• 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 - 1st choice for patients unable to tolerate solid dose formulations. Consilient Health formulation to be used as it is alcohol and propylene glycol free

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. 
2) Delayed sleep phase syndrome and other circadian rhythm disorders.
3) Children with neurological or behavioural disorders including: 

• 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).* 
5) Prior to examinations such as a sleep encephalogram (EEG) in children and sedation prior to scans in paediatric oncology. 
6) Patients with injurious parasomnia including REM sleep behaviour disorder (RBD) – e.g associated with degenerative conditions such as Parkinson’s disease or dementia, as an alternative to clonazepam.
7) To improve nocturnal sleep in critically ill patients (to aid weaning from mechanical ventilation) 

*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.

Until the availability of ICB-wide approved guidance, links to previously agreed local guidance are provided within the formulary. Queries relating to local guidance should be directed to the guidance authors.

Tees, Esk and Wear - Melatonin Shared Care Guideline

North of Tyne, Gateshead and North Cumbria - Melatonin Deprescribing Guideline (March 2022)

CNTW Shared Care Guideline - Melatonin for the management of Sleep – Wake Disorders in Children and Young People

• To be used in accordance with NICE criteria

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

• 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

• 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

• Approved for the control of deviant antisocial sexual behaviour

•  Palliative Care

•  For use in palliative care.
  • Levomepromazine 25mg in 1ml injection is approved for use in palliative care. 
• Note: Methotrimeprazine / Levomepromazine 6mg tablets are unlicensed

• Note: risperidone orodispersible tablets should only be used in situations where the plain tablets are unsuitable.

• Approved for schizophrenia in people aged 15 to 17 years in line with NICE.


• Approved for moderate to severe manic episodes in young people aged 13 and older with bipolar I disorder NICE.


• Aripriprazole 10mg & 15mg orodispersible tablets are approved for doses over 5mg for those patients who have difficulty swallowing.


• Aripiprazole 1mg in 1ml oral solution is only for doses of 5mg or less, or when titrating patients on doses of increments of less than 5mg, in patients who have difficulty swallowing tablets.


• To be used in accordance with NICE criteria.


• Note: Aripiprazole 7.5mg/ml IM Injection is approved for use in rapid tranquilisation in patients with acute psychosis.  NTW use only.

• First choice in patients with treatment-resistant schizophrenia. 

• Contact CNTW Pharmacy for continued supply on admission and discharge
• TEWV Clozapine Information & Guidance

• 18.5mg, 37mg and 74mg tablets


• Approved for the treatment of schizophrenia in adults and adolescents aged 13 years and over 

• Olanzapine orodispersible tablets should only be used in situations where the plain tablets are unsuitable. 

• Olanzapine orodispersible tablets and injection are also approved for 2nd/3rd- line use in the management of delirium in critical care patients unlicensed indication. 

•  10 mg injection 
  • for rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate.
  • for delirium at end of life 

• 210mg, 300mg & 405mg powder and solvent for suspension for long-acting injection (as olanzapine embonate monohydrate) 
  
  
  • approved for the treatment of schizophrenia in adults within secure psychiatric services
  
  
  

• 25mg, 100mg, 150mg 200mg & 300mg tablets 


• 50mg, 200mg, 300mg & 400mg prolonged release tablets  
  
  
  
  
  • Prolonged release tablets are approved for use in patients who require an outside carer to administer their medicines, and for short term use when rapid dose titration is considered important e.g. where its use might avoid the need to admit the patient to hospital.
  
  
  
  


• Quetiapine 20mg/ml Oral Suspension (Rosemont) - CNTW only  

•  CNTW
•  TEWV
• Approved for the treatment of psychosis and schizophrenia in line with NICE guidance

•  CNTW
•  TEWV

•  CNTW
•  TEWV

•  CNTW
•  TEWV
• The above applies to the monthly and 3-monthly preparations ONLY. 
• CNTW and TEWV currently do not support the use of the 6-month preparation.
• Approved for the treatment of psychosis and schizophrenia in line with NICE guidance

•  CNTW
•  TEWV
• Only for use by psychiatrists in accordance with NTAG guidelines.

• For short-term use by NTW.

• Sodium valproate 200mg, 300mg, and 500mg (Epilim Chrono®) tablets are approved for the prevention and treatment of manic episodes associated with bipolar disorder (unlicensed indication). May be useful in patients unresponsive to lithium. 

Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) 

Black Triangle in females

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)

• Licensed alternative to sodium valproate MR tablets. 

Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) 

▼Black Triangle in females

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)

• Prescribe by brand name.

• Prescribe by brand name.

• Safer than amitriptyline in overdosage, but not as effective.

• For use on advice from psychiatrists only.

• For use on advice from psychiatrists only.

• NETAG approved for the treatment of depression only following an adequate trial of at least three alternative antidepressant drugs at maximally tolerated doses (as described by NICE and as stated in the BNF).
• Prescribing and monitoring should be initiated by specialist mental health physicians. 
  • Transfer of prescribing to primary care at around 6 months / when LFT monitoring completed following dose increase

• 150mg prolonged release tablets
• Resistant depression 

• For use on advice of psychiatrists as a third-line antidepressant - but only for use in patients who cannot tolerate high-dose (>150mg daily) venlafaxine, or patients with hypertension, established CHD or other cardiovascular risk factors which would make the use of high-dose venlafaxine undesirable.
• Also approved for third-line use (after drugs such as the tricyclic antidepressants and gabapentin) in the treatment of neuropathic pain on the advice of pain specialists.

• Orodispersible mirtazapine tablets should only be prescribed for use when other formulations are unsuitable (more expensive).

•  Not licensed in the elderly

• For patients on doses of 300mg/day or more. 

• Only approved for use in accordance with NICE guidance. 

• Please prescribe by brand name
• 5mg & 10mg tablets
• 5mg, 10mg, 20mg, 30mg and 40mg m/r capsules (Medikinet® XL)
• 10mg, 20mg & 30mg m/r capsules (Equasym® XL)18mg, 27mg & 36mg m/r tablets (Xaggitin® XL)
  
  • Existing patients who are prescribed Concerta® XL should be reviewed and switched to Xaggitin® XL as appropriate
  • Xaggitin® XL is bioequivalent to Concerta® XL
• 2mg/ml oral solution sugar free (Consilient Health Ltd). Only for those patients unable to take solid dosage forms across the whole dosage range. This preparation contains the following excipients with known effect: Propylene glycol 90mg/ml, Sorbitol 175mg/ml, Sodium benzoate 1mg/ml NPPG Position statement ‘Choosing an Oral Liquid Medicine for Children’ advises on maximum content of propylene glycol and benzoates dependent on age.
• Approved for ADHD and the treatment of narcolepsy in adult and paediatrics.
• Approved for improving working memory and processing speed following neurocognitive damage secondary to brain injury from; a brain tumour and its associated treatment (e.g. hydrocephalus and radiotherapy) or neurotoxic chemotherapy.

• MHRA Drug Safety Update (Sep 2022): Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulations

• 10mg, 18mg, 25mg, 40mg, 60mg, 80mg & 100mg capsules
• 4mg/1ml oral solution - approved for patients with more complex needs e.g. younger patients and those with swallowing difficulties.

• 5mg, 10mg and 20mg tablets
  • ADHD
  • Narcolepsy
  • Doses up to 60mg daily 

• 20mg, 30mg, 40mg, 50mg, 60mg & 70mg capsules
  • For third line use and specialist initiation. Should only transferred to GPs after at least three month stable symptom control
  • Approved for the treatment of ADHD in adults

• Approved for:
  
  • treatment of patients with narcolepsy
  • treatment of idiopathic hypersomnia
  
  
  

• 75mg and 150mg tablet
  • Approved for treating excesive daytime sleepiness caused by narcolepsy in line with NICE

• Approved for use in patients with narcolepsy who experience psychomotor side effects with modafinil and dexamfetamine.
• To be used in line with NTAG

• 1mg, 2mg, 3mg & 4mg prolonged release tablets
  • Approved for use in children and adolescents when 1st line stimulants and atomoxetine are contraindicated or ineffective.
  • Can also be prescribed in primary care by GPs in adults who started treatment in childhood and wish to continue, for whom stimulants are not suitable, not tolerated or have been shown to be ineffective under specialist supervision

• Only approved for use in accordance with NICE guidance. 

• Palliative care use

• Palliative care use

• Doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg tablets
  • Approved for use in nausea and vomiting in pregnancy in line with RCOG guidelines.   

• Note: Buccastem® 3mg tablets are only approved for the treatment of nausea associated with migraine when the oral route cannot be used due to vomiting.

• Please refer to MHRA advice 

• Approved for use as a galactagogue to re-establish breastfeeding on specialist advice and following a cardiovascular risk assessment in light of MHRA advice.

• Only approved for the second line treatment of chemotherapy induced nausea vomiting only.

• To be used in accordance with Northern England Strategic Clincial Cancer Network (NCCN) Guidelines

• For the prevention of chemotherapy induced nausea and vomiting (CINV) in high risk patients in accordance with North of England Cancer Network: CINV Guidelines in adult oncology and haematology patients
• Off label use in children under 12yrs / longer term use, when required, for the prevention of nausea and vomiting in paediatric patients undergoing haematopoietic stem cell transplantation (HSCT).

• For the prevention of chemotherapy induced nausea and vomiting (CINV) in high risk patients in accordance with North of England Cancer Network: CINV Guidelines in adult oncology and haematology patients

• 100mg/1mL oral solution
  
  
  
  • Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
  
  
  • Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
  
  
  
  

• For the management of excessive secretions where tablets are unsuitable.

• Oral diclofenac is restricted to short-term use for post operative pain.
• If long-term use is required diclofenac is only approved for 4th line treatment (see below):
  
  • Ibuprofen low dose – first line treatment.
  • Naproxen low dose – second line treatment.
  • Naproxen high dose – third line treatment.
  • Diclofenac – fourth line treatment.

First line

• 15mg tablets

Second line

• 30mg tablets

The following codeine preparations are unlicensed and approved for use:

• 30 mg suppositories.
• codeine 2mg, 3mg, 6mg, 15mg;
• codeine 30mg in 1ml injection 

Modified release

• 10mg, 30mg, 60mg, 100mg, 200mg MR capsules(Zomorph^®) - 1st choice modified release preparation
• 5mg, 10mg, 15mg, 30mg, 60mg, 100mg, 200mg MR tablets (MST^®) - 2nd choice modified release preparation

Immediate release

• 1mg, 2.5mg, 5mg, 10mg, 20mg & 30mg oro-dispersible tablets (Actimorph^®) - 1st choice immediate release preparation
• 10mg in 5ml oral solution- 2nd choice immediate release preparation 

Injection

• 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml injection

Other approved formulations

• 100 micrograms/1 ml oral solution. For use in neonates  unlicensed
• morphine 5mg in 1ml injection  unlicensed 
• 10mg in 1ml preservative free injection  unlicensed
• 2mg in 5ml epidural  unlicensed
• 50mg in 50ml PCA injection 

• Palliative care use  
• 500micrograms in 1ml [ST&S], 1mg in 2ml, 5mg in 10ml & 5mg in 1ml injection ampoules - approved for initiation by specialists in palliative care  
• All non-palliative care indications 

•  Unlicensed intranasal diamorphine is approved for use in children for the relief of severe pain due to clinically suspected limb fractures, burns and significant fingertip injuries. Appropriate risk assessments are to be conducted by each organisation in order to determine formulation of choice (e.g. ampoules or intranasal spray).

• Note: intranasal diamorphine   

• 30 microgram sublingual tablets
• Approved for use during dressing changes in burns patients.
• Trusts that use this product should review its use after 6 months and submit the results to the FWG.

• 50mg capsules, 50mg dispersible tablets & 100mg/2ml injection
• Only approved for use as a second-line weak opioid analgesic for use in patients where treatment with possible alternatives such as paracetamol, NSAIDs, and codeine is insufficiently effective, not tolerated or considered unsuitable for other reasons.
• Note: modified release tramadol is not approved or recommended. 
• Note: tramadol and paracetamol combination products are classified as BLACK - not approved for use

• 200microgram sublingual tablets
• 300microgram in 1ml injection
• Buprenorphine patches (Preferred brand - Butec®) are approved for use in palliative care when fentanyl 12 microgram/hr transdermal patches exceed the patient’s analgesic requirements.

• 12, 25, 37.5, 50, 75 & 100 microgram/hour transdermal patches
  • Prescribe by brand. Mezolar® has replaced Matrifen® as the first choice brand. Patients who currently use Matrifen® can continue to do so if managing well.
• Fentanyl sublingual tablets (Abstral®)   restricted to use for breakthrough / rescue pain relief in palliative care on recommendation of a pain specialist or palliative care team.
• nasal spray 
  • approved for use in children during diamorphine shortage with appropriate local governance arrangements

The following preparations are approved:

• 5mg tablets;
• 5mg in 5ml mixture DTF & 5mg in 5ml sugar free solution
• 20mg in 1ml concentrated oral solution (unlicensed)
• 10mg in 1ml injection

• Approved only for use in patients who are intolerant of morphine. 

• Note: Oxycodone 50mg in 1ml injection  is also approved for use, but is restricted to controlled circumstances in palliative patients following risk assessment by individual organisations.

• Approved for use as part of Enhanced Recovery After Surgery (ERAS) as part of multi-modal enhanced recovery pathway following hip and knee surgery 

• The OxyPro® branded generic is preferred (most cost effective option). 

• The oral solution should be used instead of immediate release tablets. 

• Approved for use by chronic pain specialist in adults with severe pain who have been screened for a neuropathic element to their pain and are uncontrolled or experiencing GI side effects on existing therapy.

• Note: the use of dihydrocodeine 30mg tablets & 10mg in 5ml oral solution is no longer recommended for regular use. Codeine is the preferred weak opioid analgesic.
• Dihydrocodeine is only approved for use in antenatal from 36 weeks and postnatal patients immediately postdelivery / c-section where adequate pain relief has not been achieved using paracetamol and NSAIDs. Commencing during in-patient admission with up to 14 days prescribed and dispensed on discharge as a take home medication.

• For use in the treatment of neuropathic pain
• Gabapentin is also approved for hospital use  as an adjunct to other treatment in the management of peri/post-operative pain.  unlicensed
• GPs should not be asked to prescribe gabapentin for this unlicensed indication.
• Approved for intractable itch with severe burns 

• Pregabalin is restricted to use in the management neuropathic pain as a second choice where treatment with gabapentin has been unsuccessful or not tolerated.

• 100 units injection
• Prescribe by brand name.
• Approved for the treatment of myalgia temporomandibular disorders (M-TMD) and orofacial neuropathic pain (OFNP).

• Restricted use in treatment of trigeminal neuralgia only.

• For third-line use (after drugs such as the tricyclic antidepressants and gabapentin) in the treatment of neuropathic pain on the advice of pain specialists.

• Qutenza® cutaneous patch approved for the treatment of neuropathic pain as fourth line agent for neuropathic pain and in line with the attached regionally agreed pathway. 


• 0.075% cream (Axsain®) approved for post hepatic neuralgia and peripheral diabetic neuropathy 

• Only for use in the treatment of post-herpetic neuralgia only on the advice of pain specialists and subject to an appropriate trial of efficacy in each individual patient.

• Please refer to Chapter 04.07.01

• Used to help promote absorption of analgesics.

• MHRA Drug Safety Update (July 2022): Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure

• 10mg and 60mg tablets
  • Approved for preventing migraine in line with NICE:
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed
    • 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.

• Clonidine is not generally recommended for migraine prophylaxis; may aggravate depression/cause insomnia.

• 100mg/1ml concentrate for solution for infusion
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 70mg/1ml and 140mg/1ml solution for injection (pre-filled pens)
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 225mg/1.5ml solution for injection (Pre-filled pens/syringes)
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed
    
    
    

• 120mg/1ml injection
  
  • Approved for the prevention of chronic migraine in adults in line with NICE only if
    • they have 4 or more migraine days a month
    • at least 3 preventative drug treatments have failed

• 75mg oral lyophilisates
  • Approved for preventing migraine in line with NICE 
    • 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.
    • Approved for treating migraine in line with NICE 

• Only approved for use in accordance with NICE guidance. 

• Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) are also approved for use in those who have difficulty swallowing sodium valproate tablets. MR granules may be more convenient to use than large volumes of liquid formulations.

Black Triangle in Females

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)  

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)

• Lithium should be prescribed by brand name.

• Lithium should be prescribed by brand name.

• Approved for use as adjunctive therapy in patients with severe/intractable partial onset seizures e.g. a sezuire frequency of 1 per week following failure of first-line adjunctive therapy. Response must be assessed within 3-6 months before transferring prescribing to primary or stopping treatment, as appropriate.

• 100mg/1mL oral solution
  • Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
  • Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
  • Approved as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over - in line with NICE TA873.

• Carbamazepine 200mg and 400mg MR tablets (Tegretol® retard) are available on consultant request for those in whom conventional carbamazepine has been shown to be unsuitable 

• 125 mg and 250 mg suppositories

• Note: licensed for short-term use as replacement therapy (maximum period recommended: 7 days) in patients for whom oral treatment is temporarily not possible, for example in post-operative or unconscious subjects.

• Clonazepam 500microgram in 5ml sugar-free oral solution is also approved unlicensed

• Approved for use by specialists only in those patients for whom intolerance of carbamazepine is a major concern and when use of this agent is more cost effective than alternatives available.

• Oral solution: 2.2mg/mL
• Approved for treating seizures associated with Lennox–Gastaut syndrome (LGS), as an add-on to other antiseizure medicines, for people 2 years and over in line with NICE.
• Approved as an add‑on to other antiseizure medicines for treating seizures associated with Dravet syndrome in people aged 2 years and older in line with NICE

• Note: gabapentin 250mg in 5ml is also approved unlicensed.

• Only approved on advice from consultant neurologists, in patients that are refractory to treatment with other drugs.

• Injection is also approved for use in palliative care 

• NETAG approved for partial (focal) seizure epilepsy only when other treatment  options recommended by NICE have been tried or fully considered.

• 15mg/5ml oral solution
  • not suitable for use in children
• 50mg/5ml alcohol free oral solution e.g. Rosement (unlicensed)
  • to be used for all children (<18yrs) who require a liquid preparation. 

• Note: phenytoin 30mg in 5ml suspension (base) – 90mg (15ml) is equivalent to one 100mg phenytoin sodium capsule 250mg in 5ml injection (sodium salt).

• Approved for specialist advice in the management of treatment resistant epilepsy. 
• Also approved as a second line agent for General Anxiety Disorder. Although treatment can be given 2-3 times daily, it is more cost effective to give as a twice daily dose. 

• Approved for limited use as a second or third-line treatment in patients with Lennox-Gastaut syndrome and related encephalopathies.
• Should only be used on the advice of paediatric neurologists and other neurologists specialising in the treatment of epilepsy.

• Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) - for possible use in those who have difficulty swallowing sodium valproate tablets. May be more convenient to use than large volumes of liquid formulations.
• Valproate▼ must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) 

▼ BLACK TRIANGLE IN FEMALES

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA Drug Safety Update January 2024)

Valproate use in men: as a precaution, men and their partners should use effective contraception (MHRA Drug Safety Update September 2024)

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. (MHRA Drug Safety Update February 2025)

• For use as adjunctive therapy of refractory generalised tonicclonic seizures in children with severe myoclonic epilepsy in infancy.

• For use only in patients that are refractory to treatment with other drugs on the recommendation of a specialist

• Use in children is unlicensed.

• 12.5mg, 25mg, 50mg, 100mg, 150mg and 200mg tablets


• Approved for treating focal onset seizure in epilepsy in line with NICE
  
  
  
  • Patients will be stabilised by the epilepsy specialist prior to transfer to the GP for continuation. This will usually be after 3 months of treatment.
  
  
  
  

Prescribe by brand

Status epilepticus in children aged 3 months to 18 years.

• First Choice
• Buccolam® pre-filled oral syringes (2.5mg/0.5ml, 5mg/1ml, 7.5mg/1.5ml and 10mg/2ml)
• Alternative
• Epistatus® oromucosal solution pre-filled oral syringes (10mg in 1ml)
• Use in patients under 3 months is off-label. 

Status epilepticus in adults (>18 years)

• Buccolam® pre-filled oral syringe (10mg/2ml only)
• Epistatus® oromucosal solution pre-filled oral syringes (10mg in 1ml)

Buccolam® products are alcohol free

Injection solutions (section 15.1.4) can also be given buccally - This use is off-label

• For initiation by neurologists only.

• For initiation by neurologists only.


• Lorazepam  2mg/ml suspension & 4mg/ml suspension are also approved but are unlicensed.


• Buccal administration of lorazepam suspensions are only approved for use in paediatrics in children with status epilepticus in whom buccal midazolam, rectal paraldehyde or rectal diazepam are ineffective.

• For initiation by neurologists only.

• For initiation by neurologists only.

Paracetamol suppositories

• unlicensed preparations include 15mg, 30mg, 60mg, 120mg, 240mg, and 500mg. These are used in NUTH.


• Licensed preparations include 60mg, 125mg, 250mg, and 500mg suppositories are available in primary care.

• foslevidopa 240mg/foscarbidopa 12mg in 1ml solution for infusion
• Approved for the treatment advanced Parkinson’s with motor symptoms in adults in line with NICE and NHSE Specialised Commissioning Policy

• levidopa 20mg/carbidopa 5mg intestinal gel
• Approved for the treatment of Parkinson's disease
• Please note that only the following providers are commissioned to provide this service within North East & Yorkshire: NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST, SOUTH TEES HOSPITALS NHS FOUNDATION TRUST, THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST, and LEEDS TEACHING HOSPITALS NHS TRUST

• 50mg and 100mg tablets
• Approved for use in Parkinson's Disease patients on levodopa who are having motor fluctuations affecting their quality of life as an alternative to rasagiline.

• 5mg/1ml (20ml) solution for infusion for infusion pumps & 10mg/1ml (3ml) solution for injection cartridges (Dacepton®) 

• 30mg/3ml solution for injection (APO-go®) 
• 100 mg/20ml solution for infusion in cartridge (APO-go POD®) 

• Apomorphine 10mg lozenges are also approved (RVI) Unlicensed

• Approved for second line use in Parkinson's disease. 

• Ropinirole once daily formulation is only approved for use in Parkinson’s disease patients with proven compliance. 
• Approved for first line use in patients with restless legs syndrome. 

• For use on the advice of specialists in the treatment of Parkinson's disease. Mainly for use in patients who have difficulty with swallowing.
• Approved for second line use in patients with restless legs syndrome.

• 5mg and 10mg tablets

• For use on the advice of neurologists.

• 5mg/5ml Liquid

• Botox also approved for use in paediatric patients with severe bladder over- activity and neuropathic bladder who have not responded to other treatment.
• Prescribe by brand name.

• Prescribe by brand name.

• Restricted to use in private patients receiving aesthetic treatment.
• Prescribe by brand name.

•  50, 100 & 200 unit powder for solution for injection
  • Approved for the treatment of chronic sialorrhoea in line with NICE
  • Similar potency to Botox®, and may be less expensive (depending on price agreements/ contracts), but not licensed for the full range of indications.
  • Prescribe by brand name.

• Prescribe by brand name

• 50mg tablets; 50mg orodispersible tablets (Emylif); 5mg/1ml oral suspension
• Approved for motor neurone disease in line with NICE. 
• Note: use the most cost-effective tolerated formulation. Orodispersible tablets and oral suspension are lower cost formulations, only use plain tablets for when these other options are not suitable.  Orodispersible tablets are not always tolerated due to taste. 
  
  

• For use on the advice of neurologists. 

• Approved for use as last line drug after other alternatives have been considered, in the treatment of congenital and acquired nystagmus.

• COUNTY DURHAM  acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
  • For referral information see https://codurhamrecovery.co.uk/get-support/

• COUNTY DURHAM  acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
  • For referral information see https://codurhamrecovery.co.uk/get-support/

• COUNTY DURHAM  acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
  • For referral information see https://codurhamrecovery.co.uk/get-support/

• Only approved for use in accordance with NICE guidance.
• COUNTY DURHAM  acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
  • For referral information see https://codurhamrecovery.co.uk/get-support/

• The following smoking cessation therapies are approved:
  
  • Nicotine gum -  2mg & 4mg sugar-free chewing gum (Nicorette® is the gum of choice).
  • Nicotine 16 hour patch - 10mg, 15mg, and 25mg/16 hour patches (Nicorette® Invisi). 
  • Nicotine 24 hour patch - 7mg & 14mg, and 21mg /24 hour patches (Nicotinell® is the patch of choice as potential savings to be made).
  • Nicotine lozenges - 2mg and 4mg lozenges (Niquitin® is the lozenge of choice), 1.5mg and 4mg mini lozenges (NiQuitin® Minis Lozenges).
  • Nicotine 2mg sublingual tablets.
  • Nicotine inhalator -  15mg cartridges for use in inhalator.
  • Nicotine oromucosal spray - Nicorette® Quickmist 1mg per dose.
  • Bupropion Hydrochloride 150mg prolonged release tablets
  • Varenicline 0.5mg and 1mg film-coated tablets
  • Cytisinicline (Cytisine) 1.5mg tablets

• Only approved for use in accordance with NICE guidance. 


• In the treatment of substance misuse the 400microgram strength should be prescribed as Subutex® to avoid a product licensed for pain relief being supplied

•  South Tyneside and Sunderland only 

• Methadone 5mg in 5ml oral solution and 5mg in 5ml sugar free solution are both approved for the management of opioid dependence in line with NICE.
•  CD&TV and ST&S

• Approved for the management of opioid dependence in detoxified formerly opioid-dependent people in line with NICE.
• Also approved NoTGhdNC for use in reducing agitation and/ or selfinjurious behaviour in patients with learning disabilities or autism (unlicensed indication). Treatment must be initiated by an appropriate hospital specialist.

• 8mg/0.16ml 16mg/0.32ml, 24mg/0.48ml, 32mg/0.64ml, 64mg/0.18ml, 96mg/0.27ml, 128mg/0.36ml 160mg/0.45ml prolonged-release solution for injection (pre-filled syringes).
  
  • Approved for the treatment of opioid dependance  in adults and adolescents aged 16 years and over, by substance misuse service providers, in line with NTAG and RMOC guidance.
  
  
  

• Only approved for use in accordance with NICE guidance. 
• The oral solution is only approved for limited short-term use in the management of hospital patients who are unable to swallow tablets/ capsules. It is not for use in patients whose dementia is so severe that they can no longer swallow tablets.

• Only approved for use in accordance with NICE guidance. 

• Only approved for use in accordance with NICE guidance. 
• Rivastigmine patches are approved for patients unable to tolerate treatment with oral rivastigmine due to nausea and vomiting, and for patients requiring treatment with an acetylcholinesterase inhibitor who are unable to take oral medication e.g. due to swallowing difficulties or ‘nil by mouth’ prior to surgery.