Why Slenyto® ?
About Slenyto® l Dosing & Administration l Slenyto® Clinical Evidence l Slenyto® Safety
Slenyto® Clinical Evidence
Slenyto® efficacy was demonstrated in a randomized placebo-controlled, multi-center confirmatory, Phase III trial conducted in 4 countries including 125 pediatric ASD with and without ADHD and SMS patients. Patients were aged 2-18 year old and were treated with either Slenyto® (60 patients) or placebo (65 patients) for a period of 13 weeks, followed by a long term follow up (91 weeks) in which all patients were treated with Slenyto® (total of 2 years) with additional 2 weeks placebo run-out period.
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28.8% of participants had comorbid ADHD, and 12.8% participants had comorbid epilepsy. Prior ADHD treatment was reported by 10.4% of the participants, antidepressant by 8%, anti-epileptics by 6.4%, clonidine by 5.6%, and β-blockers by 0.8%.
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The study was successfully completed demonstrating Slenyto® efficacy in improving children sleep variables (sleep onset, maintenance and total sleep time), children daytime behavior and parents well-being , both in the short- and long-term, demonstrating Slenyto® ability to provide patients with Good Nights and Better Days.
Slenyto® Benefits
Improves sleep onset latency, sleep maintenance and total sleep time
Improves child’s externalizing behaviors (hyperactivity/inattention and conduct)
Improves parents/caregivers quality of Life
Improves child quality of life
Dose adjustable - 1 mg, 2mg, 5mg, 10mg
Benefit was similar in all trail age groups
Compliance was close to 100% throughout the study
Sleep Benefits
Slenyto®’s prolonged-release properties improve both sleep initiation and sleep duration, resulting in increased total sleep time without early awakenings.
Slenyto® improves sleep parameters
Total Sleep Time (TST)
Sleep Latency (SL)
†T-test.
Slenyto® significantly improved both TST and SL vs placebo by Week 13 in the subgroup* of children with ADHD symptoms (n=78)
* Baseline SDQ hyperactivity score ≥7.
Behaviour Benefits
Slenyto® improves externalizing behavior and inattention as well as the QoL of the child and the parent.
Better sleep leads to better behavior and social functioning
SDQ externalising factor
score change from baseline
SDQ total difficulties score
change from baseline
*T-test.
Baseline SDQ hyperactivity score >7
Slenyto® significantly improved SDQ hyperactivity score vs placebo by Week 13 in the subgroup of children with ADHD symptoms (n=73)
References: 1. Gringras P, et al., J Am Acad Child Adolesc Psychiatry, 2017; 56(11):948-957.e4; 2.Maras A., et al.,J Child Adolesc Psychopharmacol, 2018;doi: 10.1089/cap.2018.0020; 3. Gringras., P et al.,BMJ , 2012; 345:e6664; 4. Schroder, C. M. et al., Expert Opin Pharmacother. 2021;22(18):2445-2454; 5.https://www.ema.europa.eu/documents/product-information/slenyto-epar-product-information_en.pdf ; 6. Van der Heijden, Kristiaan B et al., J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):233-41.; 7. Slenyto assessment report 30 January 2025 EMA/119604/2025 Committee for Medicinal Products for Human Use (CHMP).