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 Formulary Chapter 4: Central nervous system - Full Chapter
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04.01.01  Expand sub section  Hypnotics
Melatonin
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Formulary
  • First line: melatonin 1mg and 5mg modified release tablets in line with licensed indications only.
  • Second line: melatonin 1mg, 2mg, 3mg, 4mg and 5mg tablets (crushed if necessary).
  • Third line: melatonin 1mg/1ml oral solution (alcohol-free) - for patients unable to use crushed tablets

Approved Indications

Melatonin can be used to facilitate the induction of sleep, and increase the duration of sleep on the advice of an appropriate secondary care specialist, in the following situations:

1) Visually impaired or blind people with disturbed sleep wake cycles. Green plus
2) Delayed sleep phase syndrome and other circadian rhythm disorders.Green plus
3) Children with neurological or behavioural disorders including: Amber

  • Attention deficit hyperactivity disorder (ADHD).*
  • Chronic sleep onset insomnia.*
  • Neurodevelopmental disabilities (e.g. involving delayed brain maturation, sensory dysfunction - especially visual and dysfunction of sleep centres).*

4) Treatment of children and young adults with chronic fatigue syndrome / myalgic encephalomyelitis who have sleep difficulties (as recommended in NICE clinical guideline no. 53).* Amber
5) Prior to examinations such as a sleep encephalogram (EEG) in children and sedation prior to scans in paediatric oncology. Green plus
6) Patients with REM sleep behaviour disorder (RBD) - e.g. associated with degenerative conditions such as Parkinson’s disease or dementia, as a second line treatment to clonazepam. Green plus
7) To improve nocturnal sleep in critically ill patients (to aid weaning from mechanical ventilation) Green plus

*Note that for indications 3 and 4 in children and young people melatonin is classified as an ‘amber’ drug and therefore subject to formal shared care guidance.  Please follow relevant link below for the most recent guideline.

 
Link  Tees, Esk and Wear - Melatonin Shared Care Guideline
Link  North of Tyne, Gateshead and North Cumbria - Melatonin for the management of Sleep – Wake Disorders in Children and Young People
Link  North of Tyne, Gateshead and North Cumbria - Melatonin Deprescribing Guideline (March 2022)
 
04.01.01  Expand sub section  Benzodiazepines
Controlled Drug Temazepam
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First Choice
Green
 
04.01.01  Expand sub section  Zaleplon, Zolpidem and Zopiclone
Zolpidem
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Formulary
Green
 
Link  MHRA Drug Safety Update (May 2014): Zolpidem: risk of drowsiness and reduced driving ability
Link  NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
 
Zopiclone
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Formulary
Green
  • To be used in accordance with NICE criteria
 
Link  NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
 
04.01.01  Expand sub section  Chloral and derivatives
Chloral Hydrate
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Formulary
Red
 
Link  MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
 
Chloral Hydrate 500mg in 5ml mixture
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Formulary
Red
 
Link  MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
 
04.01.01  Expand sub section  Clomethiazole (Chlormethiazole) to top
Clomethiazole
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Formulary
Green

  • Alcohol withdrawal - chlordiazepoxide is preferred in the management of alcohol withdrawal.

 
 
04.01.01  Expand sub section  Antihistamines
Promethazine Hydrochloride
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Formulary
Green
 
 
04.01.01  Expand sub section  Daridorexant
Daridorexant (Quviviq® )
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Formulary
Green plus
  • 25mg and 50mg tablets
  • Approved for the treatment long-term insomnia in line with NICE via NHS Sleep Clinic at
    • South Tees Hosptials NHS Foundation Trust; and 
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • First 3 months treatment to be provided by secondary care followed by a review and a further 1 month supply if appropriate before prescribing is handed over to primary care
 
Link  NICE TA922: Daridorexant for treating long-term insomnia
 
04.01.01  Expand sub section  Sodium oxybate
Controlled Drug Sodium Oxybate 500mg/1ml oral solution (Xyrem®)
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Formulary
Red
High Cost Medicine
  • Approved for the treatment of narcolepsy with cataplexy in children age 7 years and above only in accordance with NHS England clinical commissioning policy.
  •  The Northern (NHS) Treatment Advisory Group recommends the use of sodium oxybate in adult patients who have received and benefited from treatment with sodium oxybate as commissioned by NHS England. i.e. continuing treatment for those >19 years old.
  • The Northern (NHS) Treatment Advisory Group also recommends sodium oxybate for use in adults who have not received it as a child as per the RMOC criteria, noting that may sometimes be used in combination with other agents.
  • The following criteria for use in adults who have not received sodium oxybate as child apply:
    • Patients presenting with narcolepsy with cataplexy according to International Classification of sleep disorders 3 (ICSD) criteria for Narcolepsy Type 1 AND
    • Patients ≥ 19 years old AND
    • Where patients have co-morbidities, which are also affecting sleep, these should be managed and adequately treated (for example moderate to severe obstructive sleep apnoea or restless legs syndrome) AND
    • Failure to respond to non-pharmacological treatments consisting of behavioural and environmental adaptations, for example planned naps AND
    • Inadequate response (within 3 months) to, or intolerable adverse effects from, or contra-indicated use of, more than one stimulant for narcolepsy, and more than one anticataplectic agent AND
    • Assessed as being able to benefit from sodium oxybate via a specialist sleep centre.
  • Sodium oxybate is generally considered as a final treatment option for patient
 
Link  Clinical Commissioning Policy: Sodium oxybate for symptom control of narcolepsy with cataplexy (children and adolescents aged 7 until 19 years)
Link  NTAG - Treatment Appraisal Decision Summary - Sodium Oxybate
 
04.01.01  Expand sub section  Pitolisant
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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