following a resubmission:
melatonin prolonged-release (Slenyto®) is not recommended for use within NHSScotland.
Indication under review: Treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
Melatonin prolonged-release (Slenyto®), compared with placebo, increased total sleep time and sleep onset latency in children aged 2 to 17.5 years with sleep problems and autism spectrum disorder and / or Smith-Magenis syndrome who had an insufficient response to sleep hygiene measures.
The company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Medicine details
- Medicine name:
- melatonin (Slenyto)
- SMC ID:
- SMC2306
- Indication:
For the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
- Pharmaceutical company
- Flynn Pharma Ltd
- BNF chapter
- Central nervous system
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 18 January 2021