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


Oral formulations containing sulpiride

Drugs List

  • sulpiride 200mg tablets
  • sulpiride 200mg/5ml oral solution sugar-free
  • sulpiride 400mg tablets
  • Therapeutic Indications


    Schizophrenia (acute+chronic) predominantly with negative symptoms
    Schizophrenia (acute+chronic) predominantly with positive symptoms

    Unlicensed Uses

    Gilles de la Tourette syndrome



    Initial dose: 400mg to 800mg daily, given in two divided doses (morning and early evening).

    Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce any further improvement.

    Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800mg daily; therefore a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of sulpiride.

    Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400mg to 600mg twice daily.


    (See Dosage; Adult)
    Elderly patients are usually more sensitive to centrally-acting drugs, therefore a lower starting dose is recommended, increasing gradually to the normal adult dose according to response.


    Sulpiride is not licensed in children under 14 years.

    Children aged 14 to 18 years
    Initial dose: 200mg to 400mg, twice daily.
    In predominantly positive symptoms, the dose may be increased to a maximum of 2.4g daily if necessary.
    In predominantly negative symptoms, the dose may be increased to a maximum of 800mg if necessary.

    Gilles de la Tourette syndrome (unlicensed)
    Children aged 12 to 18 years
    100mg to 400mg, given twice daily.
    Children aged 2 to 12 years
    50mg to 400mg, given twice daily.

    Patients with Renal Impairment

    Some manufacturers contraindicate sulpiride in severe renal impairment.

    The Renal Drug Handbook states that sulpiride may be used throughout all stages of renal impairment if the following dosage adjustments are used:

    Patients with GFR between 20ml/minute and 50ml/minute: The dose should be reduced to 66% of the normal dose or the dosage interval increased by a factor of 1.5.

    Patients with GFR between 10ml/minute and 20ml/minute: The dose should be 50% of the normal dose, or the dosing interval should be multiplied by 2.

    Patients with GFR below 10ml/minute: The dose should be lowered to 30% of the normal dose, alternatively the dosing interval may be increased by a factor of 3.


    Acute alcohol intoxication
    Children under 2 years
    Bone marrow aplasia
    Breast neoplasm
    Central nervous system depression
    Long QT syndrome
    Pituitary neoplasm
    Prolactin-dependent neoplasm
    Torsade de pointes

    Precautions and Warnings

    Children aged 2 to 14 years
    Extrapyramidal disturbances
    Family history of breast cancer
    Family history of long QT syndrome
    Family history of narrow angle glaucoma
    Predisposition to venous thromboembolism
    Risk of cerebrovascular accident
    Benign prostatic hyperplasia
    Cardiovascular disorder
    Electrolyte imbalance
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    Hereditary fructose intolerance
    History of cerebrovascular disorder
    History of jaundice
    History of seizures
    History of torsade de pointes
    Lactose intolerance
    Myasthenia gravis
    Narrow angle glaucoma
    Parkinson's disease
    Predominant excitation or agitation
    Renal impairment
    Severe respiratory disease

    Correct electrolyte disorders before treatment
    Reduce dose in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    May reduce seizure threshold
    Patients at risk of arrhythmias perform ECG prior to initiating therapy
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Perform ECG before and during treatment
    Monitor closely patient with strong family history of breast cancer
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Monitor patients with epilepsy while taking this treatment
    Monitor serum electrolytes
    Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
    Perform blood counts if unexplained infection or fever develops
    Risk of cerebrovascular events
    May cause convulsions
    May cause or exacerbate extrapyramidal symptoms
    May cause postural hypotension especially in elderly
    Potential for withdrawal symptoms
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Reduce dose +/or add antiparkinsonian drug if extrapyramidal symptoms occur
    Avoid abrupt withdrawal
    Discontinue if patient develops neuroleptic malignant syndrome
    Advise patient to avoid alcohol during treatment
    Advise patient that photosensitivity possible

    Data from observational studies showed a small increased risk of death in elderly patients with dementia when treated with antipsychotics. A 3 fold increase in the risk of cerebrovascular events has been observed in patients with dementia treated with atypical antipsychotic drugs. Sulpiride should therefore be used with caution in patients with risk factors for stroke.

    Increased motor agitation has been reported at high dosage in a small number of patients: in aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms. Sulpiride may be given with a sedative in patients with aggressive behaviour or agitation with impulsiveness. Care should be exercised where mania or hypomania is present.

    Pregnancy and Lactation


    Use sulpiride with caution in pregnancy

    The manufacturers recommend that sulpiride should not be taken during pregnancy.

    Use in the third trimester of pregnancy may result in extrapyramidal effects, lethargy and hypotonia in the neonate.

    Schaefer and co-workers remark that pregnancy alone is not a justification for stopping treatment and that the benefits of maintaining therapy may well outweigh the risks, particularly for patients stabilised on benzamide antipsychotics. Similarly, for the authors the intentional, or inadvertent use of sulpiride during pregnancy does not warrant termination. Rather, detailed foetal ultrasonography (after its use in the first trimester) and regular obstetric care should be offered in order to allow for the timely diagnosis of possible complications.

    When neuroleptics have been used up to delivery, observation of the neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers are advised to reduce the dose or even interrupt treatment in the days immediately preceding delivery.

    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 ( ).


    Sulpiride is contraindicated in breastfeeding.

    Sulpiride is excreted into breast milk and breastfeeding is not recommended during treatment. No side-effects had been observed in nursing infants whose mothers were taking sulpiride.

    NICE advises that Infants of mothers who are breastfeeding while taking psychotropic medication should be monitored for adverse reactions.

    As a dopamine antagonist, sulpiride may increase prolactin levels and thus lead to increased production of breast milk.

    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

    Side Effects

    Blurred vision
    Breast enlargement
    Breast pain
    Cardiac arrest
    Changes in libido
    Contact sensitisation
    Corneal opacities
    Deep vein thrombosis (DVT)
    Difficulty in micturition
    Dry mouth
    ECG changes
    Erectile dysfunction
    Exfoliative dermatitis
    Extrapyramidal effects
    Haemolytic anaemia
    Hypersensitivity reactions
    Increases in hepatic enzymes
    Lens opacities
    Maculopapular rash
    Nasal congestion
    Neuroleptic malignant syndrome
    Oculogyric crisis
    Orgasmic dysfunction
    Postural hypotension
    Prolongation of QT interval
    Pulmonary embolism
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Sexual disturbances
    Skin reactions
    Sleep disturbances
    Sudden death reported
    Tardive dyskinesia
    Thrombocytopenic purpura
    Torsades de pointes
    Venous thrombosis
    Ventricular arrhythmias
    Ventricular fibrillation
    Ventricular tachycardia
    Weight gain


    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: November 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Handbook on Injectable Drugs, 15th Edition, Trissel, L. American Society of Health-System Pharmacists.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Dolmatil Tablets. Sanofi-Aventis. Revised July 2016
    Summary of Product Characteristics: Sulpor 200mg/5ml oral solution. Rosemont Pharmaceuticals Ltd. Revised March 2010
    Summary of Product Characteristics: Sulpiride 200mg/5ml oral solution. Rosemont Pharmaceuticals Ltd. Revised February 2016
    Summary of Product Characteristics: Sulpiride Tablets 200mg, 400mg. Wockhardt UK Ltd. Revised January 2010

    NICE Evidence Services Available at: Last accessed: 04 September 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Sulpiride Last revised: 07 September 2016
    Last accessed: 14 November 2016

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    Last revised: 10 June 2010
    Last accessed: 14 November 2016

    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.