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MHRA approves Colonis’s Melatonin to treat sleep onset insomnia in children


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Colonis, a subsidiary company of the Clinigen Group has received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD).

Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia.

Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children. The prevalence of sleep onset insomnia in children with ADHD ranges from 25%-50%. Sleep onset insomnia in children with ADHD can affect their mood, attention, behaviour and school performance.

Dr Henno Welgemoed

Henno Welgemoed, Director of Medical Affairs at Colonis 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 while supporting Clinigen Group’s mission to deliver the right medicine to the right patient at the right time.”


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