Slenyto: first Rx melatonin product for treating insomnia in children with ASD

Slenyto (melatonin 1 mg and 5 mg extended-release tablets), manufactured by Neurim Pharmaceuticals in Israel, is the first prescription melatonin product to be approved in Canada.1-3 Other melatonin products are currently available without a prescription as Natural Health Products in Canada.Slenyto is indicated for the treatment of insomnia in children and adolescents (age 2 to < 18 years) with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome (SMS), where sleep hygiene measures have been insufficient.2 Sleep disorders affect up to 80% of children with ASD, often exacerbating behavioural and cognitive challenges and placing enormous strain on families.3Melatonin, a naturally occurring hormone produced by the pineal gland, is structurally related to serotonin. It is believed to contribute to sleep-promoting properties by stimulating melatonin receptors that are involved in the control of circadian rhythms and regulation of sleep.2The manufacturer reports that Slenyto has been evaluated in a 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) and daytime behaviour.These benefits were maintained over long-term use, with a favourable safety profile and minimal adverse effects.3The recommended starting dose is 2 mg once daily, taken 30–60 minutes before bedtime. If the child has an inadequate response, the dose should be increased to 5 mg, with a maximum dose of 10 mg. Data are available for up to two years of treatment. Children should be monitored at least every six months to determine whether melatonin is still the most appropriate treatment.2Slenyto tablets can be taken with or after food. The tablets should be swallowed whole, and not broken, crushed or chewed because they will lose their extended-release properties. However, tablets can be put into food (e.g., yogurt, orange juice, ice cream) to facilitate swallowing and improve adherence. Such mixtures should be taken immediately and not stored.2The manufacturer describes Slenyto as an oral “minitablet” as it is only 3 mm in diameter. The tablet is being promoted as odourless, tasteless and easy to swallow, making it suitable for children with sensory sensitivities and/or swallowing difficulties.3The most common adverse effects of Slenyto are somnolence, fatigue, mood swings, headache, upper respiratory tract infection, vomiting, agitation, cough, dyspnea and rash. No serious adverse effects were reported in clinical trials.2No drug interaction studies have been conducted in children. However, melatonin is predominantly metabolized by CYP1A enzymes. Plasma concentrations of melatonin may be decreased by CYP1A2 inducers (e.g., carbamazepine, rifampin); an increase in melatonin dose may be required. CYP1A2 inhibitors (e.g., ciprofloxacin) may increase melatonin plasma concentrations, necessitating an increase in melatonin dose.Fluvoxamine significantly increases melatonin concentrations; avoid this combination. Smoking induces CYP1A2 metabolism; melatonin dose adjustment may be required if a patient starts or stops smoking during treatment with melatonin. Avoid alcohol (including alcohol-containing medications) as it reduces melatonin effectiveness and may alter the prolonged-release characteristics of Slenyto, resulting in immediate release of melatonin.2In conjunction with the approval of Slenyto as a prescription drug, Health Canada announced that it is proposing to expand the listing of “melatonin or its salts” in the Prescription Drug List to encompass any sleep-related use in the general pediatric population. Health Canada will be notifying the public and interested stakeholders about this proposal and allow the opportunity to comment via a Notice of Consultation.1 The marketing date for Slenyto in Canada has yet to be announced, but a company press release suggests that it will be available “in the near future.”3 The Canadian Paediatric Society recently issued a position statement on supporting healthy sleep for children and youth with neurodevelopmental disabilities.4 The statement indicates that most sleep issues in these children can be addressed through measures that improve sleep habits/hygiene along with behavioural strategies that respect cultural diversity and parental priorities. If behavioural strategies fail or are only partially successful, melatonin can be used, with medical supervision. A dosage of 1–3 mg is suggested, administered 30–60 minutes before desired sleep onset, with the dose increased gradually if needed to a maximum of 10 mg. Other medication strategies (used off-label) may be needed in difficult cases, but these should be carefully considered and monitored because most have side effects or the potential to impair sleep quality.4ReferencesGovernment of Canada. Notice of amendment: addition of melatonin to the Prescription Drug List. September 9, 2025. (accessed September 16, 2025).Neurim Pharmaceuticals Ltd. Slenyto (melatonin 1 mg and 5 mg extended-release tablets) product monograph. Tel-Aviv, Israel; September 8, 2025. (accessed September 16, 2025).Neurim Pharmaceuticals. Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith Magenis syndrome. September 10, 2025. (accessed September 16, 2025).Thomas M, Shea S; Canadian Paediatric Society, Mental Health and Developmental Disabilities Committee. Sleep matters: supporting healthy sleep for children and youth with neurodevelopmental disabilities (NDDs). Posted August 19, 2025. (accessed September 16, 2025).

Slenyto: first Rx melatonin product for treating insomnia in children with ASD

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