MHRA approved melatonin treatment for children with ADHD and sleep onset insomnia

According to a recent announcement, the UK Medicines and Health Products Regulatory Agency (MHRA) has granted a label extension to Clinigen’s melatonin 1mg/ml oral solution for the short-term treatment of jet lag in adults and sleep onset insomnia in children and adolescents between the ages of 6 and 17 with attention deficit hyperactivity disorder (ADHD).1

Results of a trial in 105 children aged 6 to 12 showed that melatonin increased sleep duration in children with ADHD and sleep onset insomnia.1.2 The results demonstrated that with the use of melatonin, children with ADHD and sleep onset insomnia can reduce sleep latency and increase sleep efficiency.

Children with sleep onset insomnia advanced on dimly lit melatonin by 26.9 (± 47.8) minutes, while placebo was delayed by 10.5 (± 37.4 minutes; P <.0001>1 The melatonin onset group had an advance of 44.4 (± 67.9) minutes while the placebo had a delay of 12.8 (± 60.0 minutes; P P = .01).

“We welcome the MHRA’s approval for a condition that negatively affects the quality of life of children and adolescents diagnosed with ADHD and increases the burden on support networks,” said Henno Welgemoed, director of medical affairs at Colonis in a statement.2

The randomized, double-blind, placebo-controlled study lasted 4 weeks. 1 Patients received either 3 or 6 mg of melatonin (depending on body weight) or placebo. The primary outcomes were sleep onset, total sleep time, and melatonin appearance in salivary dim light, which were derived from actigraphy. The results showed that the mean sleep diary item score for difficulty falling asleep decreased by 1.2 (± 1.3) points with melatonin and by 0.1 (± 0.8) points with placebo (P <.0001>1

Principal investigator Kristiaan van der Heijden, PhD, Associate Professor, University of Leiden, and colleagues noted, “Melatonin improved objective sleep onset and sleep duration, reduced subjective difficulty in falling asleep, and induced advances in falling asleep by more than 30 minutes in about half of the children treated with melatonin. Melatonin has not demonstrated an effect on cognitive performance, behavior and quality of life in children.1

“This approval provides a valuable treatment option for children and adolescents with ADHD and sleep onset insomnia, further expanding Colonis’ growing pediatric portfolio while supporting the Clinigen Group’s mission to deliver the right medicine to the right patient. at the right time,” Welgemoed said in a statement.2

Other results of the trial included the inter-daily stability of sleep-wake rhythm, which ranged between 0.65 and 0.64 and was similar to the 0.63 that was shown previously in children with ADHD who did not suffer from ADHD. ‘insomnia. Although it is slightly lower than that of children without ADHD or insomnia (unpublished results; 0.68 ± 0.13; n = 9;).1.5

One of the limitations of the study was a large amount of missing data for some of the behavioral and quality of life measures, as well as a low risk of reporter bias since the amount of missing data was the same for the two treatment groups. Another limitation was that the results may not be relevant for children with ADHD treated with stimulants, as the results suggest that impaired sleep may be the effect of treatment with stimulants.3.4

Van der Heijden et al noted, “We recommend that melatonin treatment be prescribed only when complaints of insomnia are persistent and severe and impose a burden on the individual child, if possible after improvement of possible extrinsic factors. and preferably in children with delayed onset of endogenous melatonin rhythm.

1. Van der Heijden KB, Smits MG, Van Someren EJ, Ridderinkhof KR, Gunning WB. Effect of melatonin on sleep, behavior and cognition in ADHD and chronic sleep onset insomnia. J Am Acad child psychiatry for adolescents. 2007;46(2):233-241. doi:10.1097/01.chi.0000246055.76167.0d
2. The MHRA approves a treatment that helps ADHD children and teens with sleep onset insomnia. PharmaWeb. October 4, 2022. Accessed October 20, 2022. – experience sleep onset insomnia
3. Ahmann PA, Waltonen SJ, Olson KA, Theye FW, Van Erem AJ, LaPlant RJ. Placebo-controlled evaluation of side effects of Ritalin. Pediatrics. 1993;91(6):1101-1106.
4.Stein MA. Unraveling sleep problems in treated and untreated children with ADHD. J Child Adolescent Psychopharmacol. 1999;9(3):157-168. doi:10.1089/cap.1999.9.157
5. Van der Heijden KB, Smits MG, Van Someren EJ, Gunning WB. Idiopathic chronic sleep-onset insomnia in attention deficit/hyperactivity disorder: a circadian rhythm sleep disorder. Chronobiol Int. 2005;22(3):559-570. doi:10.1081/CBI-200062410

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