Amisulpride

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Amisulpride

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Amisulpride

Property Description
Active ingredient Amisulpride (INN)
Form Tablet (oral) and Oral solution
Pharmacological class Atypical Antipsychotic (Second-Generation Antipsychotic)
Common purpose Modulating thought and emotional stability
Origin Synthetic compound (Benzamide derivative)

What Type of Medicine is Amisulpride? (Classification and Identity)

Amisulpride is a synthetic psychotropic agent chemically derived as a substituted benzamide and classified as an Atypical Antipsychotic, often referred to as a Second-Generation Antipsychotic (SGA). This classification places it among medications that demonstrate a targeted approach to managing central nervous system activity. The compound, Amisulpride, serves as the International Nonproprietary Name (INN) for this single active ingredient, which belongs to the Benzamide subclass.

Amisulpride Composition and Available Forms

This medicine is manufactured as a single active ingredient product, containing solely the synthetically produced compound Amisulpride. It is intended for oral administration and is typically available as a solid tablet or a clear oral solution. The availability of the oral solution is a functional feature that allows for flexibility in use, including dose titration. The chemical identity of Amisulpride is defined by its molecular structure, which is classified as a substituted benzamide derivative.

What is the General Therapeutic Purpose of Amisulpride?

The general therapeutic principle of Amisulpride is to act as a highly selective dopamine antagonist, helping to stabilize neurochemical communication within the brain. Its unique mechanism involves targeted action primarily on the D2 and D3 dopamine receptors, an action that is recognized for contributing to its effectiveness in modulating dopaminergic signaling. This focused receptor affinity forms the basis of its general purpose: to assist in the stabilization of thought and emotional processes in individuals affected by certain complex psychiatric conditions.

What side effects are possible with Amisulpride?

Possible side effects and safety information

Amisulpride's safety profile is documented by regulatory authorities, classifying adverse reactions by frequency and physiological system. This classification serves to organize the spectrum of possible effects, from those commonly anticipated to rare, serious events. Safety characteristics are defined across several key domains, including cardiac function, the nervous system, and endocrine activity.

Officially documented adverse reactions are categorized by their incidence:

  • Very Common (occurring in ge 10% of users): Extrapyramidal symptoms, such as tremor, rigidity, and involuntary movements.
  • Common (occurring in ge 1% to <10% of users): Hyperprolactinaemia (increased prolactin levels), somnolence, insomnia, anxiety, agitation, hypotension, weight gain, constipation, and dry mouth. Hyperprolactinaemia may manifest as symptoms like breast pain or erectile dysfunction.
  • Uncommon / Rare (occurring in <1% of users): Includes infrequent but serious effects such as Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal complication. Other rare, serious risks include QT interval prolongation leading to severe ventricular arrhythmias, agranulocytosis, and Venous Thromboembolism (VTE).

Specific safety considerations are noted for certain populations and usage patterns. The medicine is contraindicated for use in children up to the onset of puberty as safety has not been established in this age group. Caution is advised for older adults due to increased risks of sedation and hypotension. Furthermore, its use is restricted in individuals with prolactin-dependent tumours. Time-related patterns exist, where acute movement disorders may appear at the beginning of treatment, while involuntary movements like tardive dyskinesia are usually associated with long-term administration.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official regulatory profile for Amisulpride overdose is defined by the high risk of severe, dose-dependent cardiovascular and neurological toxicity.

Overdose Presentation and Outcomes
Documented Manifestations: Overdose commonly presents with CNS depression (sedation, progressing to coma), and cardiovascular signs such as bradycardia (slow heart rate) and hypotension (low blood pressure) [1.1, 2.2]. Severe cases may involve seizures or acute dystonic reactions [1.4].
Life-Threatening Risks: Overdose is associated with QT interval prolongation and the potential for Torsades de Pointes ( TdP), a dangerous ventricular arrhythmia that may lead to cardiac arrest [1.1, 2.7].

Required Emergency Actions and Management

When to Seek Immediate Medical Help

Regulatory documents state that immediate intervention is required for the management of severe outcomes such as coma, decreased blood pressure, and increased QT interval. Patients must seek immediate medical attention for signs of severe cardiac or neurological toxicity [1.1, 2.2].

Officially Defined Management

  • No specific antidote is known; therefore, management is based on comprehensive symptomatic and supportive treatment [1.1].
  • Monitoring: Continuous ECG monitoring is essential due to the cardiac risks, particularly if QT prolongation is observed, requiring observation for at least 16 hours [3.5].
  • Supportive Care: Maintaining and correcting electrolyte abnormalities (e.g., potassium and magnesium) is a mandated supportive measure. Activated charcoal may be used in specific cases depending on the ingested dose [1.1, 2.2].

Therapeutic Uses of Amisulpride

What Amisulpride Treats: Main Uses and Benefits

This medication is commonly used across conditions presenting with acute or recurrent episodes of psychotic disorders, including conditions such as schizophrenia. It is primarily applied in addressing the severe, often disruptive symptoms associated with these conditions, which include both positive symptoms (like delusions and hallucinations) and negative symptoms (such as emotional blunting and social withdrawal). It offers support for managing thought processes and is relevant for easing the intensity of the episode. This use is also commonly used in clinical settings that involve acute or unstable symptom patterns, contributing to improved comfort during periods of heightened symptoms.


Amisulpride is also relevant for easing challenging symptoms that interfere with daily functioning, and is applied across domains where additional symptomatic support is needed. Symptomatic relief in this domain may help ease the overall symptom burden, assisting with maintaining functional stability. In a distinct clinical setting, the medication is also commonly used to help with symptoms related to physical discomfort by being applied for the prevention and treatment of acute nausea and vomiting following surgical procedures.

“The therapeutic benefit supports the patient during difficult episodes by easing distress, and may assist with maintaining functional stability.”


Quick Fact: Symptomatic Support for Positive Psychotic Symptoms The medicine is considered relevant when symptoms include severe manifestations like delusions, hallucinations, and disorganized thinking, providing support that helps ease the overall symptom load.

Eligibility and Restrictions for Use

Who Can and Cannot Use Amisulpride? — Official Regulatory Information

The eligibility for Amisulpride is strictly defined by regulatory documents, distinguishing between populations allowed for use, those for whom use is restricted, and those for whom use is absolutely prohibited.

Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults (18+ years) are the established population for use.
  • Patients with Hepatic Insufficiency do not typically require dose adjustment or restriction.

Populations for whom use is contraindicated:

  • Children under 15 years of age (prepubertal).
  • Patients with severe renal insufficiency (Creatinine Clearance <10 mL/min).
  • Patients with prolactin-dependent tumours (e.g., prolactinoma or breast cancer) or Phaeochromocytoma.
  • Lactating/Breast-feeding women or patients with known hypersensitivity to the drug.

Age-related eligibility rules:

  • Adolescents (15–18 years): Not recommended due to limited safety and efficacy data.
  • Older Adults (>65 years): Should be used with particular caution.

Condition-specific eligibility rules:

  • Moderate/Mild Renal Insufficiency: Use is conditional and requires a mandatory dose reduction.
  • Parkinson's Disease: Use is restricted; therapy should only be implemented if deemed unavoidable.
  • Congenital Long QT Syndrome: Avoid use.

Pregnancy and lactation eligibility status:

  • Pregnancy: Not recommended.
  • Lactation: Contraindicated.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Amisulpride outlines specific restrictions and cautions, primarily based on pharmacodynamic effects on the heart and central nervous system (CNS).

Classification Interacting Medicines and Substances
Contraindicated Combinations Levodopa and non-antiparkinsonian Dopamine Agonists (e.g., cabergoline, quinagolide) are prohibited due to pharmacological antagonism. All medicines known to induce Torsade de Pointes (e.g., Class Ia and III Antiarrhythmics, methadone) are strictly contraindicated due to the risk of additive QT interval prolongation.
Combinations Requiring Caution CNS Depressants (e.g., narcotics, benzodiazepines, sedative H1 antihistamines) may cause additive depressant effects, leading to reduced alertness. Agents that cause bradycardia or hypokalemia (e.g., potassium-depleting diuretics) should be used with caution, as they worsen the risk of QT prolongation. Antihypertensive drugs may have additive hypotensive effects.
Exposure/Metabolic Notes Co-administration with Clozapine may result in an increase in Amisulpride plasma levels. Amisulpride is weakly metabolized; therefore, the most significant interactions are pharmacodynamic, not typically CYP-enzyme-mediated.

Specific Warnings: Official labeling advises against the use of Alcohol as it may enhance the central effects of Amisulpride. In elderly patients, particular caution is recommended with co-administered hypotensive or CNS-depressant medicines due to potentially exacerbated risks of hypotension and sedation. No mandatory timing separation rules for administration are explicitly listed in the regulatory documents.

Mechanism of Action

Amisulpride functions primarily as a selective dopamine D2 and D3 receptor antagonist. This interaction exhibits a concentration-dependent profile within the central nervous system. At lower systemic concentrations, the molecule preferentially occupies and blocks presynaptic D2 and D3 dopamine autoreceptors. The inhibition of these autoreceptors, which normally mediate negative feedback on dopamine release, disinhibits the dopaminergic neuron. This disinhibition results in a net increase in dopamine release into the synaptic cleft, thereby enhancing dopaminergic neurotransmission in targeted pathways.

Conversely, at higher systemic concentrations, amisulpride saturates and blocks postsynaptic D2 and D3 receptors, particularly within the limbic system. This antagonism of postsynaptic receptors leads to a reduction in dopamine signal transduction in regions characterized by heightened dopaminergic activity. The net system-level physiological consequence is a differential modulation of dopamine signaling: enhanced release and transmission at lower concentrations via autoreceptor block, and reduced postsynaptic signal transduction at higher concentrations via direct receptor block. Amisulpride demonstrates negligible affinity for serotonergic, adrenergic, histaminergic, and cholinergic receptors.

Dosage and Administration Information

Amisulpride is administered via two primary official routes, depending on the clinical context: the oral route (tablets or solution) for ongoing care, and the intravenous (IV) route for acute, short-term use in a surgical setting. The established dosing and frequency patterns are specific to the administration route and the total daily dose.

Official Administration Guidelines

Indication Context Standard Adult Dosing (Official Range) Frequency/Route
Ongoing Oral Care (Acute Symptoms) 400 mg/day to 800 mg/day (Max: 1200 mg/day) Once or twice daily (oral)
Ongoing Oral Care (Lower-Dose Use) 50 mg/day to 300 mg/day Once daily (oral)
Acute Surgical Setting (Prevention) Single dose of 5 mg Single IV injection
Acute Surgical Setting (Treatment) Single dose of 10 mg Single IV injection

Frequency and Timing: For oral use, total daily doses of 300 mg or less are typically administered once daily. If the oral daily dose exceeds 300 mg or 400 mg (depending on the source label), the total quantity must be divided into two separate daily intakes to be taken as prescribed.

Dose Adjustments and Special Conditions:

  • Renal Impairment: The oral dose must be reduced to half if the creatinine clearance is between 30 –60 mL/min and to one third if the clearance is between 10 –30 mL/min. No dosage adjustment is necessary for hepatic impairment.
  • IV Administration: The injection is ready for use, requires no dilution, and must be administered over a short period of 1 to 2 minutes.
  • Age: Use is not established in children, and the medicine is generally contraindicated in children up to puberty.

Recent Clinical Evidence

Research evidence / Overview of studies for Amisulpride

Evidence for use in Psychotic Disorders

The research for use in conditions like schizophrenia relies mainly on Randomized Controlled Trials (RCTs) examining the medicine against placebo or other antipsychotics. Studies monitored changes in symptom severity using scales like the PANSS, exploring how symptoms evolved during periods of heightened activity. Research examined patterns related to both positive and negative symptoms. While findings describe group patterns, the results apply only to the populations studied, and the certainty regarding long-term effects are not fully established.

Evidence for use in Postoperative Nausea and Vomiting

The evidence base for acute physical discomfort after surgery also comes from placebo-controlled RCTs, focusing on patients at high risk for nausea and vomiting. Studies monitored the Complete Response (CR) rate within 24 hours of administration. This research mainly focuses on acute, short-term outcomes, meaning there is limited information for long-term outcomes in this setting.

Comparative Trials, Long-Term Follow-up, and Uncertainties

Comparative research was conducted against placebo and active treatments for both indications, helping to contextualize measured outcomes. Long-term studies, typically up to one year for psychotic disorders, tracked the consistency of initial outcomes and symptom recurrence. However, data for certain groups remain insufficient, most notably for children and adolescents (under 18), as existing research is primarily focused on adults. The comparative evidence is lacking in some specific scenarios, and research is ongoing to contribute to the broader evidence landscape.

Frequently Asked Questions (FAQ)

Common questions about Amisulpride (FAQ)

Q: Is Amisulpride available in different tablet strengths?

Regulatory documents state that Amisulpride is manufactured and available in several oral tablet strengths. Common strengths include 50 mg, 100 mg, 200 mg, and 400 mg formulations. The strength prescribed is determined by the specific use and individual needs.


Q: How is Amisulpride related to other similar medications?

Amisulpride is officially classified as an atypical antipsychotic. Its regulatory profile highlights a selective action on dopamine D2 and D3 receptors. Official documents emphasize that this selectivity gives it a unique pharmacological profile compared to other medicines in the same class.


Q: Does Amisulpride treat conditions like depression or anxiety?

Amisulpride is officially indicated for the treatment of acute and chronic schizophrenic disorders. In addition, the drug has received regulatory approval in some jurisdictions for the prevention and treatment of nausea and vomiting following surgery. The official product information does not list major depressive disorder or generalized anxiety disorder as primary indications.


Q: Is Amisulpride the same compound as sulpiride?

No, Amisulpride is not the same compound as sulpiride. They are distinct medicines that belong to the same chemical class, known as substituted benzamide derivatives. This means they share a similar basic chemical structure but have different properties and regulatory profiles.


Q: What signs might indicate a potentially serious side effect from Amisulpride?

Official safety information documents a range of serious, though rare, effects. These include signs of Neuroleptic Malignant Syndrome (e.g., high fever, severe muscle stiffness) and changes in heart rhythm (e.g., a fast, pounding, or irregular heartbeat, or fainting). Blood problems, which may show up as an unexplained fever or sore throat, are also listed as a concern.


Q: Are there side effects or withdrawal symptoms associated with stopping Amisulpride?

Official regulatory documents state that withdrawal effects have been described after abruptly stopping high doses of this class of medicine. These may include muscle stiffness or unusual body movements. Therefore, to manage this risk, the dose is typically reduced gradually under professional supervision.


Q: How long does it usually take for Amisulpride to begin working?

The time it takes for Amisulpride to show its full therapeutic effects can vary among individuals. Official guidance indicates that while full benefits may take several weeks to realize, the medication should be taken consistently and regularly for a few weeks before the full effect is felt.


Q: What should be done in case a single dose of Amisulpride is missed?

Official product information provides guidance for missed doses, which generally involves taking it as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped entirely. Regulatory guidance states that a double dose should not be taken to compensate for a missed dose.


Q: Is Amisulpride intended for long-term or short-term use?

Amisulpride is authorized for both acute and chronic use, depending on the indication. It is used for acute, short-term treatment in certain medical contexts, such as following surgery. It is also utilized for long-term, ongoing treatment of chronic psychiatric conditions.


Q: Does the timing of taking Amisulpride matter every day?

Patient information suggests consistency, advising that efforts be made to take the prescribed doses at the same time(s) each day. Following a regular schedule helps to maintain the appropriate concentration of the medicine in the body.


Q: What is the usual recommended timeframe for continued use of Amisulpride?

Official guidance indicates that treatment for chronic conditions is generally long-term. Patients are advised to continue use unless instructed otherwise by a doctor, as the appropriate duration is determined by individual patient needs.


Q: Is it safe to take Amisulpride with over-the-counter pain relievers?

Official labeling describes the importance of patients informing their doctor of all concomitant therapy, including any over-the-counter (OTC) drugs. This is due to the potential for interactions or additive side effects when combining medicines. Specific guidance regarding the combination of Amisulpride with over-the-counter pain relievers is determined by a healthcare provider.


Q: Are there any specific foods or drinks to avoid while using Amisulpride?

Patient information indicates that oral tablets are typically swallowed with water, and if possible, taken before a meal. Alcohol is specifically noted in regulatory documents and should be avoided, as it may enhance the central nervous system effects of the medicine.


Q: Does Amisulpride interact with common herbal supplements?

Yes, official regulatory guidance describes the necessity of patients reporting the use of all concomitant treatments, including dietary or herbal supplements, to their doctor. This is standard caution, as even natural supplements can potentially affect how prescription medicines work or increase the risk of side effects.


Q: Are there specific antibiotics or antifungal medicines that interact with Amisulpride?

Yes, Amisulpride is strictly contraindicated with any medicine known to induce Torsade de Pointes. This includes certain antibiotics and antifungals that can prolong the heart's QT interval, posing a serious risk. Regulatory guidance emphasizes that the use of any medicine that affects heart rhythm should be reviewed by a doctor.


Q: Is Amisulpride suitable for people with a history of heart disease or high blood pressure?

Amisulpride requires particular caution in patients with pre-existing heart rhythm problems, such as congenital long QT syndrome, or conditions that increase the risk of low blood pressure (hypotension). Regulatory information highlights that any history of heart issues must be fully assessed prior to prescribing.


Q: Does Amisulpride carry any official warnings about operating vehicles or machinery?

Yes, Amisulpride can cause drowsiness or sedation. Due to the risk of drowsiness, patients are advised in official warnings to refrain from driving or operating machinery until the effects of the medicine on their alertness are known.


Q: Is Amisulpride considered habit-forming or associated with dependency?

The medicine is not officially described in regulatory documents using terms like 'habit-forming' or 'addictive.' However, the official labeling does describe that stopping treatment suddenly can lead to withdrawal effects. Therefore, the dose should be reduced gradually under professional supervision.


Q: How does Amisulpride compare to older medications in the same class?

Regulatory documents note Amisulpride's selective receptor binding profile. Unlike some older antipsychotics, the official information emphasizes that Amisulpride demonstrates negligible affinity for serotonin, alpha-adrenergic, histamine, and cholinergic receptors.


Q: Where can I find the official regulatory documents for Amisulpride?

Official safety and use information is available in the Patient Information Leaflet (PIL) found inside the medicine package. Detailed professional summaries, known as Summary of Product Characteristics (SmPCs), are also published publicly by regulatory bodies like the EMA and MHRA.


Q: Does the physical appearance or color of the Amisulpride tablet vary?

Yes, the official description of the tablets varies depending on the strength. While all are generally white to off-white, the shape (e.g., round versus oblong) and the engraving codes can be different for each dosage strength.


Q: Is it important whether Amisulpride is taken with or without food?

Patient information advises that the oral tablets are best taken before a meal. Following this instruction helps to optimize how the body absorbs the medicine.

How should Amisulpride be stored and disposed of?

How to Store and Dispose of Amisulpride?

Storage requirements for Amisulpride vary depending on the formulation. Official labeling indicates that tablets require no special storage precautions concerning temperature.

The intravenous injection solution, however, must be protected from light to maintain stability. The solution must be used within 12 hours after the vial is removed from its protective carton. Before use, the solution must be visually inspected, and if particulate matter or discoloration is present, it must be discarded.

All Amisulpride products must be stored out of the sight and reach of children.

Disposal of unused or expired Amisulpride must follow local regulations or community drug take-back programs. Official guidance advises against flushing the medicine down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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