Why Slenyto® ?
About Slenyto®â€‹
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), Neurogenetic Disorders (NGDS) and 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 and tested in several clinical trials, including a 2 years, Phase III study in 24 leading pediatric ASD centers in the US and Europe.
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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.
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® 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.
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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, NGDs and ADHD 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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Consequently, Slenyto® treatment holds a major advantage over IR melatonin formulations as it not only improves sleep-onset latency (as is the case for IR melatonin), but it also improves sleep maintenance and sleep duration. Total sleep time (TST) and longest sleep period (sleep maintenance) are the variables that are associated with daytime behaviour.
References: 1. https://www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf; 2. Zisapel, N., Open Neuroendocrinology Journal, 2010; 3:85-95; 3. Schroder, C. M. et al., Expert Opin Pharmacother. 2021;22(18):2445-2454; 4. Stott, J., E. Coleman, A. Hamilton, J. Blackwell and H. L. Ball (2023). "Exploring the Longitudinal Relationship Between Short Sleep Duration, Temperament and Attention Deficit Hyperactivity Disorder Symptoms in a Biethnic Population of Children Aged Between 6 and 61 Months: A Born in Bradford Study." J Atten Disord 27(9): 929-938.