A Restful Revolution: First Prescription Melatonin for Children with Autism Arrives in Canada

MISSISSAUGA, ON – January 13, 2026 – For thousands of Canadian families navigating the complexities of Autism Spectrum Disorder (ASD) and the rare Smith-Magenis Syndrome (SMS), sleepless nights are a profound and persistent challenge. Today, a significant step forward was announced as Kye Pharmaceuticals, a Canadian specialty pharmaceutical company, secured the exclusive rights to license and distribute SLENYTO®, the first and only prescription medication specifically designed to treat insomnia in children and adolescents with these neurodevelopmental disorders.

The agreement with international neuroscience firm Neurim Pharmaceuticals positions Kye to introduce the Health Canada-approved therapy to a population grappling with a severe unmet medical need. SLENYTO®, an extended-release formulation of melatonin, represents a paradigm shift from the patchwork of off-label medications and unregulated supplements that have long been the only options for these children.

"This agreement is fully aligned with Kye's mission to bring differentiated, clinically meaningful therapies to patients in Canada with high unmet medical needs," said John McKendry, President of Kye Pharmaceuticals, in a statement. "Sleep disorders and insomnia in particular place a substantial burden on children with autism and their families, and SLENYTO® offers a well-studied, prescription-grade, child appropriate extended-release option designed specifically for this population."

The Pervasive Burden of Insomnia

The scale of the problem is immense. According to the Public Health Agency of Canada, ASD affects approximately 1 in 50 children and youth, which translates to an estimated 150,000 individuals in Canada. Within this group, as well as the smaller population of children with the rare genetic disorder SMS, between 50% and 80% suffer from chronic insomnia—a rate far exceeding that of their neurotypically developing peers.

This is not merely a matter of being tired. For children with neurodevelopmental disorders, chronic sleep deprivation can have a cascading negative effect on their lives. Research has demonstrated a clear link between poor sleep and impairments in executive function, which governs intellectual development, emotional regulation, and behaviour. The resulting daytime challenges, including inattention, hyperactivity, and aggression, can hinder learning, social integration, and overall quality of life.

The strain extends to the entire family unit. Caregivers often face their own sleep deprivation and heightened stress levels, creating a cycle of exhaustion and anxiety. The search for a solution has historically led parents and physicians down a difficult path, often resorting to strategies with significant drawbacks.

A New Era Beyond Off-Label and OTC

Before SLENYTO®'s approval by Health Canada on September 8, 2025, the therapeutic landscape for pediatric insomnia in ASD was sparse. First-line treatments typically involve behavioural interventions and strict sleep hygiene routines, which can be challenging to implement and are not always sufficient. Many families turn to over-the-counter (OTC) melatonin supplements, but these products are not regulated as pharmaceuticals, leading to inconsistencies in purity, dosage, and formulation. Critically, standard OTC melatonin is immediate-release, which may help a child fall asleep but often fails to keep them asleep through the night.

In more persistent cases, physicians have resorted to prescribing medications off-label, including antidepressants like trazodone, antipsychotics, or alpha-adrenergic drugs such as clonidine. While these can induce sleep, they were not developed for this purpose in children, carry their own profiles of potential side effects, and lack the robust clinical data for pediatric insomnia that SLENYTO® now provides.

SLENYTO® was engineered to fill this void. Developed using Neurim Pharmaceuticals' proprietary technology, the medication is formulated in small (1 mg and 5 mg) extended-release tablets. This design mimics the body’s natural, overnight secretion of melatonin, helping to regulate the sleep-wake cycle. The goal is not just to initiate sleep but to maintain it, leading to longer, more restorative rest. Clinical trials have validated this approach, showing significant improvements in total sleep time and sleep continuity, with corresponding benefits in daytime mood and behaviour, as well as a marked improvement in parental quality of life.

A Strategic Partnership for a Specialized Need

The partnership between Neurim and Kye is a strategic convergence of innovation and commercialization expertise. Neurim, the developer behind SLENYTO® and the adult insomnia drug CIRCADIN®, brings deep scientific knowledge in circadian rhythms.

"It is the only melatonin-based treatment developed specifically for children with neurodevelopmental disorders, offering a safe and effective solution that improves both sleep and daytime functioning," stated Prof. Nava Zisapel, Founder and Chief Scientific Officer at Neurim Pharmaceuticals. "We believe collaborating with Kye and their strong focus on specialty care, and expertise in the pediatric neurodevelopmental field are a great match for Neurim."

For its part, Kye Pharmaceuticals has built a reputation in Canada for successfully launching specialized therapies. Its portfolio includes treatments for ADHD, such as Quillivant XR, and rare conditions like Lambert-Eaton myasthenic syndrome. This experience in navigating the regulatory, reimbursement, and distribution complexities of the Canadian pediatric and neurology markets makes it an ideal partner to ensure SLENYTO® reaches the patients who need it.

Under the agreement, Kye will manage all regulatory, commercial, and distribution activities for the drug in Canada. This move solidifies Kye’s position as a key player in the Canadian specialty pharmaceutical sector, focused on addressing niche markets where a high unmet need exists. The introduction of SLENYTO® provides a new, evidence-based tool for healthcare practitioners and a new source of hope for families who have long endured the profound challenges of chronic sleeplessness.