FIRST LICENSED MELATONIN FOR SLEEP DISORDERS IN CHILDREN AND ADOLESCENTS WITH ADHD LAUNCHES IN UK

• Melatonin is commonly used to treat insomnia, but until now prescribing for children with ADHD has been off-label or unlicensed
• Many GPs (50%) are reticent to take on prescribing of off-label/unlicensed medicines^[i] putting pressure on overstretched specialists, where unsuccessful GP referrals have increased by 87% in recent years^[ii]
• It is estimated the newly launched drug, Adaflex, could save the NHS almost £11 million in melatonin prescriptions^[iii]

London, UK & Lund, Sweden, July 2022 – Swedish Pharmaceutical Company, AGB-Pharma, has recently launched Adaflex, the UK’s first melatonin product for insomnia in children and adolescents aged 6-17 years old with ADHD (where sleep hygiene measures have been insufficient). Melatonin has long been understood as an effective and safe treatment for supporting circadian rhythms and managing sleep related problems^[iv]. It is one of the most commonly used drugs for paediatric sleep problems, in particular those with neurodevelopmental related sleep disorders^[v].

Sleep disorders are common in children with ADHD; up to 73% will experience sleep problems^[vi]. Researchers have suggested that young children need 9-10 hours’ sleep (less for older teenagers) on a regular basis to maintain optimal health^[vii] but sleep problems associated with ADHD can make this difficult to achieve. Lack of sleep can worsen ADHD symptoms, have a negative impact on children’s emotions and behaviour, disrupt school performance, peer relations and family functioning⁷. In a recent survey of child psychiatrists the effects of sleep deprivation were described as “explosive”, some even said it “breaks families”¹.

Melatonin has been shown to influence circadian rhythmicity^[viii] helping to improve sleep wake rhythm disturbances and decrease sleep latency in children^[ix]. Recent NICE data has found that 87.8% of parents who treat their child with melatonin consider it an effective therapy, particularly for sleep onset^[x]. However, until now there had been no melatonin treatment licensed for children with ADHD in the UK, which according to AGB’s data, means roughly 60% of all melatonin prescriptions are dispensed to under 18’s off-label or unlicensed^[xi].

Specialists who prescribe melatonin may struggle to implement a shared care agreement with the patients’ GP. In fact, recent research suggests that around 50% of GPs feel reticent to prescribe off label/unlicensed melatonin products¹. This means that ongoing prescription responsibilities remain with overstretched specialists. Exacerbated by the COVID-19 pandemic, NHS waiting lists have grown significantly. GP referrals into specialist services such as psychiatrists which have been unsuccessful due to capacity issues has also increased - from 238,859 in February 2020 to 401,115 in November 2021 - an 87% increase². Furthermore, Children and Adolescent Mental Health Services (CAMHS) saw 420,000 patients in 2020-2021, but a fifth had to wait over 12 weeks to be seen. The average wait was more than two months^[xii].

Consultant Child and Paediatric Psychiatrist, Dr María Martínez Hervés, comments: “Sleep is imperative for normal day-to-day functioning. However, sufficient good quality sleep can be a struggle for children with ADHD, affecting everything from cognitive function and learning, to family life and social behaviour. It is well established that melatonin is a safe and effective treatment for sleep disorders in children and adolescents with ADHD. Having a licensed melatonin product could ease the transition of patients from a specialist service to general practice.”

Furthermore, patients’ parents/carers have to liaise with specialists to obtain repeat prescriptions. This could involve long drives to clinics based in hospitals or standalone clinics to pick up a prescription which could potentially be easily filled out at the local pharmacy.

AGB-Pharma CEO Fredrik Lindberg added that: “It is hoped that now a licensed medication for children and adolescents is available, shared care agreements between primary and secondary care will be possible in more cases, streamlining the patient care pathway”.

As well as significant potential benefits for both healthcare professionals and parents/carers, Adaflex could lead to substantial financial benefits for the NHS and other healthcare providers. According to AGB-Pharma research, calculated using NHS prescription data, if all melatonin prescriptions were switched to Adaflex, the NHS would save just under £11m per year³.

Unlike other melatonin products, Adaflex is available in a range of doses (1mg, 2mg, 3mg, 4mg and 5mg) allowing flexible titration. Previously, tablets may have had to be split/halved to make up intermediate doses, an added nuisance to parents and carers. The recommended starting dose of Adaflex tablet is 1-2mg 30-60 minutes before bedtime and the lowest possible dose should always be sought. If the patient’s doctor sees adequate improvements in a patients sleep they will inform the patient they should remain on the current dose. If sleep symptoms persist, doctors can increment the dose by 1mg until a successful dose regimen has been established.

NHS decision makers and payers have already begun adding Adaflex to a number of formularies across the UK, with many more to be added in the coming weeks (having already been successfully launched in Sweden by pharmaceutical company AGB-Pharma).

To request a call from an Adaflex representative, please email: info@agb-pharma.com  

[i] AGB-Pharma (2021) SLEEP DISORDERS IN CHILDREN WITH ADHD A Qualitative Interview Study with Child Psychiatrists in the UK – Data on file

[ii] NHS Backlog Data Analysis, Available at: https://www.bma.org.uk/advice-and-support/nhs-delivery-and-workforce/pressures/nhs-backlog-data-analysis#:~:text=October%202019%20to%20December%202021&text=The%20number%20of%20GP%20referrals,(an%2087%25%20increase) accessed May 2022

[iii] AGB Budget Impact Assessment Model, IMS Prescription Data March 2022 - Data on File

[iv] Medical Products Agency – Sweden (2019) Public Assessment Report – Melatonin AGB, www.mpa.se

[v] Hartz I, Furu K, Bratlid T, Handal M, Skurtveit S. Hypnotic drug use among 0–17 year olds during 2004–2011: a nationwide prescription database study. Scand J Public Health. 2012;40(8):704–711.

[vi] Wajszilber D et al 2018, Sleep Disorders in patients with ADHD: impact and management, Nature and science of sleep 2018:10 453 - 480

[vii] Sundell AL, Angelhoff C. Sleep and its relation to health-related quality of life in 3-10-year-old children. BMC Public Health. 2021 Jun 2;21(1):1043. doi: 10.1186/s12889-021-11038-7. PMID: 34078330; PMCID: PMC8173783.

[viii] Van Geijlswijk IM, Korzilius HP, Smits MG. The use of exogenous melatonin in delayed sleep phase disorder: a meta-analysis. Sleep. 2010; 33(12):1605–1614.

[ix] Appleton RE, Gringras P. Melatonin: helping to mend impaired sleep. Arch Dis Child. 2013;98(3):216–217.

[x] ADHD: Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin. NICE Evidence Summary ESUOM2. Published 4th Jan 2013

[xi] Medical Data Index Data from IMS for FY 2020 – Data on File

[xii] BBC freedom of information request: Long waits for specialist child mental health care in England, Available at: https://www.bbc.co.uk/news/health-58565067 accessed May 2022