Advice

following a full submission:

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 submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.  

The license holder has indicated their intention to resubmit.

 

 

Medicine details

Medicine name:
melatonin (Slenyto)
SMC ID:
SMC2168
Indication:

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
Full
Status
Not recommended
Date advice published:
09 September 2019