This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo


Oral formulations containing diazepam.

Drugs List

  • diazepam 10mg tablets
  • diazepam 2mg tablets
  • diazepam 2mg/5ml elixir
  • diazepam 2mg/5ml oral solution sugar-free
  • diazepam 5mg tablets
  • diazepam 5mg/5ml oral suspension
  • Therapeutic Indications


    Acute alcohol withdrawal
    Anxiety state (severe) - short term relief
    Child night terrors and somnambulism
    Control of muscle spasm in tetanus
    Epilepsy (adjunctive treatment)
    Muscle spasms
    Muscular spasm in spastic conditions
    Obsessive-compulsive disorders
    Premedication - sedative



    Severe Anxiety States, obsessive-compulsive neuroses and other psychiatric disorders
    2mg three times a day. Increased if necessary based on individual patient.
    Maximum dose of 30mg a day, in divided doses.

    Insomnia Associated with Severe Anxiety
    5mg to 15mg, to be given at bedtime.

    Cerebral spasticity/palsy
    2mg to 60mg a day, in divided doses.

    Muscle Spasm
    2mg to 15mg a day in divided doses.

    Severe Spasticity (e.g. Cerebral Spasticity, Upper Motor Neurone Disease)
    5mg to 60mg a day, in divided doses.

    Muscle Spasm in Tetanus
    3mg/kg to 10mg/kg of bodyweight a day.

    Some reference sources indicate this dose by nasoduodenal tube using a suitable liquid oral dose form.

    Adjunctive treatment of seizures
    2mg to 60 mg a day, in divided doses.

    Alcohol Withdrawal Symptoms
    5mg to 20mg. Dose may be repeated after 2 to 4 hours, if considered necessary.

    5mg to 20mg, based on individual patient, 1 to 2 hours before procedure.

    Premedication in dental patients
    5mg administered the night before. Another 5mg on waking. Followed by another 5mg 2 hours before appointment.


    It is recommended to administer half the usual adult dose in elderly and/or debilitated patients.


    Night Terrors and Somnambulism
    1mg to 5mg to be given at bedtime.

    2mg to 10mg

    Cerebral spasticity/palsy
    2mg to 40mg a day, given in divided doses.

    The following dosing schedule may also be suitable:
    Children aged 12 to 18 years
    10mg twice a day.
    Maximum daily dose of 40mg.
    Children aged 5 to 12 years
    5mg twice a day.
    Children aged 1 to 5 years
    2.5mg twice a day.
    Children aged 1 month to 1 year
    250micrograms/kg twice a day.

    Muscle spasm in tetanus
    The following dosing schedule may be suitable:
    3mg/kg of bodyweight to be given over 24 hours, adjusted based on individual patient response.
    Some reference sources indicate this dose by nasoduodenal tube using a suitable liquid oral dose form.

    Patients with Renal Impairment

    Reduce dose in patients with renal impairment due to cerebral sensitivity.

    The Renal Drug Handbook suggests for Glomerular filtration rate (GFR)
    20ml/minute to 50ml/minute: Dose as normal.
    Below 20ml/minute: Reduce dose, titrating based on individual patient response.


    For oral administration

    Nasoduodenal tube (Muscle spasm in tetanus)

    Shake syrup well before use.


    Acute respiratory impairment
    Chronic psychosis
    Myasthenia gravis
    Respiratory depression
    Severe hepatic impairment
    Severe respiratory impairment
    Sleep apnoea

    Precautions and Warnings

    Children under 18 years
    Suicidal ideation
    Cardiorespiratory insufficiency
    Cerebral arteriosclerosis
    Chronic respiratory impairment
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of alcohol abuse
    History of drug misuse
    Lactose intolerance
    Muscle weakness
    Organic brain syndrome
    Personality disorder
    Renal impairment

    May exacerbate myasthenia gravis
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine is subject to driving restrictions
    Not suitable as sole treatment of depression or anxiety with depression
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Some formulations contain sucrose
    Monitor patients with a history of alcoholism and drug abuse
    Monitor patients with marked personality disorders
    Reassess need for continued treatment at regular intervals
    Refer women considering pregnancy for specialist advice and monitoring
    Tolerance and dependence may occur
    Amnesia may occur
    Discontinue if psychiatric disturbances develop
    Potential for withdrawal symptoms
    Psychological adjustment may be impaired in loss or bereavement
    Withdraw gradually after long-term use
    Discontinue if paradoxical reactions occur
    Limit prescribing quantity due to suicide risk
    Reduce dose in debilitated patients
    Reduce dose in elderly
    Not recommended for use longer than 4 weeks
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Advise patient grapefruit products may increase plasma level
    Advise patient on possible rebound phenomena on withdrawal

    The lowest dose and shortest duration possible should be used.

    There is a risk of both physical and psychic dependence to diazepam which increases with dose and duration. A maximum of 2 to 4 weeks treatment is recommended (including tapering off period) due to the risk of dependence.

    The efficacy to the hypnotic effects of diazepam may lessen after repeated use for a few weeks.

    It may be useful to specifically discuss the short term nature of the treatment, how it will be tapered off and how rebound phenomenon may occur to minimise the anxiety this may provoke.

    Diazepam is considered unsuitable for the short term management of mild anxiety

    Elderly and debilitated patients may be more prone to adverse effects such as sedation, drowsiness and confusion and so lower dosages should be used. However, if these symptoms occur in any patient , which might be expected to be more likely during the first week of treatment or with high doses, it may be suitable for half the total daily dose to be given at night with the remaining dose given in divided doses during the day.

    Use with caution in patients with organic brain disease, particularly arteriosclerosis as the limits of tolerance may be very wide in this patient group and dosage adjustment should be considered.

    Diazepam may induce anterograde amnesia which occurs most frequently several hours after a dose. To reduce the risk patients should ideally ensure they can have uninterrupted sleep for 7 to 8 hours after a dose.

    Use with caution in patients with cardiorespiratory insufficiency, as the limits of tolerance may be very wide in this patient group and dosage adjustment should be considered.

    Chronic mild to moderate pulmonary insufficiency - reduce dose

    Pregnancy and Lactation


    Use diazepam with caution in pregnancy.

    Women of child bearing potential should be advised to discuss withdrawal of diazepam if they should wish to become, or discover they are, pregnant.

    There may be a small increased risk of congenital malformation (such as oral cleft) if benzodiazepines are used during the first trimester of pregnancy.

    If, for compelling reasons, diazepam is administered during the late phase of pregnancy or during labour at high doses, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression can be expected due to the pharmacological action of the drug.

    Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Diazepam is contraindicated in breastfeeding.

    Benzodiazepines are found in breast milk and so should not be used by breast feeding mothers.

    Reports have shown milk plasma concentration ratios vary. Therefore there is a risk of accumulation in the breastfeeding child. LactMed suggest in a single dose of diazepam in sedation before a procedure, there would be no need to wait before the patient resumes breastfeeding unless it was a newborn or preterm infant where caution is advised and a wait of 6 to 8 hours before the mother resumes breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving. When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them. It is an offence to drive while under the influence of this medicine. However, a patient is not committing an offence (called 'statutory defence') if: 1.The medicine has been prescribed to treat a medical or dental problem and 2.The medicine has been taken according to the instructions given by the prescriber and/or in the information provided with the medicine and 3.The medicine was not affecting the ability to drive safely. For further guidance see

    Side Effects

    Aggressive reaction
    Allergic skin reactions
    Anterograde amnesia
    Behavioural disturbances
    Blood dyscrasias
    Blurred vision
    Cardiac arrest
    Cardiac failure
    Changes in libido
    Decreased appetite
    Depression (with risk of suicide)
    Epileptic seizures
    Gastric upset
    Hypersensitivity reactions including anaphylaxis
    Impaired co-ordination
    Impaired concentration
    Increase in alkaline phosphatase
    Increase in serum ALT/AST
    Increase in serum transaminases
    Increased appetite
    Increased bronchial secretions
    Loss of balance
    Muscle spasm
    Muscle weakness
    Numbed emotions
    Panic attack
    Paranoid delusions
    Respiratory arrest
    Respiratory depression
    Salivation changes
    Sensory disturbances
    Slurred speech
    Unsteady gait
    Urinary retention
    Visual disturbances
    Withdrawal symptoms

    Withdrawal Symptoms and Signs

    Abrupt withdrawal of diazepam may result in symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood changes. In severe cases the following may occur: a feeling of unreality or of being separated from the body, depersonalisation, confusional states, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures.

    Withdrawal symptoms will be worse in patients with epilepsy, patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Signs and Symptoms

    Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually lasts only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic respiratory disease.

    Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.


    Consider activated charcoal in adults or children who have taken more than 1 mg/kg within 1 hour, provided they are not too drowsy. Gastric lavage is unnecessary if these drugs have been taken alone. Patients who are asymptomatic at four hours are unlikely to develop symptoms. Institute supportive measures as indicated by the patient's clinical state.

    If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should rarely be required. It has a short half-life (about an hour) and should NOT TO BE USED IN MIXED OVERDOSE OR AS A "DIAGNOSTIC" TEST. It is contraindicated in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants).

    Further Information

    Last Full Review Date: May 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.

    Summary of Product Characteristics: Diazepam Tablets 2mg. Actavis. Revised December 2014.
    Summary of Product Characteristics: Diazepam Tablets 5mg. Actavis. Revised December 2014.
    Summary of Product Characteristics: Diazepam Tablets 10mg. Actavis. Revised December 2014.
    Summary of Product Characteristics: Diazepam Oral solution 2mg/5ml sugar free. Accord. Revised August 2018.
    Summary of Product Characteristics: Diazepam 2mg/5ml oral suspension. Sandoz Ltd. Revised September 2018.
    Summary of Product Characteristics: Diazepam Forte Syrup 5mg/5ml. Sandoz. Revised July 2005.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    MHRA 22nd January 2007
    Available at:
    Last accessed: 19 May 2016

    NICE - Evidence Services
    Available at:
    Last accessed: 27 June 2017.

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    Last revised: 21 March 2013
    Last accessed: 19 May 2016

    The Welsh Medicines Information Centre (WMIC) - Porphyria Information Service.
    Available at:
    Last revised: 01 May 2016
    Last accessed: 19 May 2016

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Diazepam Last revised: 07 September 2013
    Last accessed: 19 May 2016 Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: Last accessed: 6 January 2015

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.