The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Melatonin prolonged-release (Slenyto®) has been rejected following a resubmission for use in the 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. The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.