Atypical antipsychotic of the benzamide class
ATC code: N05AL05 (Amisulpride)
Brand names
Solian
Selective antagonist of D2/D3 dopamine receptors. Distinct feature: at low doses (50–300 mg/day) it preferentially blocks presynaptic D2/D3 autoreceptors and exerts an «activating» effect, reducing negative schizophrenia symptoms. At high doses (400–1200 mg/day) it blocks postsynaptic receptors and addresses positive symptoms. No serotonergic, histaminergic or adrenergic activity, so metabolic and sedation profiles are better than with olanzapine.
Second line
Atypical antipsychotic for schizophrenia, including the negative-symptom predominant form. SEPB recommends amisulpride as a first-line option in patients with prominent negative symptoms and normal weight. Watch QT and prolactin.
Third line
Used for treatment-resistant schizophrenia after failure of two adequate trials of antipsychotics from different classes. SEPB positions clozapine as the gold standard; amisulpride is an option when clozapine is contraindicated (prior severe neutropenia) or intolerable.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Direct links to regulator labels. Open in a new tab.
FDA Category C. Pregnancy data are limited. After third-trimester exposure the newborn may show extrapyramidal symptoms, respiratory distress and sleep or feeding disturbance. SEPB continues schizophrenia treatment in confirmed pregnancy because of high relapse risk; doses are not escalated.
Not preferred. Hale L4. Transfers into milk in significant amounts (RID about 11%). The infant may show sedation, poor sucking and extrapyramidal symptoms. SEPB prefers quetiapine or olanzapine when an antipsychotic is needed during breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Amisulpride is evaluated for the following indications with varying evidence strength: Schizophrenia (evidence tier A), Treatment-resistant schizophrenia (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Amisulpride (≥ 1 in 100): Insomnia, Anxiety, Extrapyramidal symptoms (especially at doses above 400 mg/day), Hyperprolactinaemia and related symptoms (galactorrhoea, amenorrhoea, gynaecomastia), Moderate weight gain, Dry mouth. See the Safety section for uncommon and serious reactions.
FDA category C. FDA Category C. Pregnancy data are limited. After third-trimester exposure the newborn may show extrapyramidal symptoms, respiratory distress and sleep or feeding disturbance. SEPB continues schizophrenia treatment in confirmed pregnancy because of high relapse risk; doses are not escalated.
Not preferred. Hale L4. Transfers into milk in significant amounts (RID about 11%). The infant may show sedation, poor sucking and extrapyramidal symptoms. SEPB prefers quetiapine or olanzapine when an antipsychotic is needed during breastfeeding.
Amisulpride is contraindicated in: Hypersensitivity to amisulpride; Prolactin-dependent tumours (breast cancer, prolactinoma); Phaeochromocytoma; QT prolongation (>450 ms men, >470 ms women); Severe hypokalaemia or hypomagnesaemia. Full list in the Safety section.