MHRA approves ADHD treatment for children with insomnia

Child with insomnia

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.1 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.2,3,4,6

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. Park HS, Joo EY, Hong SB, Sleep onset insomnia. J Korean Sleep Res Soc. 2009;6(2):74-85
  2. 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
  3. Bendz LM, Scates AC. Melatonin Treatment for Insomnia in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder. Ann Pharmacother. 2010 Jan;44(1):185-91
  4. Cortese S, Vincenzi B, Angriman M. Identifying and managing sleep disorders associated with ADHD. Neuropsychiatry. 2012;2(5):393–405
  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. 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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