Slenyto

Posology Insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings The recommended starting dose is 2 mg of Slenyto.

If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg. 5-1 hour before bedtime and with or after food. Data are available for up to 2 years’ treatment. The patient should be monitored at regular intervals (at least every 6 months) to check that Slenyto is still the most appropriate treatment.

After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. If a lower treatment effect is seen after titration to a higher dose, the prescriber should first consider a down-titration to a lower dose before deciding on a complete discontinuation of treatment.

If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose. Insomnia in children and adolescents aged 6-17 years with ADHD The recommended starting dose is 1-2 mg.

The dose may be adjusted on an individual basis to 5 mg per day regardless of age of the child. If clinically needed, the maximum daily dose may be increased to 10 mg. The lowest effective dose should be taken for the shortest period.

5-1 hour before bedtime and with or after food. After approximately 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. The patient should be monitored regularly (at least every 6 months) to check that Slenyto is still the most appropriate treatment.

During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly, at least once a year. If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose.

Special populations Renal impairment The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied. Caution should be used when melatonin is administered to patients with renal impairment. Hepatic impairment There is no experience of the use of melatonin in patients with liver impairment.

Summary of the safety profile The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 children. Tabulated list of adverse reactions Adverse reactions are listed according to MedDRA system organ class and frequency category.

Frequency categories are defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

7 System Organ Class Common Psychiatric disorders Mood swings, Aggression, Irritability Nervous system disorders Somnolence, Headache, Sudden onset of sleep Respiratory, thoracic and mediastinal disorders Sinusitis General disorders and administration site conditions Fatigue, Hangover The following adverse reactions (frequency unknown) have been reported with off-label use of the adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal behaviour and neutropenia.

Furthermore, in ASD and neurogenetic children treated with 2-6 mg of the adult formulation under a Temporary Recommendation for Use (RTU) program in France (N=926), the following additional adverse reactions (frequency uncommon) have been reported: depression, nightmares, agitation and abdominal pain.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Drowsiness Melatonin may cause drowsiness and residual effects such as daytime fatigue may occur. These effects should be considered, particularly in children and adolescents with ADHD, as they may exacerbate daytime symptoms like inattention, hyperactivity, or behavioural disturbances.

Caregivers and healthcare professionals should monitor patients for signs of daytime fatigue and adjust the dosing schedule or discontinue treatment if such effects impair daily functioning. 7). Autoimmune diseases No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases.

Therefore, melatonin is not recommended for use in patients with autoimmune diseases. 5). Lactose Slenyto contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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