MELATONIN FOR SLEEP DISORDERS IN CHILDREN AND ADOLESCENTS WITH NEURODEVELOPMENTAL DISORDERS SHARED CARE GUIDELINES

Transcription

1 MELATONIN FOR SLEEP DISORDERS IN CHILDREN AND ADOLESCENTS WITH NEURODEVELOPMENTAL DISORDERS SHARED CARE GUIDELINES Version control: Version Date Main changes/comments V1 4 June 2013 First draft circulated for comments to community paediatricians and GPs. V2 10 June 2013 Incorporated comments from GPs. V3 9 September 2013 Incorporated comments from community paediatricians, choice of preferred products finalised. V4 24 September 2013 Incorporated additional comments from medicines management and community paediatricians. V4 1 October 2013 Ratified by Medway Clinical Commissioning Group (CCG) Clinical Advisory Group. V4 9 October 2013 Approved by Medway CCG Commissioning Committee. V4 13 th November 2013 Approved by Medway Drugs and Therapeutics Committee. V4 15 th November 2013 Approved by Swale CCG Clinical Strategy Committee. Review date: November

2 Melatonin is an endogenous hormone used in the treatment of persistent sleep onset disorders in children and adolescents (4 17 years inclusive) with a range of neurodevelopmental problems, including Attention Deficit Hyperactivity Disorder (ADHD). Melatonin (2mg to 12mg) is only indicated second line, where non pharmacological strategies have been tried, but sleep latency remains a significant problem. Melatonin is not recommended for the treatment of night time waking. Melatonin MR tablets (Circadin ) is the first line melatonin product to prescribe in NHS Medway CCG, NHS Swale CCG and NHS Medway Foundation Trust. The aim of this shared care guideline is to ensure that clinicians have the necessary information available to allow them prescribe melatonin where it would be appropriate to do so and to ensure all parties are clear about their responsibilities. The guidelines should be used in conjunction with other relevant information and recommendations provided by the consultant. The clinician who prescribes the medication legally assumes clinical responsibility for the drug and the consequence of its use. If the prescriber feels they cannot prescribe melatonin, the specialist should be informed as soon as possible to enable appropriate arrangements to be made with the family. IMPORTANT NOTES Parents, carers or older adolescents (if appropriate), are required to complete a sleep diary for at least ten nights showing significant problems with sleep latency before treatment with melatonin is initiated. This is to be maintained after treatment has been started to establish efficacy. An example of a sleep diary is available in Appendix 1. Upon initiation, if improvement in symptoms is not observed after one month, melatonin should be discontinued. If melatonin has successfully established a good sleep pattern, a trial withdrawal of melatonin should be undertaken at the first, subsequent specialist review which will occur 3 to 6 months following initiation. The continuing need for melatonin should be assessed periodically by the specialist including by stopping the medicine for up to two weeks each year. Melatonin will usually be discontinued by late adolescence (by 18 years) on the recommendation of the specialist. Caution is advised in children and adolescents with autoimmune, renal or hepatic disorders due to limited safety data. 2

3 AREAS OF RESPONSIBILITY Secondary care specialist responsibilities. 1. Ascertain the need for sleep onset treatment in neurodevelopmental disorders. 2. Ensure all relevant investigations are performed. 3. Prescribe melatonin as a second line treatment option where non pharmacological strategies such as provision of sleep hygiene advice (over 3 6 months) have failed, and underlying physical causes are managed. To prescribe melatonin where parent or carer or an older adolescent has completed a sleep diary over 10 to 14 nights highlighting problems with sleep latency despite a trial of non pharmacological strategies. 4. After an informed discussion, obtain formal, written consent from the parents or carers regarding treatment with melatonin. 5. Following informed consent, provide a 4 week supply of melatonin at an appropriate dose and in an appropriate formulation. 6. Contact the patient s GP to request prescribing under shared care and send a link to or copy of the shared care protocol. 7. Provide the GP with an initiation letter ideally within 14 days of seeing the patient (which includes diagnosis, relevant clinical information, baseline results, treatment to date and dose of melatonin that the patient is stabilised on, treatment plan, duration of treatment before consultant review). 8. Upon initiation or dose changes, provide parents, carers or patients (if appropriate) with information about melatonin (including potential adverse effects and action to take) in an appropriate format, usually in the form of a written leaflet. Please refer to the link for aleaflet/melatonin for sleep disorders/ for a leaflet entitled Melatonin for sleep disorders. Advise and support parents, carers, patients (if appropriate) or older adolescents. 9. Advise the patient of the need to make an appointment with their GP within two weeks of receiving initial supply of melatonin from the specialist for review and assessment of suitability for ongoing melatonin prescriptions. 10. Review patients 3 6 months after initiation of melatonin and 6 12 months thereafter in order to assess the benefits of continued treatment. A trial withdrawal should be considered at each medication review. Results of any review must be communicated promptly to the GP. 11. Take back care of the patient should the GP feel unable to continue to manage the prescribing of melatonin. 12. Provide advice to the GP if they have clinical queries relating to the condition or use of melatonin. 13. Notify the GP of the patient s failure to attend appointments and give advice on stopping the medication. 14. Take responsibility for stopping melatonin or to agree aftercare when the patient reaches 18 years of age. GP responsibilities 1. Initial referral to secondary care in line with the referral criteria. 2. Inform the specialist, within three weeks of receiving the request to share care, if unwilling to enter into shared care arrangements. 3. Assess the effectiveness of the initial 4 weeks supply of melatonin before providing further repeat prescriptions. (It is recommended that no more than one month s prescription should be issued at a time). Inform specialist if melatonin is discontinued. Template questions for review are available in Appendix Two. 4. Contact the specialist if there are ongoing sleep problems. 5. Manage adverse reactions or report to the specialist. 6. Act upon recommendations communicated by the specialist, including recommendations on stopping melatonin. 7. Monitor the prescribing rate of melatonin for individual patients and report concerns to the specialist. 8. Review the appropriateness of prescribing for patients who have not been seen by a specialist for over one year. 9. Ensure all relevant staff within the practice are aware of the shared care guidelines. 3

4 Patient / Parent / Carer Responsibilities 1. Attend appointments. 2. Complete a sleep diary before initiation, and during treatment to help evaluate efficacy. 3. Make an appointment with the GP within two weeks of receiving initial supply of melatonin from the specialist for review and assessment of suitability for ongoing melatonin prescriptions. 4. After an informed discussion, give formal, written consent regarding treatment with melatonin. 5. Adhere to instructions on the use of melatonin. 6. Inform the GP if health problems arise. To be aware of side effects and report any relevant symptoms to the GP. Any serious reaction should be reported to the Commission of Human Medicines (CHM) by whoever they are highlighted to. Use the Yellow Card System to report adverse drug reactions. Yellow Cards and guidance on its use are available at the back of the British National Formulary or online at PRODUCTS TO PRESCRIBE First line Second line Third line Prescribe only if there is a justified, clinical reason why the patient cannot tolerate tablets swallowed whole or crushed. Name of product Route of administration Recommended starting dose Melatonin 2mg Modified Release tablets (Circadin ) Oral may be crushed.* 2mg once daily, 1 2 hours before bedtime and after food. If crushed, take half hour before bedtime #. Melatonin 3mg tablets (Bio Melatonin ) Oral can be crushed. Can be administered via PEG tube. Initially 3mg once daily taken half hour before bedtime #. Melatonin 2mg or 3mg capsules Oral capsules can be opened up. Initially 2 3 mg once daily. Melatonin 5mg/5ml solution Melatonin 5mg/5ml suspension Oral liquid. Initially 2 3mg once daily. Titration of dose Increase by 2mg depending on response every 7 14 days. Increase to 6mg depending on response after 7 14 days. Increase to 6mg depending on response after 7 14 days. Increase by 2 3mg depending on response after 7 14 days. Maximum dose 8mg 12mg daily but additional benefits from doses above 6 9mg are uncertain. Adjunctive Sleep hygiene (advice) Sleep hygiene (advice) Sleep hygiene (advice) Sleep hygiene (advice) treatment regimen License status Licensed in UK (off label Unlicensed in UK. Licensed Unlicensed. Unlicensed. use in children). in EU. * When crushed, the modified characteristics of Circadin are lost and it acts an immediate release preparation. # Also consider anticipated sleep time. 4

5 Switching recommendations It is recommended that an audit of current patients prescribed Melatonin is carried out to ensure treatment is clinically and cost effective and in line with these guidelines. Where clinically appropriate, existing patients prescribed alternative, unlicensed products should be switched to the nearest whole tablet of Circadin. For example: Patients currently prescribed a dose of unlicensed Melatonin 2mg preparations equivalent to a dose of Circadin may be switched to the same dose e.g. 2mg of unlicensed melatonin to 1 x 2mg Circadin; 6mg of unlicensed melatonin to 3 x 2mg Circadin. Patients not currently prescribed an equivalent dose, may be switched to the nearest dose e.g. 3mg unlicensed Melatonin to Circadin 1 x 2mg m/r tablets (2mg dose). PRESCRIBING INFORMATION. See Summary of Product Characteristics or product information sheet for further information. Baseline Data and Routine Monitoring Monitoring of height and weight is recommended. Adverse effects Melatonin is generally well tolerated. Sedation and fatigue, headaches, skin disorders, restlessness, increased pulse, itching and nausea have all been reported as side effects associated with melatonin use. Cautions Melatonin should be used with caution in patients with a history of epilepsy, asthma, autoimmune, renal or hepatic disorders. Contra indications Pregnancy and breast feeding. Known hypersensitivity to melatonin or to any of its excipients. Drug interactions It is advisable not to prescribe melatonin if the patient is receiving antipsychotics or antidepressants. Concomitant prescribing of melatonin and oral anticoagulants should be avoided. REFERENCES 1. Appleton RE, Gringras P (2013). Melatonin: helping to MEND impaired sleep. Arch Dis Child 2013; 98: Appleton RE, Jones AP et al (2012). The use of Melatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomized, double blind, placebo controlled, parallel study (MENDS). Health Technology Assessment 2012; vol 16: no Bunn R (2013). Melatonin and its use in children. The Pharmaceutical Journal 2013; 290 (9 Feb) page Flynn Pharma Medical (2012). Evidence based review of melatonin for sleep disorders in children with neurodevelopmental disorders. 5. Kent, Surrey & Sussex Health Policy Support Unit (2013). Policy Recommendation PR : Melatonin for sleep disorders in children and adolescents with neurodevelopmental disorders. Available via recommendations/ 6. Medicines for Children. Melatonin for sleep disorders Patient Information Leaflet. Available via for a leaflet/melatonin for sleep disorders 7. NICE (2013). ESUOM2 Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin. Available via 5

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7 APPENDIX 1a Sleep diary Sleep Diary DATE:... Medication used for sleep (if any) and dosage:.. NAME:... Time woke/woken in the morning? Time got up What did he/she do between waking and getting up? Time and length of all daytime naps? What did he/she do in the hour before bedtime? What time did he/she go to bed? What time did he/she fall asleep? What happened in between got to bed and falling asleep? Time and length of all wakes during the night. Please describe what happened. Anything else of importance? 7

8 Appendix 1b Example of a completed sleep diary Example of a Sleep Diary DATE: 12/07/13 NAME: John Smith Time woke/woken in the morning? Time got up What did he/she do between waking and getting up? Time and length of all daytime naps? What did he/she do in the hour before bedtime? What time did he/she go to bed? What time did he/she fall asleep? What happened in between going to bed and falling asleep? Time and length of all wakes during the night. Please describe what happened. 7.30am woken by mum 7.50am got up by mum Lay in bed looking at book until mum made him get up to have breakfast Had a nap at 4.30 when he got home from school for about 60 minutes. Had tea watched TV played computer games had a bath came back down stairs for cuddles and drink. Told him it was time for bed and he started to scream and hit out. Did not appear to be tired. Carried upstairs and put him in his room. 7.30pm 11.45pm Kept getting out of bed and coming downstairs, lots of shouting and screaming. Mum kept returning him to bed. Kept getting out of bed. In the end mum laid down with him in the bed until he fell asleep. Woke during the night at 2am for 30minutes and 3.30am for 20minutes. He came into mum and dad s room and tried to get into our bed. Mum took him back to his room. Each time he insisted that mum lay with him which I did until he fell asleep and then I went back to bed. Anything else of importance? He is very restless at night and snores very loudly. 8

9 Appendix 2 Review questionnaire Patient Name:... Review Questionnaire for the effective use of Melatonin. Date of Birth:... NHS No:... Date of medication review: Date of next medication review: What Melatonin dose is your child taking? Is your child taking any other medication to aid sleep? How long has your child been taking Melatonin? What time is Melatonin given? What time does your child fall asleep? Where does your child fall asleep? Does your child remain asleep for the rest of the night? Outcome of Review: a) Continue the use of Melatonin Yes / No Rationale: b) Discontinue the use of Melatonin Yes / No Rationale: c) Trial cessation of Melatonin in conjunction with 2 weeks sleep diaries Yes / No Rationale: :.. 9