MELATONIN Insomnia and Sleep Disorders in Children

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1 DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AS AND FILED IN NOTES Patient Name : Date of Birth: NHS No: Name of Referring Consultant: Contact number: INTRODUCTION Melatonin is a pineal hormone which affects sleep. It is normally secreted at night and its main function is the regulation of circadian rhythm and sleep, playing an important role in setting the correct timing of sleep - wake cycles. The administration of exogenous melatonin has a rapid, transient, mild sleep inducing effect and it lowers alertness, body temperature and performance for about 3 to 4 hours after the administration of low doses of immediate release formulations. Clinical experience suggests that it may be of value for treating sleep onset insomnia and delayed sleep phase syndrome in children with conditions such as visual impairment, cerebral palsy, attention deficit hyperactivity disorder, autism, and learning difficulties. Melatonin use in children is off-license but this use is supported in the BNFc see USUAL CARE PATHWAY AND RESPONSIBILITY ARRANGEMENTS ACROSS PRIMARY AND SECONDARY CARE Speciality Indication Duration Prescribed by Monitored by For recommendation by a specialist and continuation by General Practitioner (GP) Paediatric Insomnia in neurologist and the above CAMHS (ELFT) group To be reviewed 6 monthly by the hospital paediatric neurologist /CAMHS team. Can be initiated by GP on recommendation of paediatric neurologist/camhs. If clinically urgent, specialist to initiate. Hospital Paediatric team/camhs/gp Patient recommendation/transfer will be done via a letter from the Paediatric Consultant/CAMHS consultant to the GP. It is unusual for a child to continue melatonin into adulthood. Should this be considered appropriate for a specific case, the specialist will advise the GP on future management. DOSE AND ADMINISTRATION Oral: 1 month 18 years: initially 2-3 mg (1-2 hours before bedtime and after food) increased if necessary after 1-2 weeks to 4-6 mg; max 10 mg Trial of up to 2 weeks off melatonin every six months is recommended. Please specify the brand of melatonin to be prescribed. This should be advised by the hospital. 1

2 COST MELATONIN Melatonin Circadin tablets m/r 2 mg Melatonin generic capsules 3 mg Circadin tablets should be used first line if the patient can obtain the appropriate dose and swallow tablets whole. Circadin is the only licensed melatonin product available and the recommendation in the BNFc is off label/license in children. The other products listed are all unlicensed medicines (specials) and the cost in primary care is variable and significantly higher than stated in this document. Circadin tablet can be halved using a tablet cutter and it will retain its slow release characteristics. For children with difficulties swallowing, the tablet can be crushed to a fine powder and mixed with water or given with cold soft food such as a teaspoon of yoghurt or jam. Use a small amount of food to ensure the full dose is taken. The prescription should state that the medication is to be crushed prior to administration. For administration via an enteral feeding tube, the tablet can be crushed to a fine powder and added to 15-30ml of water and mixed well. This should be drawn into a 50ml oral syringe and administered taking care to rinse the mortar/tablet crusher with water and administer the rinsing. The feeding tube should be flushed with 30ml water prior to and post drug administration. NOTE: crushing the MR tablet will mean that it is no longer modified release. Drug tariff generic liquid preparations are available and Special order liquid medicines or capsules (all unlicensed brands) are unlicensed and expensive and should ONLY be used where absolutely necessary. Refer to current BNFc and Summary of Product Characteristics for further information. ADVERSE EFFECTS Melatonin is generally well tolerated and adverse reactions reported are at similar levels to those reported with placebo. Tiredness, headaches, dizziness, pharyngitis, abdominal back pain, constipation, dry mouth, weight gain, asthenia and irritability, sleep disorders, restlessness, nervousness and sweating have been reported following its use. Other rare side effects include restlessness, confusion, increased heart rate, itching and nausea. High doses can reduce body temperature. Discontinuation does not appear to be associated with withdrawal effects. If any persistent and problematic side effects occur discontinue melatonin and refer the patient back to the hospital team CAUTIONS Cautions Drowsiness - driving or other activities that put the patient or others at risk should be 2

3 MELATONIN avoided if the patient is affected by drowsiness Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose- galactose malabsorption should not take Circadin brand melatonin (contains lactose) Patients with renal impairment Melatonin may worsen restless legs syndrome Melatonin can affect serotonin levels and should be used with caution in conjunction with other serotonin related agents. Pregnancy and Breast Feeding There are no known concerns with melatonin and pregnancy. Where young girls or women taking melatonin become pregnant, cases should be managed on an individual basis, seeking expert advice from the specialists. Use in pregnant women and by women intended to become pregnant is not recommended. Breast-feeding is not recommended in women under treatment with melatonin. CONTRAINDICATIONS Contraindications Hypersensitivity to melatonin or any excipients Patients with hepatic impairment Patients with autoimmune diseases or taking immunosuppressants Drug interactions 5 and 8-methoxypsoralen Use with caution with melatonin, increased melatonin plasma Alcohol Avoid reduces effectiveness of melatonin Carbamazepine and May give rise to reduced plasma s of melatonin. rifampicin Cigarette smoking May reduce melatonin s Cimetidine Use with caution with melatonin, increased melatonin plasma Ciprofloxacin and other Use with caution with melatonin, increased melatonin plasma quinolones Fluvoxamine Avoid use with melatonin as melatonin plasma s are markedly increased (metabolism inhibited) Nifedipine May affect blood pressure control Oestrogens Use with caution with melatonin, increased melatonin plasma Other hypnotics and CNS Melatonin may enhance the sedative properties of other drugs depressants acting on the CNS e.g. benzodiazepines Warfarin INR may be increased 3

4 MONITORING STANDARDS FOR MELATONIN No baseline monitoring is required. Treatment with melatonin should be recommended by a specialist and is usually monitored by the specialist every 6 months. If used long-term, the need for continuing therapy should be reviewed regularly by the specialist team. Treatment should be stopped in patients who do not continue to benefit from its use. Monitoring, particularly with regard to growth and pubertal/sexual development, is advised in children during long term administration, especially in those receiving melatonin for periods of a year or more and this will be carried out as part of the routine hospital reviews. ACTION AND ADVICE If adverse effects are not tolerated, melatonin can be stopped immediately. The patient s further therapy should be discussed with the patient s specialist. SHARED CARE Shared care guideline: is a document which provides information allowing patients to be managed safely by primary care, secondary care and across the interface. It assumes a partnership and an agreement between a hospital specialist, GP and the patient and also sets out responsibilities for each party. The intention to shared care should be explained to the patient and accepted by them. Patients are under regular follow-up and this provides an opportunity to discuss drug therapy. Intrinsic in the shared care agreement is that the prescribing doctor should be appropriately supported by a system of communication and cooperation in the management of patients. The doctor who prescribes the medicine has the clinical responsibility for the drug and the consequence of its use. Consultant 1. Recommend treatment and prescribe the first month if clinically urgent. 2. Ensure that patient/carers understand their treatment regimen and any monitoring or follow up that is required (using advocacy if appropriate). 3. Send a letter to the GP and reference guidelines for this patient and ensure the patient/carer understands they will need to make an appointment to receive a prescription/further prescriptions. 4. Clinical supervision of the patient by routine clinic follow-up on a regular basis. 5. Send a letter to the GP after each clinic attendance ensuring current dose is stated. 6. Evaluate any reported adverse effects by GP or patient. 7. Advise GP on review, duration or discontinuation of treatment where necessary. 8. Inform GP of patients who do not attend clinic appointments. 9. Inform GP, by letter, of clinic visits and action taken for management of patient. 10. Ensure that backup advice is available for patient and GP at all times. 11. Advise the GP of which specialist will provide future monitoring of the patient, should they need to continue melatonin once they reach adulthood. General Practitioner 1. Ensure that the patient/carer understands the nature, effect and potential side effects of the drug before prescribing it as part of the shared care programme and contact the specialist for clarification where appropriate. 2. Prescribe the drug as described 3. Monitor patient s overall health and well-being. 4. Report any adverse events to the consultant, where appropriate. 5. Report any adverse events to the CSM, where appropriate. 4

5 6. Help in monitoring the progression of disease. CCG 1. To provide feedback to trusts via Trust Medicines Committee. 2. To support GPs to make the decision whether or not to accept clinical responsibility for prescribing. 3. To support trusts in resolving issues that may arise as a result of shared care. Patient/Carer 1. Report any adverse effects to their GP and/or specialist whilst taking MELATONIN. 2. Ensure they have a clear understanding of their treatment. 3. Report any changes in disease symptoms to GP and/or specialist whilst taking MELATONIN. 4. Alert GP and/or specialist of any changes of circumstance which could affect management of disease e.g. plans for pregnancy whilst taking MELATONIN. 5. Takes medicines as directed. Use in adults A modified release formulation of melatonin is now licensed and marketed for the short-term treatment of primary insomnia, characterised by poor quality sleep, in patients aged 55 years or over. Its use in this indication is limited to a dose of 2mg at night for no longer than 3 weeks at a time. The use in adults is outside the scope of this guideline and not generally used at the hospital. CONTACT NUMBERS FOR ADVICE AND SUPPORT Barts Health NHS Trust Consultant via switchboard: Registrar on-call out of hours: Specialist Pharmacist Medicines Information (for drug information related queries) East London Foundation Trust Victoria Wood, CAMHS Pharmacist Lynda Iyeke, Lead Pharmacist Tower Hamlets see top of the document Air call via switchboard Andrea Okoloekwe, Lead Pharmacist - Newham ext 2065 Jennifer Melville, Lead Pharmacist City and Hackney Clinical Commissioning Groups Tower Hamlets, Newham and City & Hackney A patient information leaflet suitable for children s parents and carers is available at 5