The MHRA has approved a melatonin 1mg/ml oral solution for sleep onset insomnia in children and adolescents aged between six and 17 with ADHD where sleep hygiene measures have been inadequate.

Manufacturer Colonis, which is based in Weybridge and is a subsidiary of the Clinigen Group, said clinical evidence had demonstrated melatonin’s potential “to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia”.

Research published in the Journal of the American Academy of Child and Adolescent Psychiatry found that over a four-week period melatonin helped bring forward sleep onset and increase the total time spent asleep for children with ADHD and insomnia, while children in the placebo group saw their sleep deteriorate further.

Colonis medical affairs director Henno Welgemoed said: “We welcome the MHRA’s approval for a condition that negatively affects the quality of life for children and adolescents diagnosed with ADHD and increases the burden for support networks.

“This approval provides a valuable treatment option for children and adolescents suffering with ADHD and sleep onset insomnia, adding further breadth to Colonis’ growing paediatric portfolio.”