MHRA approves treatment that helps ADHD children and adolescents who experience sleep onset insomnia

[UK] / [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.

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.

Sleep onset insomnia is a sleep disorder characterised by difficulty falling asleep.² Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children.^3,4 The prevalence of sleep onset insomnia in children with ADHD ranges from 25%-50%.⁵ Sleep onset insomnia in children with ADHD can affect their mood, attention, behaviour and school performance.^6,7,8,9

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.”

Research published in the Journal of the American Academy of Child and Adolescent Psychiatry examined Melatonin in a 4-week randomised, double-blind, placebo-controlled study.⁹ It was conducted on 105 children between 6 and 12 years of age with ADHD and chronic sleep onset insomnia. Participants received melatonin (3 mg when body weight <40 kg [n = 44]; or 6 mg when body weight >40 kg [n = 9]) in fast-release tablets or placebo.

Sleep onset advanced by 26.9 ± 47.8 minutes with Melatonin, whereas there was a delay of 10.5 ± 37.4 minutes with placebo (p < 0.0001). 48.8% of children who received Melatonin showed an advance of sleep onset >30 minutes compared to 12.8% with placebo (p = 0.001). There was an increase in mean total time spent asleep of 19.8 ± 61.9 minutes with Melatonin and a decrease of 13.6 ± 50.6 minutes with placebo (p = 0.01).⁹

Compared with the placebo, the melatonin group showed a significant decrease in sleep latency (p = 0.001) and an increase in sleep efficiency (p = 0.01). The mean score on sleep log item difficulty falling asleep decreased by 1.2 ± 1.3 points (35.3% of baseline) with Melatonin and by 0.1 ± 0.8 points (4.3% of baseline) with placebo (p < 0.0001).⁹