Evigrade
DrugsCosmetic ingredientsCalculatorsInteractionsEvigrade SkinEvigrade Meds ↗
ConditionsJournalMethodologyPro for practitioners
ESRU

Amisulpride

AEMPS

Atypical antipsychotic of the benzamide class

ATC code: N05AL05

Brand names: Solian

Updated · Methodology

Indications

A

Postoperative nausea and vomiting

Second line

Low-dose intravenous amisulpride (5–10 mg) is used to prevent and treat postoperative nausea and vomiting. Several double-blind, placebo-controlled RCTs, a meta-analysis and the Fourth Consensus Guidelines on postoperative nausea and vomiting include amisulpride as one of the recommended antiemetics. The antiemetic dose (5–10 mg IV) is far below the antipsychotic dose (400–800 mg orally) and does not meaningfully prolong the QT interval. In Spain the intravenous form (Barhemsys) is not registered and CIMA lists only oral tablets; the basis is approval (2020) and international consensus.

Sources

  1. Anesthesiology: Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. (2017)
  2. Anesthesiology: Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. (2018)
  3. Anesthesiology: Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Trial. (2019)
  4. Eur J Clin Pharmacol: Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. (2020)
  5. Anesth Analg: Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. (2020)
  6. Anesth Analg: Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting. (2021)

ICD-10: R11 · ICD-11: MD90

A

Schizophrenia

First line

Atypical antipsychotic for schizophrenia, including the negative-symptom predominant form. Meta-analyses confirm its efficacy, including in prominent negative symptoms. Watch the QT interval and prolactin.

Sources

  1. Am J Psychiatry: Amisulpride, an unusual "atypical" antipsychotic: a meta-analysis of randomized controlled trials. (2002)
  2. AEMPS: Ficha técnica de Amisulprida (2023)
  3. Cochrane Database Syst Rev: Amisulpride versus other atypical antipsychotics for schizophrenia. (2010)
  4. Lancet: Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. (2019)
  5. GuiaSalud: Guía de Práctica Clínica sobre la Esquizofrenia y el Trastorno Psicótico Incipiente (2009)

ICD-10: F20 · ICD-11: 6A20

C

Dysthymia (persistent depressive disorder)

Individual decision

Low-dose amisulpride (50 mg/day) has been studied in dysthymia and subsyndromal depression: RCTs against paroxetine and placebo and a Cochrane review of atypical antipsychotics in depression showed an antidepressant effect comparable to SSRIs. Its role is limited because the drug carries antipsychotic adverse effects (hyperprolactinaemia, extrapyramidal symptoms, dose-dependent QT prolongation) that SSRIs do not. It is not listed in Spanish or European depression guidelines. In Spain only 100, 200 and 400 mg tablets are registered for schizophrenia and there is no 50 mg strength, so this regimen is off-label in Spain. The decision is made individually.

Sources

  1. J Affect Disord: A comparison of paroxetine and amisulpride in the treatment of dysthymic disorder. (2002)
  2. Int Clin Psychopharmacol: Efficacy and safety of amisulpride 50 mg versus paroxetine 20 mg in major depression: a randomized, double-blind, parallel group study. (2002)
  3. Cochrane Database Syst Rev: Second-generation antipsychotics for major depressive disorder and dysthymia. (2010)

ICD-10: F34.1 · ICD-11: 6A72

C

Treatment-resistant schizophrenia

Third line

Used for treatment-resistant schizophrenia after failure of two adequate trials of antipsychotics from different classes. Clozapine remains the gold standard for treatment-resistant schizophrenia. Evidence for amisulpride is limited and conflicting: it mostly concerns amisulpride augmentation of clozapine, and RCT results diverge (the large AMICUS trial showed no significant effect on the primary endpoint, while some smaller studies report partial improvement). Co-administration with clozapine raises amisulpride plasma levels and increases the risk of QT prolongation. The main risks are dose-dependent QT prolongation and hyperprolactinaemia.

Sources

  1. AEMPS: Ficha técnica de Amisulprida (2023)
  2. Ther Adv Psychopharmacol: Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial (2018)
  3. Health Technol Assess: Amisulpride augmentation in clozapine-unresponsive schizophrenia (AMICUS): a double-blind, placebo-controlled, randomised trial of clinical effectiveness and cost-effectiveness (2017)
  4. Schizophr Bull: Clozapine Combination and Augmentation Strategies in Patients With Schizophrenia -Recommendations From an International Expert Survey Among the Treatment Response and Resistance in Psychosis (TRRIP) Working Group (2020)

ICD-10: F20.9 · ICD-11: 6A20

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

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.

Safety

Contraindications

  • Hypersensitivity to amisulpride
  • Prolactin-dependent tumours (breast cancer, prolactinoma)
  • Phaeochromocytoma
  • QT prolongation (>450 ms men, >470 ms women)
  • Severe hypokalaemia or hypomagnesaemia
  • Co-administration with QT-prolonging drugs
  • Breastfeeding

Serious adverse effects

  • QT prolongation and torsades de pointes
  • Neuroleptic malignant syndrome
  • Tardive dyskinesia with long-term therapy
  • Venous thromboembolism
  • Seizures
  • Cognitive decline in older patients with dementia (increased mortality)

Common adverse effects

  • Insomnia
  • Anxiety
  • Extrapyramidal symptoms (especially at doses above 400 mg/day)
  • Hyperprolactinaemia and related symptoms (galactorrhoea, amenorrhoea, gynaecomastia)
  • Moderate weight gain
  • Dry mouth

Uncommon adverse effects

  • QT prolongation and torsades de pointes
  • Neuroleptic malignant syndrome
  • Tardive dyskinesia with long-term therapy
  • Venous thromboembolism
  • Seizures
  • Cognitive decline in older patients with dementia (increased mortality)
  • Hyperprolactinaemia with galactorrhoea, amenorrhoea and gynaecomastia

Pregnancy: can you take Amisulpride?

AEMPS summary of product characteristics (section 4.6): there are not enough clinical data on amisulpride in pregnant women, and its safety in pregnancy has not been established; amisulpride crosses the placenta, and animal studies have shown reproductive toxicity. Amisulpride is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the benefits justify the potential risks. Newborns exposed to antipsychotics, including amisulpride, in the third trimester are at risk of extrapyramidal or withdrawal symptoms of varying severity and duration after birth; agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding problems have been reported. These newborns are monitored carefully.

Breastfeeding: can you take Amisulpride?

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.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions21 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • MajorBromocriptine
    «Levodopa: antagonismo recíproco de efectos entre levodopa y neurolépticos. Amisulprida puede oponerse al efecto de los agonistas dopaminérgicos p. ej., bromocriptina, ropinirol.»

    AEMPS, section 4.5 · Open on CIMA

  • MajorDroperidol
    «Drugs Prolonging the QT Interval: BARHEMSYS causes dose- and concentration-dependent QT prolongation [see Clinical Pharmacology (12.2) ] . To avoid potential additive effects, avoid use of BARHEMSYS…»

    FDA, section 7 · Open on DailyMed

  • MajorOndansetron
    «Drugs Prolonging the QT Interval: BARHEMSYS causes dose- and concentration-dependent QT prolongation [see Clinical Pharmacology (12.2) ] . To avoid potential additive effects, avoid use of BARHEMSYS…»

    FDA, section 7 · Open on DailyMed

  • MajorRopinirole
    «Levodopa: antagonismo recíproco de efectos entre levodopa y neurolépticos. Amisulprida puede oponerse al efecto de los agonistas dopaminérgicos p. ej., bromocriptina, ropinirol.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAmiodarone
    «Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiácidosclass named in the label
    «Antiácidos: La administración conjunta de amisulprida con antiácidos que contengan sales de magnesio o aluminio puede provocar una disminución de los niveles plasmáticos de amisulprida, pudiendo…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiarrítmicosclass named in the label
    «Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantihistamínicosclass named in the label
    «Depresores del SNC: incluyendo narcóticos, analgésicos, antihistamínicos sedantes H1, barbitúricos, benzodiazepinas y otros ansiolíticos, clonidina y derivados.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebarbitúricosclass named in the label
    «Depresores del SNC: incluyendo narcóticos, analgésicos, antihistamínicos sedantes H1, barbitúricos, benzodiazepinas y otros ansiolíticos, clonidina y derivados.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebenzodiazepinasclass named in the label
    «Depresores del SNC: incluyendo narcóticos, analgésicos, antihistamínicos sedantes H1, barbitúricos, benzodiazepinas y otros ansiolíticos, clonidina y derivados.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateClonidine
    «Depresores del SNC: incluyendo narcóticos, analgésicos, antihistamínicos sedantes H1, barbitúricos, benzodiazepinas y otros ansiolíticos, clonidina y derivados.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateClozapine
    «Clozapina: la administración conjunta de amisulprida con clozapina puede aumentar los niveles plasmáticos de amisulprida.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDisopyramide
    «Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLithium
    «Sales de litio: La administración conjunta de amisulprida con sales de litio puede dar lugar a la aparición de síntomas extrapiramidales.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateQuinidine
    «Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSotalol
    «Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • ModerateChlortalidone
    «Sustancias que pueden desencadenar torsades de pointes: - ciertos antipsicóticos: fenotiazinas (por ejemplo, clorpromazina, ciamemazina, levomepromazina, tioridazina, trifluoperazina), benzamidas…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateIndapamide
    «Medicamentos que ocasionan “torsades de pointes”, pero sin limitarse a: benzamidas (ej. amisulprida, sulpirida, sultoprida, tiaprida),»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRivastigmine
    «Dado que la bradicardia constituye un factor de riesgo en la aparición de torsades de pointes, se debe observar con precaución e incluso puede requerirse una monitorización clínica (ECG), si se…»

    AEMPS, section 4.5 · Open on CIMA

  • Amiodarone
    «Medicamentos que inducen Torsades de pointes: Algunos antipsicóticos, como clorpromazina, tioridazina, flufenazina, pimozida, haloperidol, amisulprida y sertindol.»

    AEMPS, section 4.5 · Open on CIMA

  • Lithium
    «Antipsicóticos ( amisulprida , haloperidol, droperidol, mesoridazina, pimozida, sertindol, tioridazina y clozaril )»

    AEMPS, section 4.5 · Open on CIMA

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Amisulpride used for?

Amisulpride is evaluated for the following indications with varying evidence strength: Postoperative nausea and vomiting (evidence tier A), Schizophrenia (evidence tier A), Treatment-resistant schizophrenia (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Amisulpride?

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.

Is Amisulpride safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are not enough clinical data on amisulpride in pregnant women, and its safety in pregnancy has not been established; amisulpride crosses the placenta, and animal studies have shown reproductive toxicity. Amisulpride is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the benefits justify the potential risks. Newborns exposed to antipsychotics, including amisulpride, in the third trimester are at risk of extrapyramidal or withdrawal symptoms of varying severity and duration after birth; agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding problems have been reported. These newborns are monitored carefully.

Is Amisulpride compatible with breastfeeding?

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.

Who should not take Amisulpride?

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.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Apigenin, Aripiprazole, Bromazepam, Chamomile (Matricaria chamomilla / recutita, flowers), Clobazam, Hydroxyzine, Paliperidone, Quetiapine