Amisulpride

Amisulpride is a selective dopamine-2 (D 2 ) and dopamine-3 (D 3 ) receptor antagonist. D 2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings.

• BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.ICD-10: R11.2

• BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride [see Adverse Reactions (6.2) ] . Known hypersensitivity to amisulpride.contraindicated

The recommended dosage of BARHEMSYS: Prevention of PONV, either alone or in combination with another antiemetic : 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia. ( 2.1 ) Treatment of PONV : 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure. ( 2.1 ) See full prescribing information for preparation and administration instructions . ( 2.2 ) 2.1 Recommended Dosage The recommended adult dosage of BARHEMSYS and infusion rate by indication is shown in the table below: Indication Adult Dosage Regimen Prevention of PONV 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia [see Dosage and Administration (2.2) ] . Treatment of PONV 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure [see Dosage and Administration (2.2) ] . 2.2 Preparation and Administration Dilution of BARHEMSYS is not required before administration. BARHEMSYS is chemically and physically compatible with Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer's Solution (also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, and Hartmann's Solution), any of which may be used to flush an intravenous line before or after administration of BARHEMSYS. Protect from light. BARHEMSYS is subject to photodegradation. Administer BARHEMSYS within 12 hours of removal of the vial from the protective carton.

QT Prolongation : Occurs in a dose- and concentration-dependent manner. Avoid use in patients with congenital long QT syndrome and in patients taking droperidol. ECG monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders; electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia); congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval. ( 5.1 , 7.2 ) 5.1 QT Prolongation BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval [see Clinical Pharmacology (12.2) ] . The recommended dosage is 5 or 10 mg as a single intravenous dose infused over 1 to 2 minutes [see Dosage and Administration (2.1) ] . Avoid use in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders; electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia); congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval [see Drug Interactions (7.2) ] .

Most common adverse reactions (≥ 2%) are: Prevention of PONV : increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension. ( 6.1 ) Treatment of PONV : infusion site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to BARHEMSYS in 1,166 patients treated in placebo-controlled trials. 748 of these patients received a dose of 5 mg for prevention of PONV (of whom 572 received another antiemetic concomitantly) and 418 patients received 10 mg for treatment of PONV [see Clinical Studies (14.1 , 14.2) ] . The mean age of the population was 49 years (range 18 to 91 years), 87% female, 80% White/Caucasian, 9% Black, and 1% Asian. Prevention of PONV Common adverse reactions reported in at least 2% of adult patients who received BARHEMSYS 5 mg and at a higher rate than placebo in Studies 1 and 2 for the prevention of PONV are shown in Table 1. Table 1.

Lactation : A lactating woman may pump and discard breast milk for 48 hours after BARHEMSYS administration. ( 8.2 ) 8.1 Pregnancy Risk Summary Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended human dose (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies of amisulpride were conducted in pregnant rats administered oral doses up to 160 mg/kg/day (43 times the exposure based on area under the curve (AUC) at the highest recommended dose of 10 mg) throughout the period of organogenesis. No adverse embryo-fetal developmental effects were observed at any dose level.

Metabolism

After an intravenous infusion, the peak plasma concentration of amisulpride is achieved at the end of the infusion period and the plasma concentration decreases to about 50% of the peak value within approximately 15 minutes. The AUC (0-∞) increases dose-proportionally in the dose range from 5 mg to 40 mg (4-times the maximum recommended dose).

Doses of oral amisulpride (BARHEMSYS is not approved for oral dosing) above 1200 mg/day have been associated with adverse reactions related to dopamine-2 (D 2 ) antagonism, in particular: cardiovascular adverse reactions (e.g., prolongation of the QT interval, torsades de pointes, bradycardia and hypotension) [see Warnings and Precautions (5.1) ] . neuropsychiatric adverse reactions (e.g., sedation, coma, seizures, and dystonic and extrapyramidal reactions). There is no specific antidote for amisulpride overdose. Management includes cardiac monitoring and treatment of severe extrapyramidal symptoms. Since amisulpride is weakly dialyzed, hemodialysis should not be used to eliminate the drug.

• Feb 26, 2020NDANDA209510Acacia

1. 1Drug Ineffective83814%
2. 2Drug Interaction4607.8%
3. 3Weight Increased4347.4%
4. 4Toxicity To Various Agents3936.7%
5. 5Neutropenia3856.5%
6. 6Schizophrenia3275.5%
7. 7Off Label Use3235.5%
8. 8Leukopenia3135.3%
9. 9Akathisia3055.2%
10. 10Extrapyramidal Disorder2985.1%
11. 11Suicide Attempt2794.7%
12. 12Electrocardiogram Qt Prolonged2714.6%
13. 13Somnolence2684.5%
14. 14Drug Abuse2554.3%
15. 15Confusional State2424.1%

Recent PubMed references pinned to Amisulpride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Three-week effect of amisulpride, aripiprazole, and olanzapine on gene expression in peripheral blood in individuals with schizophrenia spectrum disorders.
  The international journal of neuropsychopharmacology · 2026 · Torsvik A, Trentani A, Stokowy TK, et al.
  PMID 42033308DOI 10.1093/ijnp/pyag019
• Formulation and Characterization of Amisulpride-Poly (Lactic-Co-Glycolic Acid) Nanoparticles Coated with Chitosan for Intranasal Delivery.
  AAPS PharmSciTech · 2026 · Khanfar MS, Alaboud SY, Khalil RW, et al.
  PMID 41872643DOI 10.1208/s12249-026-03405-7
• Symptom Network Dynamics during Antipsychotic Treatment in First-Episode Psychosis.
  Schizophrenia bulletin · 2026 · Zandstra MG, Scheepers FE, Lunansky G, et al.
  PMID 41863366DOI 10.1093/schbul/sbag016
• Linking Structural Features of Amisulpride and Sulpiride to Their Photoreactivity and Environmental Fate: The Role of NH(2) Substitution in Photodegradation Behavior.
  Environmental science & technology · 2026 · Wang C, Guo C, Guo R, et al.
  PMID 41705471DOI 10.1021/acs.est.5c13185
• Box-Behnken optimized salting-out assisted liquid-liquid extraction coupled with LC-MS/MS for sustainable amisulpride quantification in human plasma.
  Journal of chromatography. A · 2026 · Serag A, Alosaimi ME, Abduljabbar MH, et al.
  PMID 41616633DOI 10.1016/j.chroma.2026.466727
• Exploring brain structural effects of dopaminergic antagonism and partial agonism in antipsychotic-naïve patients with first-episode psychosis using normative modeling.
  Psychiatry and clinical neurosciences · 2026 · Feveile A, Ambrosen KS, Shalikashvili K, et al.
  PMID 41492137DOI 10.1111/pcn.70017
• Immunomodulatory effects of amisulpride on mammalian macrophages.
  Irish journal of medical science · 2026 · Gürcan MB, Ekimci Gürcan N, Özarslan FS, et al.
  PMID 41288912DOI 10.1007/s11845-025-04188-9
• Using blood methylomes to predict response to amisulpride in the first-episode psychosis in the OPTiMiSE cohort.
  Translational psychiatry · 2025 · Lokmer A, Troudet R, Bacq-Daian D, et al.
  PMID 41052975DOI 10.1038/s41398-025-03561-7

The 10 most recently updated of 81 ClinicalTrials.gov registrations naming Amisulpride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Application of Multimodal Intervention in the Prevention of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery
  Not yet recruiting · Interventional · 212 enrolled · Sir Run Run Shaw Hospital
  NCT07631910updated 2026-06-08
• Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
  Recruiting · Phase 2 · Interventional · 320 enrolled · LB Pharmaceuticals Inc.
  NCT07494305updated 2026-05-11
• Amisulpride for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
  Not yet recruiting · Observational · 526 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07554040updated 2026-04-28
• Enhancing Recovery in Early Schizophrenia
  Active not recruiting · Phase 2 · Interventional · 180 enrolled · Central Institute of Mental Health, Mannheim
  NCT02926859updated 2026-02-03
• Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings
  Not yet recruiting · Early phase 1 · Interventional · 100 enrolled · Stanford University
  NCT07348172updated 2026-01-16
• Magnetic Seizure Therapy for Psychotic Disorders
  Recruiting · Interventional · 50 enrolled · Shanghai Jiao Tong University School of Medicine
  NCT06581302updated 2025-11-25
• Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
  Completed · Phase 2 · Phase 3 · Interventional · 453 enrolled · Acacia Pharma Ltd
  NCT05546359updated 2025-06-25
• An Investigation of Early Life Stress and Depression
  Completed · Phase 1 · Interventional · 153 enrolled · Mclean Hospital
  NCT01701258updated 2025-05-07
• Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery
  Recruiting · Phase 2 · Interventional · 276 enrolled · Instituto do Cancer do Estado de São Paulo
  NCT06887621updated 2025-04-13
• Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa
  Completed · Early phase 1 · Interventional · 31 enrolled · University of California, San Diego
  NCT04128683updated 2025-04-11

CPIC-curated drug–gene pairs for Amisulpride. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• MC4RCPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Amisulpride work?

Amisulpride is a selective dopamine-2 (D 2 ) and dopamine-3 (D 3 ) receptor antagonist. D 2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings.

What is Amisulpride used for?

According to FDA labeling, Amisulpride carries indications including: BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Amisulpride?

Amisulpride is classified as Benzamides, Dopamine-2 Receptor Antagonist, Dopamine D2 Antagonists.

What are the brand names for Amisulpride?

Amisulpride is marketed under brand names including Barhemsys.

What are the contraindications for Amisulpride?

Amisulpride labeling lists contraindications including: BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride [see Adverse Reactions (6.2) ] . Known hypersensitivity to amisulpride.. Always consult the full prescribing information and a clinician.