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MHRA approves treatment for sleep onset insomnia in children with ADHD

Colonis, a subsidiary company of the Clinigen Group, have announced that the Medicines and Healthcare products Regulatory Agency (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 asleep2. Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children3,4. 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 performance6,7,8,9.

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 study9. 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.

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.”


1 Colonis Pharma Limited. Melatonin 1 mg/ ml oral solution. Summary of Product Characteristics. Revision date: September 2022

2 Park HS, Joo EY, Hong SB, Sleep onset insomnia. J Korean Sleep Res Soc. 2009;6(2):74-85

3 Wajszilber D, Santiseban JA, Gruber R. Sleep disorders in patients with ADHD: impact and management challenges. Nat Sci Sleep. 2018; 10: 453–480

4 Bruni O, Alonso-Alconada D, Besag F, et al. Current role of Melatonin in pediatric neurology: clinical recommendations. Eur J Paediatr Neurol. 2015 Mar;19(2):122-33

5 Abdollahian E, Mohareri F. Evaluation of the Effect of Melatonin On Improvement of Sleep Quality in Children with Attention Deficit/hyperactivity Disorder Whom Received Ritalin. European Psychiatry. 2015;30(S1): 1-1

6 Abramova R, Campbell P, Baron J, Patel K, Parmar S. Review of Melatonin Supplementation for Sleep Disorders in Pediatric Special Populations. J Pharm Pract. 2020 Aug;33(4):533-539

7 Bendz LM, Scates AC. Melatonin Treatment for Insomnia in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder. Ann Pharmacother. 2010 Jan;44(1):185-91

8 Cortese S, Vincenzi B, Angriman M. Identifying and managing sleep disorders associated with ADHD. Neuropsychiatry. 2012;2(5):393–405

9 Van der Heijden KB, Smits MG, van Someren EJW, et al. Effect of Melatonin on sleep, behavior, and cognition in ADHD and chronic sleep-onset insomnia. J Am Acad Child Adolesc Psychiatry. 2007;46(2):233-241

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Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.


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