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  • 1. GREATER MANCHESTER INTERFACE PRESCRIBING GROUP On behalf of the GREATER MANCHESTER MEDICINES MANAGEMENT GROUP SHARED CARE GUIDELINE for melatonin in the treatment of Reference Number sleep disorders in children and adolescents MELA09fnl Scope: Classification Pennine Care NHS Foundation Trust SHARED CARE GUIDELINE Bury PCT Oldham PCT Heywood, Middleton & Rochdale PCT Stockport PCT Tameside & Glossop PCT Issue date 13 July 2009 Replaces on this website December 2007 document (written by Central Manchester and Manchester Children’s University Hospitals NHS Trust) Author(s)/Originator(s) Pennine Care NHS Foundation Trust To be read in conjunction with the Melatonin patient information leaflet following documents Melatonin information for medical practitioners Review Date 3 July 2011 Approved by Interface Prescribing 12 October 2009 Committee 1. Introduction • Insomnia is a widespread problem in children with neurodevelopmental or psychiatric disorders such as autistic spectrum disorder & attention deficit hyperactivity disorder (ADHD). • Although non-behavioural treatments, such as behavioural therapy can be very effective in some forms of paediatric insomnia, children with neuropsychiatric disorders tend to have a lower response rate to behavioural therapy. • Currently there are no licensed treatments for sleep disorders in children in the UK. • Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced by the pineal gland during the dark hours of the day and night. It is used as a treatment of sleep disorders in children. • The use of melatonin is supported by NICE in their Clinical Guidelines on the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adults and children. The NICE guidelines G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 1
  • 2. states that melatonin may be considered for children and adolescents with CFS/ME who have sleep difficulties, but only under specialist supervision. 2. Scope • Pennine Care NHS Foundation Trust and associated PCTs. Acute Trust SLA partners 3. Clinical condition being treated • Insomnia is a common problem for children with sensory deficits and some learning disabilities. It can be a symptom of childhood psychiatric disorders such as depression and ADHD. Sleep disorders affect approximately 10% of otherwise normal children and up to 80% of children with developmental disorders. Indication for use: 1. Documented neurological or neuro-developmental disorder. 2. Documented severe, disrupted sleep disturbance. 3. Failure to respond to behavioural treatments. The patient will usually have been asked to keep a 24 hour sleep diary for a period of at least 7-10 days. • Melatonin is a naturally occurring hormone produced by the pineal gland in a circadian manner. The production of melatonin is suppressed by light and serum melatonin levels are very low during most of the day. Melatonin is involved in the induction of sleep and responds to darkness. The rise of melatonin precedes the onset of sleep by about 90 minutes. • Melatonin is thought to have its effect via GABA receptors. • Since there is a link with circadian rhythms and it being a 'natural' product, melatonin has been prescribed for the treatment of sleep disorders underpinned by learning disability, autistic spectrum disorders and ADHD. • Melatonin use should be monitored by specialist review every 6 months. • The patient and carer should attend specialist review meetings and be given information about sleep patterns, compliance, side effects, and response to treatment. • Treatment decisions should be shared between patient, carer and the Specialist. 4. Product information and treatment regimen to be used NB Following the UK launch of Circadin (melatonin 2mg prolonged release tablets), the Medicines and Healthcare products Regulatory Agency (MHRA) has issued drug procurement advice stating that unlicensed imports of melatonin will only be authorised in the case of a special need. The licensed product should be used wherever possible, including off-label use if deemed suitable by specialist. (a) Circadin is the only UK licensed product which contains melatonin. It is a 2mg prolonged release tablet. It is licensed for the short-term treatment of G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 2
  • 3. primary insomnia characterised by poor quality sleep patterns who are aged 55 or over. The MHRA would prefer an ‘off-label’ licensed product be used if it can meet the clinical need, than an unassessed, unlicensed product. (b) If Circadin can not meet the clinical need, an imported product should be used, which is licensed in the country of origin. This would be Bio-Melatonin which is manufactured in Hungary by Pharma- Nord and available as 3mg tablet (non-scored). It is manufactured in Good Manufacturing Practice (GMP) inspected facilities in Denmark. In order for the patient to receive supplies of this product the medical practitioner will need to provide written conformation of special clinical need; this means the medical practitioner must fill out a ‘Proforma letter of Special Clinical Need’. This letter must be taken with the actual prescription to a Community or Hospital Pharmacy for dispensing. The product will not be available straight away as the Pharmacist will need to fax the letter to Pharma Nord for a supply to be made to them and subsequently to the patient. (c) If a different strength of immediate release melatonin product is required then a product such as those manufactured by Penn Pharmaceutical Services may be used. These are unlicensed products, although Penn Pharmaceutical Services have a UK ‘specials’ license and their products are manufactured in GMP inspected facilities. A ‘Proforma letter of Special Clinical Need’ is not required to obtain a supply of this product. Dose For prolonged release melatonin (Circadin) • Initially 2mg once at night and increased if necessary • The dose should be taken 1-2 hours before bedtime and after food • The tablets should be swallowed whole. They should NOT be crushed or cut in half For immediate release melatonin • Initially 1-3mg at night, increasing after 1-2 weeks to 4-6mg (if response or partial response). • Maximum of 10mg/day (although 12mg has been used) • The dose should be taken about an hour before bedtime. • If the child wakes during the night, the same dose can be repeated during the night • Melatonin is available as a tablet, capsule, soluble tablet or liquid, depending where the medication is obtained from Product Selection Special clinical need would be the overall reason for not using a licensed product ‘off-label’. Effectiveness and side effect profile is similar, between immediate-release and modified-release formulations of Melatonin. Factors favouring use of single dose modified-release preparations would be G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 3
  • 4. licensing, issues around fluctuating control or compliance, individual tolerance, and patient/ carer preference. 5. Regimen Management a) Aspects of care for which the Specialist is responsible. The term Specialist includes Child and Adolescent Psychiatrist, Paediatrician, or nominated Advanced Practitioner/ Non Medical Prescriber (in agreement with their medical supervisor) • Direct assessment or supervision of specialist team assessment, evaluation of prior treatment, and rationalisation of treatment with melatonin. • Informing patient/ carer of diagnosis, care plan, treatment including side effects and ‘off-label’ use of melatonin, or use or unlicensed product. Use of Patient Information Leaflets (PILs), user-friendly information leaflets for children/ adolescents. • Ascertaining patient/ family’s commitment to safe storage and handling of medication. • Initiation and titration of melatonin to a suitable dose. • Promoting access to any appropriate supporting therapies, carer education, and appropriate school liaison. • Minimum 6 monthly Specialist review appointments. • Asking General Practitioners (GP) if they are willing to participate in shared care. • Written correspondence to GP from Specialist Team, summarising progress and recommendations for continued treatment. • Ensure clear arrangements for GP back up, advice and support. • Reporting suspected adverse drug reactions to the MHRA. • Discontinuation of treatment, (or transfer if appropriate). b) Conditions of assuming responsibility by the GP • Satisfactory initiation, titration to optimum dosage, and response to treatment by Consultant/ Specialist Team G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 4
  • 5. • Communication of satisfactory baseline physical checks from Consultant/ Specialist Team to GP • Follow up at 6 monthly intervals and monitoring of progress and response to medication by the Consultant/ Specialist Team. Where the Consultant/ Specialist Team amend the dose the GP will be informed c) Aspects of care for which the GP is responsible • Replying to request for shared care as soon as possible. • Continued prescribing of melatonin in the community under guidance of Consultant/ Specialist Team at the dose requested. • Referring back to the Consultant/ Specialist Team for queries regarding treatment / side effects, and concerns about compliance or suspected drug misuse. • Stopping treatment on the advice of the Consultant/ Specialist Team. • Continuation without Specialist review is not recommended. • Reporting noted adverse events to the Consultant/ Specialist Team and CSM. 6. Summary of cautions, contra indications, side-effects Cautions • Patients with epilepsy (see under side effects). • Lactose intolerance. • May exacerbate asthma in short term. Contraindications • Pregnancy or breastfeeding. • Patients taking monoamine oxidase inhibitors. • Patients with severe allergies, autoimmune diseases or immune system cancers, or taking immunosuppressants. Melatonin has been shown to have an effect on the immune system and both enhanced immune response and immunosuppression have been noted. Side effects • Melatonin is generally well tolerated but long term side effects have not been evaluated. • Mild headaches are the most common side effect. • Other CNS effects reported include: dizziness, increased irritability, altered sleep patterns, restlessness and confusion. G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 5
  • 6. • Increased seizure activity has been reported in patients with epilepsy but there is also anecdotal evidence that seizure activity improves as a result of improved sleep. • Nausea, tachycardia and pruritis have been reported rarely. Interactions • Anticoaglants • Antiplatelet drugs • Antidiabetic agents • Benzodiazepines • CNS depressants • Contraceptives • Flumazenil • Fluvoxamine • Immunosupressants • Nifedipine • Verapamil Please also check the latest list of interactions contained within the current edition of the British National Formulary (BNF) 7. Special considerations • Handover for shared care largely by written agreement. Individual consideration of patients to occur when issues of tolerance, inconsistent response to treatment, pre-existing medical conditions or issues of patient compliance. • Obtaining melatonin may take up to 14 days. Therefore patients/carers should request repeat prescription from their GP in advance 8. Back-up care available to GP from Hospital, including emergency contact procedures and help line numbers • Written correspondence following Consultant/ Specialist Team appointments, specifically detailing the next review date and any dose adjustments. • Telephone advice/ information from the Consultant / Specialist Team during office hours, and plans for earlier review by team if necessary. • Out of hours on call/ emergency service contactable through hospital switchboards. 9. Statement of agreement G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 6
  • 7. • Shared care is an agreement between the GP and the Consultant. This Shared Care Guideline is a request by the consultant to share the suggested care pathway of your patient. • If you are unable to agree to the sharing of care and initiating the suggested medication, please make this known to the consultant within 14 days, ideally stating the nature of your concern. 10. Written information provided to the patient • Melatonin patient information leaflet • Unlicensed medication information leaflet • ‘Proforma letter of Special Clinical Need’, if appropriate 11. Supporting References • The Maudsley: Prescribing guidelines (9th Edition) 2007. Informa healthcare. • Medicines For Children 2003. Royal College of Paediatrics and Child Health. • BNF for Children 2008. • Summary of Product Characteristics. www.medicines.org.uk • Drug procurement advice: Restrictions on the import of unlicensed Melatonin products following the grant of a marketing authorisation for Circadin® 2mg tablets. MHRA. August 2008 • UKMI- London New Drugs Group. APC/DTC Briefing. September 2008 G/TGH/HQSecs/TD/LS/SCG/Melatonin SCG Version 1.July 2009 GMMMG amendment 7