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.
Figure 3. Slenyto (Paediatric Prolonged-Release
Melatonin Tablets) 1mg and 5mg
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.1
References:
13. Slenyto® SmPC Accessed August 2025