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First-generation antipsychotic (substituted benzamide) Pregnancy: §4.6 — Only very limited data in pregnant women; safety in human pregnancy has not been established and sulpiride crosses the placenta. Use is not recommended during pregnancy, or in women of childbearing potential not using effective contraception, unless the benefits justify the potential risks. Neonates exposed during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms — monitor newborns carefully. Breast-feeding: excreted into breastmilk in rather large amounts; decide whether to discontinue breast-feeding or sulpiride therapy.

Sulpiride

Brand names: Dolmatil, Sulpor

Sulpiride is a substituted benzamide first-generation antipsychotic used in schizophrenia, with predominantly negative symptoms sometimes targeted at lower doses.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Starting dose 400 mg to 800 mg daily, given as one or two 200 mg tablets twice daily (morning and early evening)
Route: Oral
Frequency: Twice daily (morning and early evening)
Max: Suggested maximum of 1200 mg twice daily (stated for predominantly positive symptoms); increasing the dose beyond this level has not been shown to produce further improvement
Source: UK SPC (eMC) for Sulpiride 200 mg Tablets, §4.2 (https://www.medicines.org.uk/emc/product/2430/smpc). SYMPTOM-DIRECTED DOSING (§4.2): predominantly POSITIVE symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses — a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg twice daily. Predominantly NEGATIVE symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) respond to doses below 800 mg daily — a starting dose of 400 mg twice daily is recommended; reducing this dose towards 200 mg twice daily will normally increase the alerting effect of sulpiride. MIXED positive and negative symptoms with neither predominating: normally respond to 400 mg-600 mg twice daily. ELDERLY: the same dose ranges are applicable, but the dose should be reduced if there is evidence of renal impairment; elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects. PAEDIATRIC: §4.2 states 'Clinical experience in children under 14 years of age is insufficient to permit specific recommendations'; §4.4 states efficacy and safety in children have not been thoroughly investigated and caution should be exercised when prescribing to children — no per-kg paediatric dose is given in the source. Verify any under-18 use against a children's formulary. WITHDRAWAL (§4.4): gradual withdrawal is advisable. §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved as a separate section — the interaction below is taken from the §4.3 contraindication text.

Dose adjustments

Renal

§4.2 states only that in the elderly the same dose ranges apply 'but the dose should be reduced if there is evidence of renal impairment'. No creatinine-clearance-banded regimen is stated in the retrieved sections.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Phaeochromocytoma and acute porphyria
  • Hypersensitivity to sulpiride or to any of the excipients
  • Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer
  • Association with levodopa or antiparkinsonian drugs (including ropinirole)

Side effects

  • Nervous system (common): sedation or drowsiness, extrapyramidal disorder, Parkinsonism, tremor, akathisia; uncommon hypertonia, dyskinesia, dystonia; not known — neuroleptic malignant syndrome, tardive dyskinesia, convulsion
  • Endocrine/reproductive (common): hyperprolactinaemia, breast pain, galactorrhoea; uncommon breast enlargement, amenorrhoea, abnormal orgasm, erectile dysfunction; not known gynaecomastia
  • Cardiac (rare): ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia; not known — QT prolongation, cardiac arrest, torsade de pointes, sudden death
  • Vascular (uncommon): orthostatic hypotension; not known — venous embolism, pulmonary embolism, deep vein thrombosis
  • Blood (uncommon): leukopenia; not known — neutropenia, agranulocytosis
  • Other common: insomnia, constipation, hepatic enzyme increased, maculo-papular rash, weight gain

Interactions

  • Levodopa or antiparkinsonian drugs (including ropinirole) — concomitant use is contraindicated (§4.3, cross-referencing §4.5). The full §4.5 section was not retrieved in this bundle and must be checked separately.

Clinical monograph

How it works

It is a selective antagonist of dopamine D2 and D3 receptors, with relatively little activity at other receptor types.

Prescribing in practice

  • It can prolong the QT interval and cause hyperprolactinaemia, with effects such as galactorrhoea, menstrual disturbance and sexual dysfunction.
  • It is largely renally excreted, so reduced doses and caution are needed in renal impairment.
  • Extrapyramidal effects and neuroleptic malignant syndrome can occur, as with other antipsychotics.

Monitoring

Monitor for extrapyramidal symptoms, prolactin-related effects, renal function and QT interval where cardiac risk factors exist.

Counselling the patient

  • Report any breast swelling or discharge, menstrual changes or sexual difficulties to your doctor.
  • Tell your doctor if you develop muscle stiffness, tremor or restlessness.
  • Do not stop the medicine suddenly without advice.

Evidence & guidelines

Sulpiride is an established antipsychotic, and its use is informed by NICE guidance on the management of psychosis and schizophrenia.

Reference: NICE CG178; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.