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New HTA Decisions in Scotland
March 2021
Drug name
SLENYTO® (melatonin prolonged-release)
Company
Flynn Pharma Ltd
Decision date
04/12/2020
Therapeutic area
Neurological conditions
Therapeutic sub area
Neurological conditions: general and other
Therapeutic area 2
Mental health and behavioural conditions
Therapeutic sub area 2
Autism
Decision
Not recommended
Indication
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.
Decision Detail
Following a resubmission, melatonin prolonged-release (SLENYTO®) is not recommended for use within NHS Scotland.
Summary
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.