NICE has published its assessment for the off-label and unlicensed use of the sleep drug melatonin in certain children.
The watchdog has specifically looked at melatonin to treat sleep disorders in children and young people with ADHD, and is the second topic of this type to be covered by NICE.
This is part of its new service to provide high quality information to the NHS and patients in England about the use of unlicensed and off-label medicines.
Produced by NICE’s Medicines and Prescribing Centre, the new report provides a summary of the published evidence for selected unlicensed or off-label medicines.
They provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies, but do not form official, legally binding NICE guidance.
Sleep disorders such as problems getting to sleep or staying asleep are more common in children with attention deficit hyperactivity disorder (ADHD).
Melatonin is a naturally occurring hormone produced by the brain and is involved in regulating a person’s body clock and helping to regulate sleep patterns. Although one melatonin product – Flynn Pharma’s Circadin – is licensed for use in treating sleep disorders in the UK, it is not licensed for use in people aged under 55 - its use in children and young people is therefore known as off-label.
It is available as a prescription-only prolonged-release preparation. Other melatonin products, often described as immediate-release capsules, tablets or liquids, are available from specialist suppliers and on the internet, but are not licensed for use in any patient group in the UK, and are therefore unlicensed.
NICE found that no studies assessed the use of off-label prolonged-release melatonin in children with both sleep disorders and ADHD. Limited evidence from two small studies suggested that taking unlicensed melatonin just before bedtime reduced the time it took the children to fall asleep by an average of around 20 minutes and improved the total time they were asleep by 15 to 20 minutes.
The studies did not, however, accurately assess the effectiveness of melatonin on sleep disorders past 30 days and so its effect in the medium and long-term is uncertain. Nor was any robust evidence of an improvement in the children’s behaviour after using melatonin identified.
But NICE said that parental satisfaction with melatonin was reported to be high, with nearly 90% of parents expressing the opinion that “melatonin is an effective therapy for the sleep onset problems of my child” and over 70% that “melatonin improved daytime behaviour of my child”.
Professor Mark Baker, director of the centre for clinical practice at NICE, said: “While a licensed medicine meets acceptable standards of efficacy, safety, and quality, clinical situations will arise where the use of unlicensed medicines or the use of medicines to treat conditions for which they are not licensed may be judged by the prescriber to be in the best interest of the patient. Up until now there has been a lack of nationally available, good quality information about using unlicensed and off-label medicines.
“This new resource from NICE, while not formal guidance, will help to ensure that the decisions of clinicians and the choices made by patients are properly informed and made on the basis of the best available evidence. It will also help avoid potential duplication of effort where, as happens currently, different NHS organisations undertake their own analyses of the evidence.”
Other topics that will form the first tranche of NICE evidence summaries for unlicensed or off-label medicines include:
• Tranexamic acid – severe bleeding (published October 2012)
• Diltiazem cream 2% - anal fissure
• Midodrine - postural hypotension
• Metformin tablets - Polycystic ovary disease
• Modafinil tablets - decreasing fatigue in MS
• Magnesium glycerophosphate oral – hypomagnesaemia
• Clonidine - ADHD as sole treatment and adjunct
• Rituximab in mantle cell lymphoma