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Melatonin Shared Care Guideline for the prescribing of Melatonin for sleep disorders in children and adolescents


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Shared Care Protocol –remains open to review in light of any new evidence

Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care.


Melatonin

Shared Care Guideline for the prescribing of Melatonin for sleep disorders in children and adolescents

Development Process


This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER classification status of Melatonin by the Barnsley Area Prescribing Committee. This guideline has been subject to consultation and endorsement by:

  • The Area Prescribing Committee on 10 December 2014

  • The LMC on 10th March 2015


Introduction


  • Melatonin and melatonin CR are used to improve the onset and duration of sleep in infants, children and adolescents with neurological and/or behavioural problems who have severe sleep disturbance. It can also be used to improve onset and duration of sleep in children and adolescents with congenital or acquired neurological/neurodevelopmental problems including conditions such as learning difficulties, Autism Spectrum Disorders, Cerebral Palsy, visual impairment, epilepsy and neurodegenerative disorders. It is also known that some psychiatric disorders can be associated with sleep problems e.g. ADHD or depression.




  • The treatment of choice for sleep disturbance is behavioural; melatonin should only be prescribed after a full trial of behavioural management has been tried and failed to achieve satisfactory results. Prescribers should confirm this has been conducted.


Dosage and administration

  • The usual starting dose is 2mg, increasing to 10mg maximum in 2mg steps. Patients are usually advised to take 30 to 60 minutes before bedtime.

In the UK a licensed modified release melatonin 2mg tablet (Circadin®) is available. This is only licensed for the short term treatment of insomnia in adults aged 55 years and over. Unlicensed immediate release preparations may be more suitable for children: the manufacturer should be specified because of variability in clinical effect of unlicensed products (see product information section).




  • Products and strengths available

The manufacturer should be specified on the prescription due to the variability in the clinical effect of unlicensed formulations. Recommended manufacturers are PharmaNord, Penn Pharmaceuticals and Special Products limited.


Standard release products (all unlicensed)

For patients with swallowing difficulties the capsules may be opened and mixed with cold milk, yogurt or fruit juice. This is much more cost effective than the use of the oral solution.

Capsules 1mg, 2mg, 2.5mg, 3mg, 5mg, 10mg

Orodispersible tablets 2mg, 3mg (these are flavoured)

Oral solution 1mg/ml (these are flavoured)

Tablets 3mg (pharma nord brand is most cost effective of current unlicensed preparations)


Modified release products

Melatonin 2mg prolonged release tablet, Circadin® (licensed and so first line choice for modified release). NOTE: Circadin tablets must be swallowed whole. The modified release property is lost if halved or crushed.

Life Extension® 3mg controlled release capsule (unlicensed) These may be used where there are swallowing difficulties as the capsule can be opened and the contents sprinkled on cold food.
Responsibilities of the specialist initiating treatment


  • To assess the suitability of the patient for treatment and confirm that a full trial of behavioural management has been attempted and failed to achieve satisfactory results.

  • Assess the nature and severity of the sleep disorder where possible by review of the patient’s sleep diary.

  • To discuss the benefits and side effects of treatment with the patient/carer and the need for long term monitoring before initiating treatment

  • To obtain consent from the patient/parents/carer as applicable.

  • To check for drug interactions with concurrently prescribed medication

  • To conduct baseline monitoring to include height weight and puberty

  • To initiate treatment and adjust according to patient response.

  • Prescribing until treatment is stable.

  • To review the patient in clinic, regularly until optimum dose is established then 6- 12 monthly reviews.

  • To initiate a trial reduction in medication if considered appropriate, this is usually after a period of stability for the child and their environment of about six months

  • To adjust the dose and formulation of the drug as required and communicate this information to the GP.

  • To monitor the patient for adverse events and report to the GP and where appropriate Commission on Human Medicines/MHRA (Yellow card scheme).


Information to be received by the GP from the Consultant


Summary

Baseline Tests

Height and Weight



Routine Tests

Monitoring of height and weight is required annually, this would usually be conducted at secondary care reviews.



Disease monitoring

Patients are reviewed regularly until the optimum dose is established. Following this patients are reviewed every 6 to 12 months.





Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician

It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on shared care only if they are willing and able.


Summary

  • To reply to the request for shared care as soon as possible.

  • To prescribe and adjust the dose as recommended by the specialist.

  • To ensure there are no interactions with any other medications initiated in primary care.

  • To continue monitoring as agreed with secondary care (guideline should include details of monitoring requirements and what to do when each of the defined parameters alters).

  • To refer back to the specialist where appropriate. For example:

    • Patient or general practitioner is not comfortable to continue with the existing regime due to either change in condition or drug side effects.

    • Advice in respect of concordance.

    • Special situations, (e.g. Pregnancy).

  • Discontinue the drug as directed by the specialist if required.

  • To identify adverse events if the patient presents with any signs and liaise with the hospital specialist where necessary. To report adverse events to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme).




Clinical Particulars


BNF therapeutic class





Cautions and Contraindications


  • Epilepsy - When using melatonin in patients with epilepsy, seizure frequency should be monitored

  • The manufacturer’s of Circadin® state that it should not be taken in patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption.

  • It is not recommended in patients with autoimmune diseases.

  • Pregnancy – In view of the lack of clinical data, use in pregnant women or women intending to become pregnant is not recommended. It is recommended that you contact the medicines information department at the local hospital for the most up to date information and advice.

  • Breast feeding As it is likely melatonin is excreted in breast milk, use of melatonin during breast feeding is not recommended.

Adverse Drug Reactions

  • Melatonin is generally well tolerated with some reports of head ache and

  • sedation.

  • The adverse effects of controlled release melatonin are not expected to differ to those from the standard release preparations.

  • Melatonin may affect the reproductive system by inhibiting the hypothalamic-pituitary-gonadal axis. When starting long term melatonin it is worth mentioning that there is a theoretical possibility of delaying puberty. Parents should be advised to report any concerns, which following examination could result in referral to a paediatric endocrine clinic. Information could be reinforced in a medication leaflet.

The effect of melatonin seizure activity is unclear. According to one study it may have a pro -convulsant effect. However this adverse effect is difficult to prove considering a large number of the patients receiving melatonin have a pre-existing seizure disorder.

Clincally relevant Drug Interactions and their management


There is a paucity of clinical data in this regard. Bioavailability may be increased with fluvoxamine. Blood pressure control may be affected on patients controlled with nifedipine.

Circadin®: manufacturer advises avoid use with fluvoxamine as concomitant use

results in large increases of melatonin plasma concentration. Manufacturer also

advises caution with cimetidine, cigarette smoking, oestrogens, quinolones,

carbamazepine, rifampicin, benzodiazepines and z-hypnotics such as zopiclone and zolpidem. For full details refer to product SPC.
On initiation of melatonin the specialist will be responsible for checking interactions and making necessary alterations in treatment. If a patient is started on any of these medications contact the specialist for advice.




Communication


Specialist to GP

The specialist will inform the GP when they have initiated drug Melatonin. When the patient is near completing the satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and where possible give an indication as to the expected length of treatment. The Specialist will also send a Shared care request form to support the GP in undertaking reduced shared care. (Appendix A)


GP to specialist

If the GP has concerns over the prescribing of drug Melatonin, they will contact the specialist as soon as possible.


Contact names and details

Contact Details

Telephone No

Fax No

Email

Child and Adolescent Consultant Psychiatrists:

Dr Andrew Charters

Dr Anna Kucharska

Dr Anita Coan, Specialty Doctor

Dr Aly Middleton, Specialty Doctor

Jo Newing, ADHD Advanced Nurse



All contactable at New Street Clinic

01226 433163


01226 433194





Andrew.charters@swyt.nhs.uk

Anna.kucharska@swyt.nhs.uk

Anita.coan@swyt.nhs.uk

Aly.middleton@swyt.nhs.uk

Jo.Newing@swyt.nhs.uk


Community Paediatricians:

Dr Mathew Periappuram 


01226 433131 



01226 202259  

mathewperiappuram@nhs.net

Dr Ruth Caudwell


01226 433184



01226 202259

ruth.caudwell@nhs.net

Dr Saqib Iqbal


01226 433184



01226 202259

saqib.iqbal@nhs.net

Dr Shobha Sivaramakrishnan

01226 433184



01226 202259

shobha.sivaramakrishnan@nhs.net


Dr Mahmud Tumi

01226 433184



01226 202259

mtumi@nhs.net


Barnsley Hospital Foundation Trust Medicines Information

01226 432857

01226 434431

GilllianSmith2@nhs.net


Sarah Hudson, Lead Pharmacist, BBDU, SWYPFT

01226 434649




Sarah.hudson@swyt.nhs.uk

Chris Lawson, Head of Medicines Optimisation, Barnsley CCG

01226 433798




Chris.lawson@nhs.net






References

Current edition of BNF and BNF C http://bnf.org


NICE Guidance www.NICE.org.uk
Further information is available on www.choiceandmedication.org/swyp and from med.information@swyt.nhs.uk tel 01924 327619
Medicines for children - information for parents and carers – Melatonin for sleep disorders http://www.medicinesforchildren.org.uk/search-for-a-leaflet/melatonin-for-sleep-disorders/
Useful resources for parents and health care professionals can be found at www.autism.org.uk and www.early-years.org

Appendix A – Shared Care request form (Amber)


  • Specialist to complete when requesting GP to enter a shared care arrangement.

  • GP to return signed copy of form. 

  • Both parties should retain a signed copy of the form in the patient’s record.


From (Specialist): To (GP):
Patient details

Name: ID Number:


Address: DOB:

Diagnosed condition:







Amber Drug details

Drug name: Dose:


Date of initiation: Length of treatment:
The patient will be reviewed by the Consultant on:
The patient should be reviewed by the GP by:


Telephone number(s) for contact:
Consultant: Date:

Monitoring

The following monitoring should be undertaken by the GP:


Parameter


Date next test due

Frequency





















































Communication


Consultant

Telephone number: Fax number:


Email address:
Specialist Nurse

Telephone number: Fax number:


Email address:




Confirmation of acceptance of shared care

Specialist (Doctor/Nurse) name:

Specialist (Doctor/Nurse) signature: Date:
I, Dr …………………………….., can confirm I :

□ accept the request to participate in shared care for the patient named above.


□ reject the request to participate in shared care for the patient named above. The reason for
this being ………………………………………………………………………………………..

GP signature: Date:







Page of
Melatonin Shared Care Guideline
Date Prepared: December 2014 Review Date: December 2016


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