behavior and interests, with a diverse presentation between individuals⁶. Sleep disturbances are common in children with ASD and stem from multifactorial causes including, genetic, environmental, immunological, and neurological factors. Maintaining a healthy sleep schedule helps children with autism and their caregivers thrive, as improved sleep is linked to improved daytime behavior and better quality of life for both the child and the caregiver.^7,8

About Smith-Magenis Syndrome

Smith-Magenis Syndrome (SMS) is a rare genetic disorder caused by a deletion or mutation involving the RAI1 gene on chromosome 17, characterized by distinctive physical features, developmental delay, and a recognizable cluster of behavioural traits, including self-injurious behaviors, aggression, and repetitive movements. Sleep disturbance is one of the most prominent features of this phenotype, largely driven by an inverted circadian rhythm. Rather than rising at night as it normally does, melatonin peaks during the day, disrupting the sleep-wake cycle and contributing to frequent nighttime waking, early morning awakenings, and excessive daytime sleepiness.^9,10

About SLENYTO®

SLENYTO® is the only prescription melatonin in Canada. It is a patented extended-release melatonin available in a pediatric-appropriate 3mm mini-tablet. More information about SLENYTO®, can be found at: www.kyepharma.com.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals is focused on the discovery and development of groundbreaking new medicines for disorders related to the central nervous system (CNS). With a proven track record of drug development and commercialization, Neurim's first products, Circadin® and Slenyto®, are already in use in more than 40 countries across 5 continents. Constantly expanding into additional therapeutic areas, the R&D pipeline comprises new products that address sleep and neurodevelopmental disorders. Through pioneering scientific research and CNS focused drug development as well as collaboration with public and private healthcare organizations, Neurim Pharmaceuticals is realizing its vision, addressing key unmet needs in CNS disease management, improving the quality of life of patients and their families. To learn more about Neurim Pharmaceuticals, visit the company website at https://neurim.com. SLENYTO® is a registered trademark of Neurim Pharmaceuticals.

About Kye Pharmaceuticals Inc.

Kye is a growth-stage Canadian specialty pharmaceutical company, headquartered in Toronto, committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that are not otherwise available to patients across Canada. With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including neurology, psychiatry, pediatrics, rare diseases, hematology, cardiology and neuromuscular disorders. Kye is focused on licensing and launching medicines that matter, and delivering better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information, please visit www.kyepharma.com.

1. Data on File. Kye Pharmaceuticals; 2026.
2. Slenyto® Product Monograph. Neurim Pharmaceuticals Ltd.
3. Public Health Agency of Canada. Understanding autism data in the Canadian Chronic Disease Surveillance System. PHAC; 2025. Available from: https://health-infobase.canada.ca/autism/
4. Reynolds AM, Malow BA. Sleep and autism spectrum disorders. Pediatr Clin North Am. 2011;58(3):685-698.
5. Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and safety of pediatric prolonged-release melatonin for insomnia in children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948-957.e4. doi:10.1016/j.jaac.2017.09.414
6. Tafolla M, Singer H, Lord C. Autism spectrum disorder across the lifespan. Annu Rev Clin Psychol. 2025;21:193-220. doi:10.1146/annurev-clinpsy-081423-031110
7. Souders M, et al. An update on the cause and treatment of sleep disturbance in children and adolescents with ASD. PMC; 2021.
8. Golden S, et al. Treatment for sleep problems in children with autism and caregiver spillover effects. PMC; 2015.
9. Poisson A, et al. Smith-Magenis syndrome-clinical review, biological background and related disorders. PMC; 2022.
10. Boudreau A, et al. Behavioral disturbance and treatment strategies in Smith-Magenis syndrome. PMC; 2015.

SOURCE Kye Pharmaceuticals Inc.