Amisulpride

(Barhemsys®)

Barhemsys®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 5 mg/2 mL [2.5 mg/mL], 10 mg/4 mL [2.5 mg/mL])
Drug ClassDopamine-2 (D2) antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in adults for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • Indicated in adults for treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Amisulpride demonstrated significant effectiveness in preventing postoperative nausea and vomiting (PONV), with a 24-hour complete response rate (no emesis and no rescue antiemetic use) relative risk (RR) of 1.30 (95% confidence interval (CI): 1.20-1.41), particularly at a 5 mg dose (relative risk (RR): 1.28, 95% CI: 1.18-1.39).
  • In treating depressive symptoms in major psychiatric disorders, amisulpride at 50 mg/day showed greater symptom reduction compared to placebo (standardized mean difference (SMD) = -0.70, 95% CI: -0.92, -0.49), and it was comparable in efficacy to selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants in the treatment of dysthymia.
  • Amisulpride showed a significantly higher rate of intolerability-related discontinuations in monotherapy for major depressive disorder (MDD) compared to placebo.
  • In postoperative nausea and vomiting (PONV) prevention, the adverse event profile of amisulpride was generally similar to placebo.
  • The reviewed studies provide information on population types relevant to schizophrenia treatment (patients with sleep-related adverse effects), antidepressant-induced apathy (patients receiving SSRIs), major depressive disorder (adults receiving monotherapy or adjunctive antipsychotic therapy), and postoperative nausea and vomiting (adults undergoing surgery with general anesthesia).

Product Monograph / Prescribing Information

Document TitleYearSource
Barhemsys (amisulpride) Prescribing Information.2022Acacia Pharma, Inc., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines