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About Slenyto®

Slenyto® is designed with children in mind

Slenyto® is the first and only pharmacotherapy approved for the treatment of insomnia in children with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS). Slenyto® is a prolonged-release melatonin minitablet, only 3 mm diameter. It is tiny, odorless and tasteless to ensure easy swallowing and adherence to treatment even in children as young as 2 y/o.

Slenyto® was developed especially for children, based on an agreed pediatric investigation plan (PIP) for the treatment of insomnia in ASD children and tested in several clinical trials, including a 2 years, Phase III study in 24 leading pediatric ASD centers in the US and Europe. 

Slenyto® indication

Slenyto® is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS), where sleep hygiene measures have been insufficient.



Slenyto® mechanism of action & pharmacokinetics

Slenyto® is a prolonged-release melatonin formulation that mimics endogenous melatonin secretion, maintaining elevated melatonin levels throughout the night. 

In a paediatric population comprising 16 ASD children ages 7-15 years old suffering from insomnia, following Slenyto® 2 mg (2 x 1 mg minitablets) administration, melatonin concentrations peaked within 2 hours after administration and remained elevated for 6 hours thereafter for a total of 8 hours to achieve a therapeutically effective concentration of melatonin in the systemic circulation through the night.


Slenyto® mimics the endogenous profile in a healthy young child . In contrast, Immediate-Release Melatonin has a short half-life of 40 minutes , therefore high doses or repeated administrations are needed to cover the whole night.

Slenyto mimics endogenous melatonin secretion, preserving physiological sleep pattern

Slenyto® Benefits for your patient and his family

Slenyto® improves all main sleep parameters: sleep onset latency, sleep maintenance and total sleep time.

Slenyto® is the only melatonin product that improves daytime behavior. 

Slenyto® is designed specifically for children with ASD and SMS to ensure easy intake with high efficacy and safety.

The beneficial effects of Slenyto® on sleep and daytime behavior result in improved parents' satisfaction and quality of life.

Slenyto® offers flexible dosing that can be optimized according to the child's response and  treatment goals.

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