About Slenyto®

​​Slenyto® indication

Slenyto® is indicated for the treatment of insomnia in children and adolescents aged 2-18 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. 
Slenyto® is also indicated for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

 

 

Slenyto® in NGDs

Slenyto® has been shown to be effective at improving sleeping time in children and adolescents with ASD,  Neurogenetic Disorders (e.g. Smith-Magenis Syndrome, a neurogenetic disorder associated with an abnormal production of melatonin) or ADHD.

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Data from the medical literature show that children and adolescents with neurogenetic disorders have problems with the production of melatonin, which can lead to sleep disturbances. Data also indicate that melatonin may improve the sleep pattern of these children when keeping to a regular sleeping routine did not work. It is therefore likely that the prolonged-release melatonin in Slenyto® will help them with falling asleep and staying asleep.

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A large study with Slenyto® was done involving 125 patients from 2 to 17 years of age, including 121 with ASD, 36 of whom also had ADHD,  and 4 with Smith-Magenis Syndrome (NGD). All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work. During a 13 weeks treatment period, patients given Slenyto® slept on average 51 additional minutes per night compared with 19 additional minutes for those given placebo (a dummy treatment). In addition, children who took Slenyto® fell asleep around 38 minutes earlier than usual while those taking placebo fell asleep 13 minutes earlier. 

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​​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 Neurogenetic Disorders (NGDs) and/or Attention-Deficit Hyperactivity Disorder (ADHD). 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.

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Slenyto® was developed especially for children, based on an agreed pediatric investigation plan (PIP) for the treatment of insomnia in ASD children with and without ADHD and tested in several clinical trials, including a 2 years, Phase III study in 24 leading pediatric neurology/psychiatry centers in the US and Europe. 

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​​Slenyto® mechanism of action & pharmacokinetics

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

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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.