Adaflex: first UK-licensed melatonin for children with insomnia and ADHD

The first licensed melatonin treatment for children and adolescents with insomnia linked to ADHD has been approved for use in the UK. The drug known as Adaflex, will for the first time provide a regulated option for families seeking effective sleep support for children with attention deficit hyperactivity disorder (ADHD).

What is Adaflex?

Adaflex is a prolonged-release melatonin tablet designed for children aged six to 17 who struggle with sleep disturbances due to ADHD. Previously, families in the UK have had to rely on unlicensed melatonin supplements, but Adaflex is a fully licensed treatment, ensuring a consistent dosage, safety standards and regulatory approval.

The approval of Adaflex marks a significant milestone in paediatric sleep management as it provides a clinically tested alternative to commonly used but unregulated melatonin products.

Why is Adaflex important for ADHD-related insomnia?

Children with ADHD frequently experience sleep disturbances, leading to difficulty falling asleep and staying asleep. Poor sleep can exacerbate ADHD symptoms, affecting concentration, mood ang general wellbeing.

Clinical studies have shown that melatonin can help regulate sleep patterns in children with ADHD. However, AGB-Pharma, the Swedish pharmaceutical company that produced Adaflex, estimates that around 60 percent of all melatonin prescriptions are dispensed to under 18s off-label or unlicensed. Its data identified that half of GPs are reluctant to prescribe these products, meaning prescription responsibilities are instead placed with overstretched specialists.

How is Adaflex different from other melatonin products?

Many melatonin supplements available in the UK are unlicensed, meaning they lack regulatory oversight regarding dosage consistency, manufacturing quality and safety. The benefits of Adaflex include:
• It’s available in a range of doses (1mg, 2mg, 3mg, 4mg and 5mg), negating the need to split or halve pills for younger or smaller patients
• It’s licensed and regulated for use in children and adolescents
• The treatment has been clinically tested for ADHD-related insomnia
• The drug is prescribed by doctors, ensuring patients have access to the correct dosage and usage plans.

“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,” AGB-Pharma CEO Fredrik Lindberg 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,” AGB-Pharma CEO Fredrik Lindberg shared.