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The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.
Colonis, a subsidiary company of the Clinigen Group, announced on Oct. 4, 2022 that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its melatonin 1mg/mL oral solution for sleep onset insomnia in children and adolescents aged 6–17 years with attention-deficit hyperactivity disorder (ADHD).
According to a company press release, 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% and can affect their mood, attention, behavior, and school performance.
“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,” said Henno Welgemoed, director of medical affairs at Colonis, in the release. “This approval provides a valuable treatment option for children and adolescents suffering with ADHD and sleep onset insomnia, adding further breadth to Colonis’ growing pediatric portfolio while supporting Clinigen Group’s mission to deliver the right medicine to the right patient at the right time.”