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Frequently Asked Questions

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Here is a list of commonly asked questions you or your patients may have about their child’s insomnia-related symptoms and treatment. 

Click on any of the questions below to expand the answer

  • What is Slenyto?
    Slenyto is a prescription medicine used to treat insomnia in children with ASD and/or SMS, aged 2-18. Slenyto is a 3mm diameter minitablet of prolonged-release melatonin, taken every night, 30-60 minutes before bed time at the appropriate dosage. Slenyto has demonstrated significant clinical benefits in a Phase III study that have led to its approval by EMA. Press here, for more on Slenyto clinical evidence & safety.
  • Why choose Slenyto for your pediatric ASD insomnia patients?
    Slenyto is the only approved medication for the treatment of insomnia in ASD and / or SMS children and adolescents. Slenyto has a prolonged release profile that mimics endogenous melatonin secretion. It has a well-defined pharmaceutical characterization and is manufactured in accordance with the highest requirements. Slenyto has been designed especially for children, it is 3mm diameter coated mini tablet, odorless and tasteless.
  • What are the clinical benefits of Slenyto on child’s sleep?
    Slenyto prolonged release formulation achieves a therapeutically effective concentration of melatonin in the systemic circulation throughout the night and thus only Slenyto significantly improves sleep latency, sleep maintenance and total sleep time without causing early awakenings. Press here, for more on Slenyto clinical evidence .
  • Does Slenyto have an impact on child’s behavior?
    Only Slenyto is proven to significantly improve child's behavior and social functioning also resulting in improved parents’ well-being. Press here, for more on Slenyto clinical evidence
  • Is it easy to swallow Slenyto?
    Slenyto has been developed specifically for children with ASD, it is extremely small (3mm diameter) minitablet, which is tasteless and odorless to fit children, particularly young children, and children with swallowing difficulties. Press here, for more on Slenyto Dosage & Administration . During the clinical trials close to 100% of children were compliant to treatment.
  • What dosages are available and how to choose the right dose?
    Slenyto is available in two dosage forms - 1mg (pink minitablet) and 5mg (yellow minitablet). The recommended starting dose is 2mg (2 x 1mg). You may increase Slenyto dose to 5mg (1 x 5mg yellow minitablet) or 10mg (2 x 5mg yellow minitablet) according to patient individual response. Press here, for more on Slenyto Dosage & Administration
  • What are the treatment options for Pediatric Insomnia?
    Sleep hygiene is a non-pharmacological approach that is recommended for insomnia in children before trying any pharmacological therapy. It includes behavioral and environmental practices that are intended to promote better sleep. In 25% of cases sleep hygiene might be effective, but if sleep hygiene does not work, pharmacological therapy could be initiated. Slenyto (prolonged release melatonin) is the only pharmacotherapy approved for the treatment of insomnia in ASD and SMS.
  • Is Slenyto different from immediate release melatonin?
    Yes, Slenyto is different from immediate release melatonin. Slenyto mimics endogenous melatonin secretion and maintains elevated melatonin levels throughout the night. By mimicking the endogenous melatonin secretion profile, only Slenyto is clinically proven to improve daytime behavior, all main sleep variables (sleep onset, sleep maintenance ,total sleep time) and parents’ well-being. This is in contrast to immediate release melatonin, which shortens sleep onset latency and causes early awakening.
  • How is Slenyto administered?
    Slenyto should be taken daily, at night, 30-60 minutes before bedtime. Slenyto may be taken with a glass of water or be put into food such as yogurt, orange juice or ice-cream to help with swallowing. It should not be crushed or chewed. If the child misses a dose of Slenyto, it could be taken before they go to sleep that night but after this time, no other Slenyto tablet should be taken before the next evening. Press here, for more on Slenyto Dosing & Administration
  • What are some possible adverse reactions of Slenyto?
    The safety profile of Slenyto was established in the longest clinical trial program in Pediatric ASD. Slenyto offers favorable safety, both short and long term. Mood swings, aggression, irritability somnolence, headache, sudden onset of sleep, sinusitis, fatigue, and hangover occurred in 1:10-1:100 children. Overall, similar treatment-related side effects in Slenyto and placebo groups, except mild to moderate somnolence, which was more common with Slenyto. The occurrence of side effects was lower with long term use of Slenyto and there were no reports of dependence, abuse, tolerance, withdrawal or rebound. Compliance with the Slenyto mini-tablets was close to 100% throughout the 24 months study. For detailed information, please see the Patient Information Leaflet.
  • How is Slenyto stored?
    Slenyto should be stored below 30°C and out of the sight and reach of children.
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