Slenyto
Slenyto is a pediatric-focused, prolonged-release formulation of melatonin. It mimics the natural release pattern of melatonin in the body to help children and adolescents with neurodevelopmental disorders initiate and maintain sleep throughout the night.
Dosage by Body Weight
Take once daily, 30-60 minutes before bedtime with or after food. The tablets must be swallowed whole to maintain the prolonged-release properties; they should not be crushed, broken, or chewed. Starting dose is typically 2 mg, which may be increased up to a maximum of 10 mg based on clinical response.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Slenyto is not indicated for children under 2 years of age.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Slenyto is not indicated for children under 2 years of age.
- Body Weight
- 8-10 kg
- Dose
- 2 mg
- Frequency
- Once daily before bedtime
- Tracking Notes
- Only for children aged 2 years and older as prescribed by a healthcare provider.
- Body Weight
- 11-15 kg
- Dose
- 2 mg to 5 mg
- Frequency
- Once daily, 30-60 minutes before bedtime
- Tracking Notes
- Standard pediatric starting dose is 2 mg. May be titrated up to 5 mg if clinical response is insufficient.
- Body Weight
- 16-20 kg
- Dose
- 2 mg to 5 mg
- Frequency
- Once daily, 30-60 minutes before bedtime
- Tracking Notes
- Dose is adjusted based on clinical response, up to a maximum of 10 mg daily under specialist supervision.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | N/A | Slenyto is not indicated for children under 2 years of age. |
| 5-7 kg | Not recommended | N/A | Slenyto is not indicated for children under 2 years of age. |
| 8-10 kg | 2 mg | Once daily before bedtime | Only for children aged 2 years and older as prescribed by a healthcare provider. |
| 11-15 kg | 2 mg to 5 mg | Once daily, 30-60 minutes before bedtime | Standard pediatric starting dose is 2 mg. May be titrated up to 5 mg if clinical response is insufficient. |
| 16-20 kg | 2 mg to 5 mg | Once daily, 30-60 minutes before bedtime | Dose is adjusted based on clinical response, up to a maximum of 10 mg daily under specialist supervision. |
Formulation
Purpose
Treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
Generic Name
MelatoninScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.