First UK-licensed melatonin for children with insomnia and ADHD

Adaflex, the UK’s first melatonin product for six to 17 year-olds diagnosed with ADHD and insomnia (where sleep hygiene measures have been inadequate), is now available in the UK.

Melatonin is commonly used to treat insomnia. However until now, prescribing a treatment for children with ADHD has been off-label or unlicensed in the UK. AGB-Pharma, the Swedish pharmaceutical company that produced the drug, predicted around 60 percent of all melatonin prescriptions are dispensed to under 18s off-label or unlicensed. Its data identified half of GPs are reluctant to prescribe these products, meaning prescription responsibilities are instead placed with overstretched specialists.

AGB determined through analysis of UK National Health Service (NHS) prescription data that if every prescribed melatonin product was for Adaflex, the NHS could save just under £11 million annually.

AGB-Pharma CEO Fredrik Lindberg added: “It is hoped that now a licensed medication for children and adolescents is available, shared care agreements between primary and secondary care will be possible in more cases, streamlining the patient care pathway.”

Dr María Martínez Hervés, Consultant Child and Paediatric Psychiatrist commented: “…sufficient good quality sleep can be a struggle for children with ADHD… Having a licensed melatonin product could ease the transition of patients from a specialist service to general practice.”

Research estimated 73 percent of children with ADHD will experience sleep problems and poor sleep can worsen ADHD symptoms. The UK National Institute of Health and Care Excellence (NICE) found that 87.8 percent of parents who treated their child with melatonin consider it helpful for inducing sleep. Thus, wider access to the drug is much needed and welcomed by the patient community.

Adaflex is available in a range of doses (1mg, 2mg, 3mg, 4mg and 5mg), unlike other melatonin products. Traditionally, intermediate doses of melatonin products must be split or halved to be used, so AGB’s novel medicine can simplify the process.