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Licensed Melatonin for ASD Sleep — MRCPsych Paper B MCQ

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HardChild & Adolescent PsychiatryLicensed Melatonin for ASD SleepMRCPsych Paper B

A 4-year-old girl with autism spectrum disorder and intellectual disability has persistent sleep-onset delay and repeated nocturnal awakenings despite an appropriately implemented behavioural sleep plan. If melatonin is prescribed, which formulation has a current UK marketing authorisation that covers her age and clinical indication?

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Reveal the answer and explanation

Correct answer: D — Slenyto prolonged-release melatonin tablets

Slenyto is prolonged-release melatonin licensed for insomnia in children and adolescents aged 2–18 years with ASD when sleep-hygiene measures have been insufficient. It therefore covers this 4-year-old and her mixed sleep-onset and sleep-maintenance difficulties. Syncrodin is now licensed for prolonged sleep onset in ASD, but only from age 6 years, making it unsuitable as the licensed answer here. Circadin and equivalent adult prolonged-release 2 mg products are licensed for primary insomnia in people aged 55 years or older. The listed oral solution has paediatric licences including ADHD-associated insomnia, but not ASD-associated insomnia. An extemporaneous preparation does not itself have a marketing authorisation.

Reference: Electronic Medicines Compendium, Slenyto 1 mg prolonged-release tablets, SmPC sections 4.1 and 5.1, updated 2025. https://www.medicines.org.uk/emc/product/10023/smpc