ASD

Insomnia in Children with ASD: Slenyto^® Paediatric Prolonged-Release Melatonin Tablets

In September 2018, Slenyto 1mg and 5mg Tablets (mini-tablets), an age and condition-appropriate paediatric formulation of prolonged-release melatonin for the treatment of insomnia in children with Autistic Spectrum Disorder and/or Smith-Magenis Syndrome, were granted Marketing Authorisations (MAs).

In June 2025, the indication for Slenyto was extended to include:

Treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and/or neurogenetic disorders  with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient.
Treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

At 13 weeks

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57.5

Minutes longer
per night

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39.6

Minutes earlier
to fall asleep

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68.9%

Responded
Clinically

At 52 weeks

Minutes longer
per night

Minutes earlier
to fall asleep

Minutes longer
LSE

All images relative size

Figure 3. Slenyto (Paediatric Prolonged-Release Melatonin Tablets) 1mg and 5mg

A guide for parents and caregivers of children prescribed Slenyto can be accessed here

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Circadin® (prolonged-release melatonin 2mg indicated for treatment of primary insomnia in patients >55) is not an appropriate product for this patient population.

Slenyto has a Paediatric-Use Marketing Authorisation (PUMA) and is formulated to be both condition (ASD) and age (2-18 years) appropriate. Slenyto mini-tablets (1mg and 5mg) are 3mm in diameter (see Figure 3 - not actual size), flavourless and odourless and the strengths are differentiated by colour. The Summary of Product Characteristics provides further information on co-administration with foodstuffs to facilitate swallowing and improve compliance.¹³