Pediatric Appropriate Prolonged-Release Melatonin Minitablet for Insomnia in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Case Reports

Delorme Richard, Fefeu Mylene, Moscoso Ana, Acquaviva Eric, Chavand-Gassier Aurelie, Lecendreux Michel, Lanco Dosen Sandrine and Schroder Carmen

Department of Child and Adolescent Psychiatry, Robert Debré University Hospital, Child brain institute, Paris Cité University, APHP, Paris, France Avenue Olbius Riquier 83400 Hyères, France Pediatric Sleep Center, Robert Debré University Hospital, AP-HP, Paris Cité University, Paris, France. Hospital Center de Sambre - Avesnois (MAUBEUGE) (Centre hospitalier (Maubeuge) Maubeuge) Department of Child and Adolescent Psychiatry, Excellent Centre for Neurodevelopmental Disorders STRAS&ND, International Research Centre for ChronoSomnology (CIRCSom), Strasbourg University Hospital, Strasbourg, France

^*Correspondance to: Schroder Carmen 

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Abstract:

Despite high rates of sleep impairments among children and adolescents with attention-deficit/ hyperactivity disorder (ADHD), and its negative impact on child development, behavior, health and quality of life, there is limited awareness among clinicians of screening for and treatment of insomnia in this population. Pediatric Prolonged-Release Melatonin (PedPRM, Slenyto®) is the first authorized drug for the management of insomnia in children and adolescents (aged 2-18) with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) and it is now approved for children and adolescents (aged 6-17) with ADHD, but there is little evidence on how it may act on ADHD related symptoms and insomnia in real life treatment. This case series reports 12 children and adolescents (aged 6-13 years) with ADHD and insomnia, and describes the decision-making process involved in PedPRM selection and treatment optimization. Some patients initiated cognitive behavioral therapy and/or immediate release (IR) melatonin as a first line treatment for their insomnia, with no or partial success. The administration of PedPRM, followed by dose optimization resulted in 9 patients attaining acceptable sleep duration (>7 h), sleep maintenance (longest sleep episode >6 h) and sleep initiation (sleep onset latency <30 min). The other 3 patients attained acceptable sleep in two out of the 3 variables. Significant positive effects on daytime behavior and parent satisfaction were noted in all reported cases. Thus, real life evidence supports PedPRM as an effective and safe strategy for managing insomnia in pediatric patients with ADHD.

Keywords:

hyperactivity disorder

Cite the Article:

Richard D, Mylene F, Ana M, Eric A, Aurelie C-G, Michel L. Pediatric Appropriate Prolonged-Release Melatonin Minitablet for Insomnia in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Case Reports. Ann Clin Case Rep. 2025; 10: 2762..