Atypical (Second-generation) Antipsychotic — Benzamide Pregnancy: §4.6: only limited data are available in pregnant women and safety in human pregnancy has not been established; amisulpride crosses the placenta and animal studies have shown reproductive toxicity. 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 to antipsychotics during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms varying in severity and duration after delivery (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder) — newborns should be monitored carefully. Breastfeeding: amisulpride is excreted into breastmilk in rather large amounts (above 10% of the maternal weight-adjusted dosage in some cases) but infant blood concentrations have not been evaluated and information on effects in newborns/infants is insufficient — decide whether to discontinue breast-feeding or amisulpride therapy taking account of the benefit of each. Fertility: a decrease in fertility related to the prolactin-dependent pharmacological effect was observed in treated animals.

Amisulpride

Brand names: Solian

Amisulpride is an atypical antipsychotic of the substituted benzamide class used in the treatment of schizophrenia, including presentations with predominantly positive or predominantly negative symptoms.

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: Acute psychotic episodes: 400 mg/day to 800 mg/day

Route: Oral

Frequency: Once daily at doses up to 400 mg; higher doses should be split into two separate doses

Max: In individual cases the daily dose may be increased up to 1200 mg/day. Doses above 1200 mg/day have not been extensively evaluated for safety and therefore should not be used.

Source: UK SPC (eMC) for Amisulpride 100 mg Tablets, §4.2 (https://www.medicines.org.uk/emc/product/102319/smpc). ACUTE PSYCHOTIC EPISODES: oral doses between 400 mg/day and 800 mg/day are recommended; in individual cases the daily dose may be increased up to 1200 mg/day; doses above 1200 mg/day should not be used. No specific titration is required when initiating treatment. Doses should be adjusted according to individual response; for patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. PREDOMINANT NEGATIVE SYMPTOMS: oral doses between 50 mg/day and 300 mg/day are recommended, adjusted individually. ADMINISTRATION SPLIT: amisulpride can be administered once daily at oral doses up to 400 mg; higher doses should be split into two separate doses. The minimum effective dose should be used. ELDERLY: safety has been examined in only a limited number of elderly patients — use with particular caution because of a possible risk of hypotension and sedation; a reduction in dosage may also be required because of renal insufficiency. HEPATIC INSUFFICIENCY: since the drug is weakly metabolised, a dosage reduction should not be necessary. PAEDIATRIC (not expressed as a per-kg dose in the SPC): efficacy and safety from puberty to the age of 18 years have not been established and there are limited data in adolescents with schizophrenia, so use from puberty to 18 years is NOT recommended; in children up to puberty amisulpride is CONTRAINDICATED as its safety has not been established. Verify any under-18 use against a children's formulary. QT PROLONGATION (§4.4): caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or a family history of QT prolongation, and concomitant use with neuroleptics should be avoided. METHOD OF ADMINISTRATION: for oral use. §4.5 Interactions was not retrieved in full in this bundle — the interactions listed below are taken from the §4.3 Contraindications and §4.4 Warnings text; verify the full §4.5.

Dose adjustments

Renal

Amisulpride is eliminated by the renal route. Reduce the dose to HALF in patients with creatinine clearance 30-60 ml/min and to a THIRD in patients with creatinine clearance 10-30 ml/min. There is no experience in patients with severe renal impairment (creatinine clearance <10 ml/min) — particular care is recommended in these patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer)
Phaeochromocytoma
Children up to puberty
Combination with levodopa

Side effects

Very common: extrapyramidal symptoms (tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia) — generally mild at optimal dosages, dose related, and very low with 50-300 mg/day for predominantly negative symptoms; common acute dystonia (spasm torticollis, oculogyric crisis, trismus) and somnolence; uncommon tardive dyskinesia and seizures; rare neuroleptic malignant syndrome
Common: increase in plasma prolactin levels (reversible after discontinuation) which may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain and erectile dysfunction
Common: insomnia, anxiety, agitation, orgasmic dysfunction; uncommon confusion
Common: constipation, nausea, vomiting, dry mouth; common blurred vision
Common: hypotension; uncommon bradycardia and increase in blood pressure; rare QT interval prolongation, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest and sudden death; rare venous thromboembolism including fatal pulmonary embolism and deep vein thrombosis

Interactions

Levodopa — combination is contraindicated
Other neuroleptics — concomitant use should be avoided because of the risk of QT prolongation; caution in patients with known cardiovascular disease or a family history of QT prolongation
Other antipsychotics and CNS depressants — uncommon aspiration pneumonia has been reported mainly in association with these

Clinical monograph

How it works

It is a selective antagonist at dopamine D2 and D3 receptors. At lower doses it preferentially blocks presynaptic autoreceptors, while at higher doses postsynaptic blockade predominates, which is reflected in its dose-related clinical and adverse effects.

Prescribing in practice

It causes dose-dependent prolongation of the QT interval; assess cardiac risk factors, avoid co-prescribing with other QT-prolonging drugs where possible, and consult the SPC on ECG monitoring.
It is largely excreted unchanged by the kidneys, so the dose must be reduced in renal impairment to avoid accumulation.
It commonly causes marked hyperprolactinaemia, and extrapyramidal effects become more prominent at higher doses.

Monitoring

Monitor renal function and adjust dosing accordingly, and obtain ECGs to assess QT interval, particularly with cardiac risk factors. Review for symptoms of raised prolactin (such as galactorrhoea, menstrual disturbance or sexual dysfunction) and for extrapyramidal effects, alongside standard antipsychotic metabolic monitoring.

Counselling the patient

Report a fast, slow or irregular heartbeat, fainting or palpitations promptly.
Tell your prescriber about breast tenderness or discharge, changes in periods, or sexual problems, which can be caused by this medicine.
Report any uncontrolled movements, tremor or muscle stiffness.

Evidence & guidelines

An established second-generation antipsychotic recommended within UK guidance (NICE) for schizophrenia, with QT prolongation a recognised dose-dependent class concern.

Reference: NICE CG178 (Psychosis and Schizophrenia); 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways