| Formulary Chapter 4: Central nervous system - Full Chapter
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| Chapter Links... |
MHRA Drug Safety Alert (Feb 2015): Drugs and driving: blood concentration limits set for certain drugs |
NENC Palliative and End of Life Care Symptom Control Guidelines |
NICE NG62: Cerebral palsy in under 25s: assessment and management |
TEWV - Medicines Optimisation – Interactive Guide |
TEWV Guidelines |
TEWV Safe Transfer of Prescribing Guidance |
| Details... |
| 04.01.01 |
Hypnotics |
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Melatonin
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Formulary
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- 2mg modified-release tablets (prescribe generically)
- 1mg, 2mg, 3mg, 4mg, 5mg tablets (Adaflex®, crushed if necessary)
restricted use: 1mg/ml oral solution (Consilient brand)
NB: Slenyto is no longer approved. Patients should be reviewed at their next routine follow-up, see separate entry
Approved Indications
- Insomnia (short term use – Max 13 weeks) adults 55 years and over

- Delayed sleep phase syndrome and other circadian rhythm disorders (including visually impaired/blind people with disturbed sleep wake cycles)
- Patients with injurious parasomnia including REM sleep behaviour disorder (RBD) [e.g with degenerative conditions such as Parkinsonian disease or dementia]
- Sleep conditions in patients with learning disabilities and behaviour that challenges (where sleep hygiene measures have been insufficient)
- Neurological or behavioural disorders including:
- Attention deficit hyperactivity disorder (ADHD)
- Autism Spectrum Disorder (ASD)
- Neurodevelopmental disabilities
- Cluster headache
- Prior to examinations as directed by paediatric specialists (such as a sleep encephalogram (EEG) & sedation prior to scans)
- Critical care short term sleep disturbance [Hospital use only]
Indications not listed on the formulary are not routinely supported for prescribing e.g. sleep disturbances related to shift work, Alzheimer's disease, chronic fatigue syndrome / myalgic encephalomyelitis / encephalopathy, sleep apnoea, as an adjunct to hypnotic withdrawal and jet lag (unless an approved indication co-exists)
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Benzodiazepines |
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Temazepam
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Formulary
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Zaleplon, Zolpidem and Zopiclone |
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Zolpidem
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Formulary
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MHRA Drug Safety Update (May 2014): Zolpidem: risk of drowsiness and reduced driving ability
NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
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Zopiclone
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Formulary
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- To be used in accordance with NICE criteria
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NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
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| 04.01.01 |
Chloral and derivatives |
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Chloral Hydrate
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Formulary
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MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
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Chloral Hydrate 500mg in 5ml mixture
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Formulary
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MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
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| 04.01.01 |
Clomethiazole (Chlormethiazole) |
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Clomethiazole
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Formulary
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- Alcohol withdrawal - chlordiazepoxide is preferred in the management of alcohol withdrawal.
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Antihistamines |
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Promethazine Hydrochloride
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Formulary
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| 04.01.01 |
Daridorexant |
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Daridorexant (Quviviq® )
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Formulary
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- 25mg and 50mg tablets
- Approved for the treatment of long-term insomnia in line with NICE via NHS Sleep Clinics at
- Northumbria Healthcare NHS Foundation Trust;
- South Tees Hosptials NHS Foundation Trust; and
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- First 3 months supply from secondary care with a review at 3 months. If effective, transfer to primary care with a further 1 month supply from secondary care to allow for handover
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NICE TA922: Daridorexant for treating long-term insomnia
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| 04.01.01 |
Sodium oxybate |
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Sodium Oxybate 500mg/1ml oral solution
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Formulary
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- 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
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Clinical Commissioning Policy: Sodium oxybate for symptom control of narcolepsy with cataplexy (children and adolescents aged 7 until 19 years)
NTAG - Treatment Appraisal Decision Summary - Sodium Oxybate
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| 04.01.01 |
Pitolisant |
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| Non Formulary Items |
Melatonin (Slenyto®) (1mg and 5mg modified-release tablets)

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Non Formulary
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Not considered a cost-effective formulation.
Patients should be reviewed at their next routine follow-up. |
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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Description |

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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. |

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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic.
The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible.
SCGs are available or are being developed for most of the drugs listed as AMBER. |

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Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria.
These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary.
In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary.
If the drug requires urgent initiation, it is expected that the specialist provides the first prescription from the inpatient/outpatient setting, of sufficient supply for a patient’s immediate needs. The quantity provided should cover at least up to the point where the discharge/clinic letter has reached the GP, plus reasonable time for the practice to manage the document and issue further supplies. A GREEN+ drug can only be recommended to primary care for initiation if it does not need to be initiated urgently, taking into account clinical need. |

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Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible. |

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Self-care – available OTC, can be purchased as part of self-care for self-limiting conditions as per NHSE policy guidance |

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

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Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care. |
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