Skip to content

Amisulpride

Published: July 26, 2026Updated: July 26, 2026

Amisulpride is an atypical antipsychotic medication that works by selectively blocking dopamine D2 and D3 receptors in the brain. It is primarily used to treat schizophrenia and related psychotic disorders, including acute episodes and persistent negative symptoms.

Quick summary

An atypical antipsychotic that treats schizophrenia by blocking dopamine D2/D3 receptors.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
N05AL05
RxNorm
46303
Generic
Amisulpride
Class
atc-n05
Brands
Barhemsys
Availability
rx
Lactation
unknown
Routes
oral
Forms
injection, tablet, solution
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses above 2g associated with severe toxicity
Chronic overdose: prolonged high-dose therapy may lead to accumulation and toxicity
Immediate actions
supportive care, gastric lavage within 1-2 hours, activated charcoal
Antidote
no specific antidote(supportive care is mainstay of treatment)
Poison Control: 1-800-222-1222

Special Populations

8 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits outweigh potential risks to fetus

Monitor

regular fetal monitoring and ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue before delivery if possible; monitor neonates for extrapyramidal symptoms

Monitor

neonatal monitoring for withdrawal symptoms and movement disorders

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

contraindicated

Key Recommendations

avoid breastfeeding during treatment with amisulpride

Monitor

if breastfeeding is attempted, monitor infant for sedation and developmental milestones

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
C
Dose Adjustment

dose_reduction_recommended

Key Recommendations

start at lowest effective dose; increased risk of mortality in elderly with dementia-related psychosis

Monitor

regular monitoring of renal function, blood pressure, and extrapyramidal symptoms

Use with caution and monitor for adverse effects.

?

pediatric_age

adolescents 12 17
unknown
FDA Category
C
Dose Adjustment

not_established

Key Recommendations

not recommended; safety and efficacy not established in pediatric population

Monitor

if used, close monitoring for metabolic changes and growth parameters

⚠

renal_impairment

mild
caution
FDA Category
C
Dose Adjustment

dose_reduction_needed

Key Recommendations

reduce dose by 50% for creatinine clearance 30-50 mL/min

Monitor

monitor renal function regularly; adjust dose based on clinical response

Use with caution and monitor for adverse effects.

✗

renal_impairment

severe
unsafe
FDA Category
C
Dose Adjustment

avoid_or_significant_reduction

Key Recommendations

reduce dose by 70% for creatinine clearance below 10 mL/min; use with extreme caution

Monitor

frequent renal function monitoring and plasma concentration monitoring if available

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
C
Dose Adjustment

no_significant_adjustment

Key Recommendations

no major dose adjustment required; use with caution

Monitor

monitor liver function tests periodically

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2020

Barhemsys intravenous formulation approval

drug_classFDA
2023

Drug class

Value:Antiemetic (Dopamine D2/D3 receptor antagonist)

Pharmacological classification

usageFDA
2023

Primary indication

Value:Prevention and treatment of postoperative nausea and vomiting (PONV)

Therapeutic use

Treatment of schizophrenia (positive and negative symptoms), acute manic episodes, and psychotic depression. May also have antiemetic properties due to action on the chemoreceptor trigger zone.

Selectively antagonizes dopamine D2 and D3 receptors, reducing dopaminergic neurotransmission in mesolimbic, mesocortical, and tuberoinfundibular pathways, which helps reduce psychotic symptoms.

May cause extrapyramidal symptoms, hyperprolactinemia, QT prolongation, and metabolic changes. Use with caution in patients with epilepsy, Parkinson's disease, or cardiac conditions. Not recommended for elderly patients with dementia-related psychosis.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy