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Clomethiazole oral capsules


Oral capsules containing clomethiazole.

Drugs List

  • clomethiazole 192mg capsules
  • Therapeutic Indications


    Acute alcohol withdrawal
    Restlessness/agitation in the elderly
    Severe insomnia (short-term treatment)



    Alcohol withdrawal states
    Alcohol withdrawal should be treated in hospital, or in exceptional circumstances, on an outpatient basis by specialist units when the daily dose must be closely monitored by community health staff. Dosage should be adjusted to patient response. The patient should be sedated but rousable. A suggested dosage regimen is:
    Initial dose: 2 to 4 capsules, repeated if necessary after some hours
    Day 1: 9 to 12 capsules divided into 3 or 4 doses
    Day 2: 6 to 8 capsules divided into 3 or 4 doses
    Day 3: 4 to 6 capsules divided into 3 or 4 doses
    Days 4 to 6: A gradual reduction until the final dose
    Administration for more than 9 days is not recommended.


    Restlessness and agitation in the elderly
    One capsule three times daily.

    Severe insomnia in the elderly
    1 to 2 capsules before going to bed. The lower dose should be tried first. Treatment should be kept to a minimum, reviewed regularly, and discontinued as soon as possible.

    Elderly patients should be treated with caution as there may be increased bioavailability and delayed elimination of clomethiazole.

    Patients with Hepatic Impairment

    Dosage may need to be reduced due to increased systemic availability and delayed elimination of the drug. Care should be taken as sedation may mask the onset of hepatic coma.


    Children under 18 years
    Acute respiratory impairment
    Hereditary fructose intolerance

    Precautions and Warnings

    Cardiac disorder
    Chronic hepatic disorder
    Chronic renal disorder
    Hepatic cirrhosis
    History of drug misuse
    Personality disorder
    Respiratory impairment
    Sleep apnoea

    Advise ability to drive/operate machinery may be affected by side effects
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Monitor patients with hepatic impairment for toxic effects
    Prolonged or excessive use may result in dependence
    Avoid prolonged use
    Advise patient that the effects of alcohol may be potentiated
    Advise patients to seek medical advice if confusion occurs

    Hepatic impairment - Moderate liver disorders associated with alcoholism do not preclude the use of clomethiazole, though an associated increase in systemic availability of oral doses and delayed elimination of the drug may require reduced dosage. Great caution should be observed in patients with gross liver damage and decreased liver function, particularly as sedation can mask the onset of liver coma.

    Cardiac and/or respiratory disease - confusional state may indicate hypoxia. Recognition and specific treatment of the cause is essential in these patients, and in such cases sedatives/hypnotics should be avoided.

    Due to the risk of respiratory depression in patients with cirrhosis, alcoholics must not be prescribed clomethiazole if they continue to drink alcoholic beverages.

    Pregnancy and Lactation


    Clomethiazole is contraindicated during pregnancy.

    Use of clomethiazole during pregnancy is contraindicated by the manufacturer.

    At the time of writing there is limited published information regarding the use of clomethiazole during pregnancy. Potential risks are unknown.


    Use clomethiazole with caution during breastfeeding.

    The manufacturer notes that clomethiazole should only be considered if the benefit outweighs the potential risk. Available data indicates clomethiazole is expressed in human breast milk, but the quantity is unknown. Effects on exposed infants are unknown.

    Side Effects

    Bullous eruption
    Conjunctival irritation
    Excitement (paradoxical)
    Gastro-intestinal disturbances
    Hangover effects
    Increased bronchial secretions
    Increased nasopharyngeal secretions
    Increases in serum transaminases (transient)
    Nasal congestion
    Nasal irritation
    Serum bilirubin increased
    Withdrawal symptoms


    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 ( ).

    Further Information

    Last full review date: May 2013

    Reference Sources

    Summary of Product Characteristics: Clomethiazole capsules. Intrapharm Laboratories Ltd. Revised March 2011.

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

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    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.