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Amisulpride

(Barhemsys®)

Amisulpride

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 5 mg/2 mL [2.5 mg/mL], 10 mg/4 mL [2.5 mg/mL])
Drug ClassDopamine-2 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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  • Barhemsys (amisulpride) is indicated in adults for the prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class, and for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Postoperative Nausea and Vomiting (PONV): Amisulpride significantly improved the incidence of complete response (no emesis and no rescue antiemetic use) compared to placebo, with a relative risk (RR) of 1.30 (95% CI: 1.20-1.41) at a 5 mg dose. NK1 receptor antagonists demonstrated high efficacy, comparable to some drug combinations, in preventing vomiting.
  • Depressive Symptoms: Amisulpride 50 mg/day resulted in a larger reduction in depressive symptoms compared to placebo (SMD = -0.70, 95% CI: -0.92, -0.49) and showed comparable efficacy to SSRIs, amineptine, imipramine, and amitriptyline in treating dysthymia. Higher doses of amisulpride (>400 mg/day) were comparable to olanzapine and risperidone in individuals with schizophrenia.
  • Granisetron and amisulpride are likely to have little or no increase in any adverse event compared to placebo, with no convincing evidence of serious adverse events associated with other single drugs compared to placebo.
  • Amisulpride was superior to placebo in tolerability for dysthymia (OR = 3.94, CI 95% 1.07, 14.48) and comparable to SSRIs (OR = 0.94, CI 95% 0.55, 1.62). The adverse event profile of amisulpride was generally similar to placebo, with specific adverse events not detailed.
  • The evidence primarily focused on adults undergoing general anesthesia, with a significant emphasis on women (83% in multiple reviews), particularly those undergoing gynecologic or gastrointestinal surgery. Additionally, studies included 2,065 patients with dysthymia, major depression, or schizophrenia, focusing on depressive symptoms in major psychiatric disorders. The mean age of the overall population was 42 years. There is no specific subgroup information beyond these demographics.