Weybridge-based pharmaceutical company Colonis, a subsidiary company of the Clinigen Group, have announced that the MHRA has approved Colonis’ Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate.
Key highlights:
- The MHRA has approved Colonis' Melatonin to help ADHD children and adolescents with sleep onset insomnia get a good night’s sleep.
- Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD.
- Melatonin has the potential to ease the burden of the debilitating symptoms of sleep onset insomnia for children and adolescents with ADHD, and improve the lives of their families.
The official regulator’s decision means that a fully licensed version of the treatment is now available for the first time.
Clinical research published in the Journal of the American Academy of Child and Adolescent Psychiatry showed that Melatonin increased the onset of sleep and the total amount of time spent asleep; it also decreased sleep latency and improved sleep efficacy.
Melatonin has the potential to significantly ease the burden of the debilitating symptoms of sleep onset insomnia for children and adolescents with ADHD, and improve the lives of their families. This significantly impacts the mood, attention, behaviour and school performance of those affected.
Sleep onset insomnia is a sleep disorder characterised by difficulty falling asleep. 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.
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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