Amisulpride (Solian)

Traditional use since Introduced in the 1990s (Not available in the USA for psychiatric use)

Reviewed by the HeyPsych Medical Review Board

Board-certified psychiatrists and mental health professionals

Published November 28, 2025•Updated November 28, 2025•Reviewed November 28, 2025

Clinical summary for Amisulpride (Solian): Solian (amisulpride) is a medicine used to treat schizophrenia. The dose matters: lower doses are often used for symptoms like low motivation or emotional “flatness,” while higher doses focus on symptoms like hearing voices or having fixed false beliefs. Your kidneys clear most of this drug, so doses must be adjusted if you have kidney problems. It is not currently approved for psychiatric treatment in the United States.

Primary Uses

Primary Indications

Schizophrenia

Off-Label Uses

Schizoaffective disorder (psychotic symptoms)

Patient-Friendly Explanation

Amisulpride is mainly prescribed for schizophrenia, whether symptoms are new (acute) or long-standing (chronic). In some cases, it may also be used for related conditions that involve psychosis, such as schizoaffective disorder, depending on local guidelines and prescriber judgment.

What People Feel

Everyone responds differently, but these are common patterns people describe on amisulpride:

Positive Symptom Relief

"The voices got quieter and less constant over a few weeks."

How Fast It Works

After an oral dose, amisulpride shows two absorption peaks (about 1 hour and 3–4 hours post-dose). The elimination half-life is approximately 12 hours, supporting once- or twice-daily dosing depending on the total daily dose.

1 hour

First absorption peak after an oral dose.

3–4 hours

Second absorption peak, reflecting delayed absorption.

≈12 hours

Elimination half-life, allowing once- or twice-daily dosing.

Several days to weeks

Clinical improvement in psychotic symptoms typically emerges gradually over this period.

How Well It Works

Treatment Response at 4 Months

vs 47%

Active

71%

Placebo

47%

In a major clinical trial, about 7 in 10 patients with schizophrenia responded to amisulpride treatment, compared with about 5 in 10 taking haloperidol. This means for every 4 people treated with amisulpride instead of haloperidol, 1 additional person achieves a meaningful clinical response. Amisulpride improves both positive symptoms (hallucinations, delusions, disorganized thinking) and negative symptoms (emotional flattening, social withdrawal, lack of drive), with particularly strong effects on negative symptoms.

Warnings & Precautions ⚠️

Amisulpride is not FDA-approved in the United States and therefore does not carry an official US Boxed Warning. However, major safety concerns include QT interval prolongation, Neuroleptic Malignant Syndrome (NMS), and increased cerebrovascular and mortality risk in elderly patients with dementia-related psychosis.

→Do not stop this medication suddenly; your prescriber will usually reduce the dose slowly to help prevent withdrawal symptoms or relapse.
→Seek emergency help right away if you develop high fever, severe muscle stiffness, confusion, or a very fast or irregular heartbeat.
→Tell your doctor if you notice yellowing of your skin or eyes, very dark urine, or severe stomach pain—these can be signs of liver problems.
→Because this medicine can cause drowsiness or dizziness, be cautious with driving, operating machinery, or other activities requiring full alertness.
→Inform your clinician about any history of heart rhythm problems, stroke, blood clots, seizures, or breast/pituitary tumors before starting treatment.

Side Effects

Movement symptoms, prolactin-related effects, and sedation are the key side effects. Many are dose-related and can often be improved with dose adjustments or adjunctive treatments.

Common Things People Notice

Stiffness, tremor, or restlessness (movement side effects)
Breast changes or milk production, menstrual changes, or sexual side effects (from high prolactin)
Sleepiness or tiredness
Weight gain
Dizziness or low blood pressure when standing

Common Side Effects

Very common

Extrapyramidal symptoms (tremor, rigidity, hypersalivation, akathisia, dyskinesia)— Movement side effects are dose-related and tend to be mild to moderate. They are much less common at lower doses (50–300 mg/day).

Common

Acute dystonia (e.g., muscle spasms, abnormal postures)— These symptoms usually respond to anti–Parkinson’s medicines and dose adjustment.

Common

Somnolence (drowsiness)

Common

Insomnia, anxiety, or agitation

Common

Hyperprolactinemia (elevated prolactin)— High prolactin may cause breast tenderness or enlargement, menstrual changes, milk production, or sexual side effects.

Common

Weight gain

Common

Hypotension (low blood pressure)

Common

Gastrointestinal symptoms (constipation, nausea, vomiting, dry mouth)

Common

Blurred vision

⚠️ Serious Side Effects

Neuroleptic Malignant Syndrome (NMS): a rare but life-threatening reaction with fever, muscle rigidity, and autonomic instability.
QT interval prolongation and serious ventricular arrhythmias (including Torsades de pointes and sudden death).
Venous thromboembolism (VTE), such as deep vein thrombosis or pulmonary embolism.
Severe blood dyscrasias such as agranulocytosis (markedly low white blood cell count).
Benign pituitary tumors (prolactinoma) in the context of sustained hyperprolactinemia.
Severe hepatotoxicity or clinically significant liver injury.

Drug Interactions

With: Non-antiparkinsonian dopamine agonists (e.g., cabergoline, quinagolide)

Risk: Opposing pharmacologic effects on dopamine; may cancel each other’s benefits.

Action: Contraindicated. Avoid using together.

With: Citalopram, escitalopram, domperidone, hydroxyzine, piperaquine

Risk: Additive QT prolongation, with increased risk of Torsades de pointes.

Action: Contraindicated. Do not combine.

With: Class Ia/III antiarrhythmics and certain other antipsychotics

Risk: Increased risk of clinically significant QT prolongation and arrhythmias.

Action: Avoid if possible; if essential, use close ECG and electrolyte monitoring.

With: Alcohol

Risk: Enhanced sedation and impaired judgment or coordination.

Action: Avoid alcohol use during treatment.

With: Levodopa and other antiparkinsonian dopamine agonists

Risk: Mutual antagonism of therapeutic effects.

Action: If combination is necessary, use the lowest effective doses and monitor closely; often one of the drugs must be reduced or withdrawn.

With: Methadone, hydroxychloroquine, and certain antiparasitics

Risk: Increased QT prolongation and risk of Torsades de pointes.

Action: Avoid combination where possible; if unavoidable, monitor ECG and electrolytes.

With: Sodium oxybate

Risk: Potentiated CNS depressant effects (excessive sedation or respiratory depression).

Action: Avoid combining if possible.

With: Other sedative drugs (e.g., benzodiazepines, sedating antihistamines, opioids)

Risk: Additive CNS depression and impaired psychomotor performance.

Action: Use cautiously, with the lowest effective doses and careful monitoring.

With: Bradycardia-inducing drugs (e.g., beta-blockers, certain calcium channel blockers)

Risk: Higher risk of significant QT prolongation and arrhythmia.

Action: Monitor heart rate and ECG; adjust therapy if needed.

With: Potassium-depleting agents (e.g., some diuretics, laxatives)

Risk: Low potassium increases the risk of QT prolongation and Torsades de pointes.

Action: Correct low potassium before and during therapy; monitor electrolytes regularly.

With: Lithium

Risk: Possible increased risk of NMS or lithium toxicity.

Action: Monitor clinically for toxicity and consider serum lithium levels as indicated.

With: Certain antibiotics (e.g., azithromycin, ciprofloxacin), anagrelide, ondansetron

Risk: Additional QT prolongation risk.

Action: Use only with ECG and electrolyte monitoring when benefits clearly outweigh risks.

With: Antihypertensive agents

Risk: Increased risk of symptomatic hypotension or dizziness.

Action: Monitor blood pressure and adjust antihypertensive doses when necessary.

Tapering & Safe Discontinuation

As with other antipsychotics, amisulpride should generally be withdrawn gradually rather than stopped abruptly. A slow taper can help reduce the risk of rebound or withdrawal symptoms (such as nausea, vomiting, insomnia, or new movement problems) and lower the chance of sudden relapse of psychotic symptoms.

Patient-Friendly Explanation

Do not stop taking amisulpride on your own, even if you feel better. Your prescriber will usually lower your dose step by step over time to reduce the risk of withdrawal symptoms or a return of psychosis.

Key Points

Avoid sudden discontinuation: abrupt stopping increases the risk of withdrawal symptoms and relapse.
Taper slowly over weeks to months where possible, especially after long-term treatment or high doses.
Monitor for nausea, vomiting, insomnia, anxiety, or new movement symptoms during dose reductions.
Watch closely for early signs of psychotic relapse (e.g., increased suspiciousness, voices returning) and adjust the plan promptly.

Dosing & Administration

Adult Dosing

start: Individualized based on symptom type and severity.

predominantly negative: 50 to 300 mg once daily (with an optimal dose around 100 mg/day for many patients).

mixed or acute psychotic: 400 to 800 mg/day (maximum 1,200 mg/day in divided doses).

notes: Daily doses of 400 mg or less are typically given once daily. Doses above 400 mg/day should be split into two doses (morning and evening). For maintenance, use the lowest effective dose once symptom control is achieved.

Renal Dose Adjustments

Condition	Dose
Creatinine clearance 30–60 mL/min (moderate renal impairment)	Reduce standard dose by about half.
Creatinine clearance 10–30 mL/min (severe renal impairment)	Reduce standard dose to about one third.
Creatinine clearance < 10 mL/min (serious renal insufficiency)	Contraindicated.

Hepatic Dose Adjustments

Hepatic insufficiency: Dose adjustment is generally not required because amisulpride is minimally metabolized by the liver.

Patient-Friendly Explanation

Your dose is chosen based on your main symptoms. If your main issues are low motivation and “flat” emotions, the dose is usually lower and often taken once a day. If you have active psychotic symptoms like hearing voices or strong paranoid ideas, the dose is higher and usually split into two doses per day.

Pregnancy, Breastfeeding, Special Groups

Use amisulpride cautiously in special populations. Balance potential benefits against risks, paying close attention to renal function, cardiovascular risk, and limited data in pregnancy and lactation.

👶Pregnancy

Use during pregnancy is generally not recommended unless the expected benefits outweigh potential risks. Babies exposed during late pregnancy may show movement problems or withdrawal-like symptoms after birth and should be monitored.

🤱Breastfeeding

Amisulpride is excreted into breast milk in clinically relevant amounts. Decisions about breastfeeding versus treatment should balance the benefits of therapy for the mother against potential risks to the infant.

👧Children & Adolescents (Under 18)

Contraindicated in children and adolescents under 15 years of age due to lack of sufficient safety and efficacy data.

👴Older Adults (65+)

Use cautiously in older adults, especially those with dementia-related psychosis, due to increased risk of stroke, low blood pressure, sedation, and mortality. Dose reductions may be required in the presence of renal impairment.

Monitoring

Baseline and periodic ECGs, especially in patients with cardiac risk factors or when used with other QT-prolonging drugs.
Serum electrolytes (particularly potassium and magnesium) when indicated.
Liver function tests if symptoms suggest liver injury.
Renal function (creatinine clearance) before starting and periodically during treatment, to guide dose adjustments.
Weight, fasting glucose, and lipid profile to monitor for metabolic changes.
Clinical signs of venous thromboembolism (e.g., leg swelling, chest pain, shortness of breath).
Complete blood count if signs of infection or unexplained fever develop (to evaluate for agranulocytosis or neutropenia).
Prolactin levels and related clinical features (galactorrhea, menstrual disturbances, sexual dysfunction) when clinically indicated.
Neurologic examination for extrapyramidal symptoms and tardive dyskinesia.

Available Formulations

Film-coated, scored tablets: 100 mg, 200 mg, 400 mg
Intramuscular (IM) formulation: for short-term use in acute episodes, up to 400 mg/day for a few days

Mechanism of Action

Amisulpride is a selective antagonist at dopamine D2 and D3 receptors, with preferential activity in limbic brain regions. At lower doses (approximately 50–300 mg/day), it primarily blocks presynaptic D2/D3 autoreceptors, which enhances dopaminergic transmission and is thought to improve negative symptoms. At higher doses (around 400–1,200 mg/day), it predominantly blocks postsynaptic D2/D3 receptors, reducing excessive dopamine signaling and improving positive symptoms.

Patient-Friendly Explanation

This medicine mainly works on dopamine, a brain chemical involved in thinking and motivation. At lower doses it nudges dopamine activity up in certain areas to help with low mood, low energy, and social withdrawal. At higher doses it blocks too much dopamine activity to calm down hallucinations and strong suspicious or unusual beliefs.

Clinical Pearls & Place in Treatment ✨

Amisulpride is an atypical antipsychotic with dose-dependent pharmacology that allows targeting of both negative and positive symptoms of schizophrenia. Where available, it is one of several options for acute and maintenance treatment. Because it is primarily renally cleared and strongly prolactin-elevating, it is particularly important to individualize dosing based on kidney function and to monitor for prolactin-related side effects. It is not approved for psychiatric use in the United States, so other atypical antipsychotics are typically used there instead.

Frequently Asked Questions

Is Amisulpride (Solian) available in the United States?

Amisulpride (Solian) is not currently approved for psychiatric use in the United States. It is prescribed in several other countries for schizophrenia, but patients in the US are usually treated with other atypical antipsychotics that are FDA-approved.

What is Amisulpride used for?

Amisulpride is primarily used to treat acute and chronic schizophrenia. It can help with both ‘positive’ symptoms such as hallucinations, delusions, and disorganized thoughts, and ‘negative’ symptoms such as emotional blunting, low motivation, and social withdrawal.

What dose of Amisulpride is used for negative symptoms?

For predominantly negative symptoms, typical daily doses of amisulpride range from 50 to 300 mg, with many patients responding around 100 mg per day. These doses are usually taken once daily and are designed to maximize benefit on negative symptoms while limiting side effects.

Does Amisulpride cause QT prolongation?

Yes. Amisulpride can prolong the QT interval on the ECG, and this effect is dose-related. Serious rhythm problems, including torsades de pointes and sudden death, have been reported, especially in people with other risk factors or when combined with QT-prolonging drugs. Before and during treatment, clinicians should evaluate heart rhythm, electrolyte levels, and concomitant medications.

Can I stop taking Amisulpride suddenly?

Stopping amisulpride abruptly is not recommended. Sudden discontinuation can lead to withdrawal symptoms such as nausea, vomiting, insomnia, and new movement problems, and may trigger a rapid return of psychotic symptoms. Any dose changes should be made gradually and under close medical supervision.

This medication information is for educational purposes only and is not a substitute for professional medical advice. Always consult your healthcare provider before starting, stopping, or changing any medication. Never take medication without a prescription from a licensed healthcare provider.

Interested in this treatment?

This information is for educational purposes. Always consult with a qualified healthcare provider before starting any new treatment.

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Amisulpride (Solian)

Traditional use since Introduced in the 1990s (Not available in the USA for psychiatric use)

Reviewed by the HeyPsych Medical Review Board

Board-certified psychiatrists and mental health professionals

Published November 28, 2025•Updated November 28, 2025•Reviewed November 28, 2025

Condition

Dose

Creatinine clearance 30–60 mL/min (moderate renal impairment)

Reduce standard dose by about half.

Creatinine clearance 10–30 mL/min (severe renal impairment)

Reduce standard dose to about one third.

Creatinine clearance < 10 mL/min (serious renal insufficiency)

Contraindicated.