Pediatric prolonged-release melatonin for insomnia in children and adolescents with autism spectrum disorders

Introduction: Insomnia is common among children and adolescents with Autism spectrum disorder (ASD). The first drug licensed for insomnia in this population, a pediatric-appropriate prolonged-release melatonin (PedPRM) formulation is described. Areas covered: Literature search on PedPRM efficacy and safety profile in clinical trials, and a proposed decision-making algorithm to optimize outcome in the treatment of insomnia in children and adolescents with ASD. Expert opinion: PedPRM treatment effectively improves sleep onset, duration and consolidation, and daytime externalizing behaviors in children and adolescents with ASD and subsequently caregivers’ quality of life and satisfaction with their children’s sleep. The coated, odorless and taste-free mini-tablets are well-accepted in this population who often have sensory hypersensitivity and problems swallowing standard tablet preparations. The most frequent long-term treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%) with no evidence of delay in height, BMI, or pubertal development, or withdrawal effects. The starting dose is 2 mg once daily independent of age or weight, escalated to 5–10 mg/day if predefined treatment success criteria are unmet. Slow melatonin metabolizers (~10% of children), may require lower doses. Given its long-term efficacy, safety and acceptance, PedPRM may ameliorate long-term consequences of insomnia in this population.

Prolonged-release melatonin, adolescent, autism spectrum disorder, child, insomnia

10.1080/14656566.2021.1959549

1465-6566

2445-2454

Schroder, Carmen M.

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Banaschewski, Tobias

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Fuentes, Joaquin

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Hill, Catherine Mary

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Hvolby, Allan

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Posserud, Maj-Britt

24535e0f-04e0-41ed-9507-f8634793f377

Bruni, Oliviero

e215d61e-95bc-4305-a978-1b312faeced3

12 December 2021

Schroder, Carmen M.

e586804c-c2a6-422a-8e32-dc50d783e15a

Banaschewski, Tobias

740d3bed-81c1-4d26-b3f0-42866cd5307e

Fuentes, Joaquin

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Hill, Catherine Mary

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Hvolby, Allan

c5c5ae11-7629-4064-bf43-f0ef265c42b1

Posserud, Maj-Britt

24535e0f-04e0-41ed-9507-f8634793f377

Bruni, Oliviero

e215d61e-95bc-4305-a978-1b312faeced3

Schroder, Carmen M., Banaschewski, Tobias, Fuentes, Joaquin, Hill, Catherine Mary, Hvolby, Allan, Posserud, Maj-Britt and Bruni, Oliviero (2021) Pediatric prolonged-release melatonin for insomnia in children and adolescents with autism spectrum disorders. Expert Opinion on Pharmacotherapy, 22 (18), 2445-2454. (doi:10.1080/14656566.2021.1959549).

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Accepted/In Press date: 20 July 2021

Published date: 12 December 2021

Additional Information: Funding Information: All authors received personal fees and non-financial support from Neurim Pharmaceuticals SARL for a videoconference consensus meeting and coverage of the journal?s submission fees related to the paper under consideration for publication. Funding Information: C Schroder has served in an advisory or consultancy role for Neurim pharmaceuticals related to the work under consideration for publication and reports personal fees and non-financial support from Biocodex for expert group and lectures, travel to meetings and personal fees from Takeda for lecture outside the submitted work. T Banaschewski has served in an advisory or consultancy role for ADHS digital, Infectopharm, Lundbeck, Medice, Oberberg GmbH, Neurim Pharmaceuticals, Roche, and Takeda. They received conference support or speaker’s fee by Medice and Takeda. Received royalities from Hogrefe, Kohlhammer, CIP Medien, Oxford University Press; the present work is unrelated to these relationships. J Fuentes has received research support from Policlinica Gipuzkoa Foundation (PGF), Servier, and AIMS-2 Trials (Project ID 777,394). They have received partial support for professional meetings attendance from PGF, ESCAP & AACAP. MB Posserud meanwhile reports Scientific Advisory Board meeting reimbursement from Takeda paid to their institution, outside the submitted work. Finally, O Bruni has served in an advisory or consultancy role for Neurim pharmaceuticals related to this work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Keywords: Prolonged-release melatonin, adolescent, autism spectrum disorder, child, insomnia