• First line: melatonin 1mg and 5mg modified release tablets in line with licensed indications only. 


• Second line: melatonin 2mg modified release tablets.


• Third line: melatonin 2mg modified release tablets (crushed)


• Fourth 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. 
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 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. 
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 by the NoT APC therefore subject to formal shared care guidance.  Please follow link below for the most recent guideline

• To be used in accordance with NICE criteria

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

• Approved for the treatment of narcolepsy with cataplexy in children only in accordance with NHS england clinical commissioning policy.
• Must be prescribed by Dr Kirstie Anderson (specialist sleep service at NUTH).
• The Northern (NHS) Treatment Advisory Group only 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 use of sodium oxybate in new adult patients is not recommended.

• For use in palliative care.
• Note: Methotrimeprazine 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 NTW Pharmacy for continued supply on admission and discharge

• 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.

• 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.
    
    
  
  

• NTAG approved for the treatment of schizophrenia as per its licensed indication and as outlined in the Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.

• Fluphenazine is to be discontinued in late 2018
  
  
  
  • All patients currently prescribed fluphenazine decanoate should have a medication review
  
  
  
  

• NTAG approved for the treatment of schizophrenia as per its licensed indication and as outlined in the Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.

• 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)

• 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)

• 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. After a minimum of 12 weeks, prescribing may be transferred to primary care. 

• 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. 
• Patients who are deemed stable on doses of up to 225mg daily of MR venlafaxine should be switched to the equivalent dose of immediate release venlafaxine.
• MR tablets are only to be used in patients currently prescribed doses of 300mg and over and for whom there is no suitable alternative, those who have experienced discontinuation reactions (at any dose), and for patients who need to take the once daily formulation in order to facilitate care visits.

• Only approved for use in accordance with NICE guidance. 

• Please prescribe by brand name


• Approved for ADHD and the treatment of narcolepsy in adult and paediatrics.


• 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
  
  
  
  

• 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

• Only approved for limited use in the treatment of patients with narcolepsy.

• 75mg and 150mg tablets
  
  
  
  • approved for the treatment of narcolepsy with or without cataplexy in adults as an alternative to pitolisant in those who would have otherwise received pitolisant in line with NTAG guidance
  
  
  
  

• 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. 

• Levomepromazine 6mg tablets unlicensed.
• Levomepromazine 25mg in 1ml injection is approved for use in palliative care. 

• 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

• 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.

•  1mg/5mL oral solution sugar free
• Approved for the first line treatment of uncontrolled oral/respiratory secretions/sialorrhoea in Motor Neurone Disease/Home Ventilation patients who have cognitive impairment.
• Approved for second line treatment of uncontrolled oral/respiratory secretions/sialorrhoea in Motor Neurone Disease/Home Ventilation  patients who have failed other treatment options such as hyoscine patches or who have intolerance to other agents.


• 2mg/5ml oral solution (Sialanar®)
  
  • approved for the treatment of severe sialorrhoea in children and adolescents with chronic neurological disorders.
  
  

• 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.
  
  

• 15mg and 30mg tablets


• The following codeine preparations are unlicensed and approved for use:
  
  
  
  
  • codeine 30mg in 1ml injection 
  
  
  • codeine 2mg, 3mg, 6mg, 15mg;
  
  
  • 30 mg suppositories.
  
  
  
  

• Zomorph is the preferred formulation. 
• Morphine 20mg, 30mg, 60mg, 100mg & 200mg sachets of MR granules for preparing oral  suspensions are only approved for use when other formulations are unsuitable. 
• Note: the following unlicensed preparations are also approved for use:
  
  • morphine 5mg in 1ml injection;
  • 10mg in 1ml preservative free injection;
  • 2mg in 5ml epidural
  • 50mg in 50ml PCA injection. 
  
  

•  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 diamorhine   

• 15microgram sublingual tablets
• Approved only for Gateshead Health NHS Foundation Trust whose patients have had total knee replacement and are part of an enhanced recovery programme.

• 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. 

• 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.
• To be initiated by a specialist

• Fentanyl 200 microgram lozenges with oromucosal applicator
  
  
  
  • approved for limited short-term use in RVI burns unit .
  
  
  • treatment of very severe incident pain on the advice of palliative care specialists .
  
  
  • treatment of very severe incident pain on the advice of pain specialists . 
  
  
  
  


• Fentanyl sublingual tablets (Abstral®) are also approved but only for patients experiencing incident pain during radiotherapy, restricted to palliative care use only .


• 12, 25, 50, 75 & 100 microgram/hour transdermal patches (First choice brand - Mezolar®) .
  
  
  
  • Mezolar® has replaced Matrifen® as the first choice brand. Patients who currently use Matrifen® can continue to do so if managing well.
  
  
  
  

• The following preparations are approved:
  
  • 5mg tablets;
  • 2mg in 5ml linctus;
  • 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 Longtec® 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 breast feeding mothers immediately postdelivery/ c-section where adequate pain relief has not been achieved using paracetamol and NSAIDs. Patients requiring contunation of dihydrocodeine following discharge (post delivery/c-section) can have dihydrocodeine prescribed in primary care (for short-term use only).

• 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.

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

• 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.

• For use in the treatment of neuropathic pain. ECG monitoring is required to be carried out by pain clinic consultants as part of the initiation process of mexiletine, as patients are required for cardiac arrhythmias.

• 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 

• 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.

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

• 225mg/1.5ml solution for injection (Pre-filled pens/syringes)
  
  
  
  • Approved for the prevention of chronic migraine in adults.
  
  
  
  

• 120mg/1ml injection
  
  
  
  • Approved for the prevention of migraines in adults 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.

• 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.

• 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 

• 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.

• 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.

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

• 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. 

• Only approved for use in accordance with NICE guidance. 

• 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.

• 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.

• Buccolam® 5mg/ml alcohol-free buccal solution, and Buccolam® 2.5mg, 5mg, 7.5mg and 10mg prefilled oral syringes are approved as first choice for status epilepticus in children aged 3 months to 18 years. 
  
  
• Epistatus® 10mg in 1ml oromucosal solution pre-filled oral syringes is approved for use in the treatment of epileptic seizures in infants under 3 months and adults over 18 years of age. This use is off-label
  Injection solutions (section 15.1.4) can also be given buccally
  
  
• Midazolam 2.5mg in 5ml oral solution is approved for use as a sedative. To be used in preference to administering the injection orally (more cost effective).unlicensed

• 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.

• 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.

• 30mg/3ml injection


• 30mg/3ml injection


• 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.

• Approved as an alternative to tolcapone in patients with Parkinson's disease in whom entacapone has not been tolerated or failed.

• 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.

• 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.

• Restricted to use in private patients receiving aesthetic treatment. 


• Prescribe by brand name.

• Prescribe by brand name

• Approved for motor neurone disease in line with NICE. 
• Note: riluzole oral suspension approved only when other preparations (including crushing tablets) are not suitable.

• 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.

• Only approved for use in accordance with NICE guidance. 

• The following nicotine replacement treatments 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.
  
  
  
  

• Only approved for use in accordance with NICE guidance. 

• 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

• 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.

• Approved for the management of opioid dependence in detoxified formerly opioid-dependent people in line with NICE.
• Also approved 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 and GPs should only be asked to prescribe it for responders in accordance with a shared care guideline

• 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.

• Approved for intrathecal neurolysis treatment of intractable pain due to cancer in terminally ill patients

• Approved as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis in line with NICE

• 10mg vial 


• Approved for the treatment of hereditary transthyretin amyloidosis in adults with stage 1 and stage 2 polyneuopathy in line with NICE

• Approved for intrathecal neurolysis treatment of intractable pain due to cancer in terminally ill patients