Prolonged-Release Melatonin for Pediatric Insomnia in Autism and/or ADHD: A Four-Case Series

Valeria Mammarella, Maria Breda, Raffaele Ferri and Oliviero Bruni*

Department of Psychology, Sapienza University of Rome, ItalySleep Research Centre, Oasi Research Institute-IRCCS, Troina, Italy Department of Human Neuroscience, Sapienza University of Rome, Italy

^*Correspondance to: Oliviero Bruni 

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Abstract:

Background: Insomnia is highly prevalent in children with autism spectrum disorder (ASD) and/ or attention-deficit/hyperactivity disorder (ADHD), and often persists despite optimized sleep hygiene, behavioral interventions, and, in some cases, immediate-release melatonin. This study describes real-world use of pediatric prolonged-release melatonin (PedPRM) in four such complex cases when first-line strategies are insufficient. Case Presentation: Consecutive clinic cases underwent baseline clinical assessment, parent sleep diaries, the Sleep Disturbance Scale for Children (SDSC), and actigraphy when available; targeted sleep hygiene and behavioral strategies were implemented before and during PedPRM. (1) An 8-year-old boy with ADHD on extended-release methylphenidate had persistent sleeponset insomnia and fragmented sleep; PedPRM 2 mg nightly reduced sleep latency and nocturnal awakenings, consequently improving emotional regulation and daily attention, with stable benefit at 3–6 months. (2) A 4-year-old girl with ASD had long nighttime awakenings despite 4 mg immediate-release melatonin; switching to PedPRM 2→5 mg reduced latency, greatly shortened the prolonged awakening, and improved daytime irritability. (3) An 8-year-old boy with severe ASD and epilepsy had nightly 3–5 h awakenings unresponsive to behavioral measures or immediaterelease melatonin; PedPRM 3 mg markedly reduced the awakenings; discontinuation led to relapse and re-initiation restored benefit. (4) A 14-year-old girl with ASD and ADHD presented sleep-onset insomnia and nocturnal awakenings unresponsive to sleep hygiene and behavioral techniques; 3 mg PedPRM reduced sleep latency and nocturnal awakenings. Conclusions: These cases support randomized studies showing PedPRM is effective and safe in ASD and/or ADHD, consistent with European guidelines for insomnia related to these conditions when sleep hygiene fails. PedPRM is an option if behavioral strategies do not address sleep-onset or maintenance issues.

Keywords:

Autism spectrum disorder; ADHD; Pediatric insomnia; Melatonin; Prolongedrelease

Cite the Article:

Mammarella V, Breda M, Ferri R, Bruni O. Prolonged-Release Melatonin for Pediatric Insomnia in Autism and/or ADHD: A Four-Case Series. Ann Clin Case Rep. 2025; 10: 2802..