Solian

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Solian

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Method of action: Antipsychotic, Psycholeptics

Treatment option: Delirium, Hallucinations

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Solian

Quick Facts

Property Description
Active Ingredient Amisulpride
Form Tablet, Oral Solution, Solution for Injection
Pharmacological Class Atypical Antipsychotic (Second-Generation Antipsychotic)
Common Use To stabilize disturbances in thinking and mood
Origin Synthetic Compound (Substituted Benzamide Derivative)

What Type of Medicine is Solian?

Solian is a pharmaceutical product available only by prescription, containing the active substance Amisulpride, a synthetic chemical compound. It is formally classified as an Atypical Antipsychotic, placing it within the second-generation category of psychotropic agents. Amisulpride is chemically a substituted benzamide derivative, a unique class that distinguishes it from many older antipsychotic medications. This specific chemical backbone is clinically recognized for providing high selectivity towards its pharmacological targets.

Composition, Forms, and General Purpose

The core of the medicine is Amisulpride, a single-ingredient compound primarily functioning as a highly selective dopamine D2 and D3 receptor antagonist. This mechanism is characterized by a unique affinity for these specific receptors in the brain’s limbic regions. The drug works by precisely targeting chemical messengers related to emotional and cognitive regulation.

Solian is available in several physical preparations, including the common tablet, a liquid oral solution (beneficial for patients who have difficulty swallowing solids), and forms for injection. The overall therapeutic purpose of this targeted action, which is utilized for the management of psychotic disorders, is to modulate dopamine transmission, helping to re-establish a stable chemical environment in the brain to manage disturbances in thinking and perception.

What side effects are possible with Solian?

The safety profile of Solian (Amisulpride) is officially documented according to government regulatory standards, with adverse reactions categorized by frequency and the physiological system affected.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their documented occurrence in clinical trials. Very Common reactions (affecting 1 in 10 patients or more) include extrapyramidal symptoms, such as tremor and dyskinesia, which may be dose-dependent and often reversible. Common effects (affecting 1 to 10 in 100 patients) include insomnia, anxiety, agitation, somnolence (sedation), weight gain, and increased plasma prolactin levels, which can manifest as breast-related disorders or sexual dysfunction. Gastrointestinal disturbances like constipation and dry mouth are also common.

Serious Adverse Reactions and Safety Notes

The regulatory profile highlights several serious risks, which, though uncommon or rare, are critical safety features. These include the potential for QT prolongation, an effect on heart rhythm, and the risk of venous thromboembolism (VTE), which encompasses deep vein thrombosis and pulmonary embolism. The potentially fatal reaction Neuroleptic Malignant Syndrome (NMS) is also a documented, although not-known-frequency, risk. Severe blood disorders, such as agranulocytosis, are rare but listed safety concerns.

Population-Specific and Exposure-Related Safety: Official labels note specific considerations for older adults, citing an increased risk of orthostatic hypotension and susceptibility to sedative effects. Time-related patterns are noted, such as the appearance of certain extrapyramidal symptoms, like acute dystonia, shortly after treatment initiation, while tardive dyskinesia is typically associated with long-term exposure. Furthermore, the medicine is officially restricted (contraindicated) for use in individuals with conditions like Phaeochromocytoma or prolactin-dependent tumors.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information

The most serious documented manifestations of Solian overdose are an exaggeration of pharmacological effects, affecting the Central Nervous System (CNS) and the Cardiovascular System. Documented CNS presentations include drowsiness, profound sedation, and coma, alongside hypotension and motor symptoms such as extrapyramidal symptoms and the potential for seizures.

Immediate Actions and Severe Outcomes

Immediate medical attention is required if an overdose is suspected, even if symptoms are not severe, or if the affected person collapses or cannot be awakened. Regulatory documents specifically highlight the risk of dose-dependent QT interval prolongation, which may lead to life-threatening ventricular arrhythmias, including Torsades de pointes and cardiac arrest.

Management is strictly symptomatic and supportive, as no specific antidote is known; furthermore, dialysis is ineffective for removal. Continuous cardiac monitoring (ECG assessment) and close monitoring of vital functions are required in a hospital setting until the patient fully recovers from all manifestations.

Therapeutic Uses of Solian

The primary therapeutic use of Solian (Amisulpride) is commonly applied across domains where additional symptomatic support is needed in situations involving distressing symptoms associated with schizophrenic disorders. This includes managing both acute and chronic manifestations of the condition.

The medication is used for managing conditions characterized by periods of heightened symptoms, specifically including acute psychotic episodes and chronic schizophrenic disorders. The medication is also applied in acute medical settings for the symptomatic relief of postoperative nausea and vomiting.

Managing Symptom Burdens and Functional Stability

This medication is commonly used during acute episodes to address symptom clusters that may become intense or disruptive, such as hallucinations, delusions, and disorganized thought patterns. It provides symptomatic relief that supports the management of these heightened manifestations, and may assist with maintaining functional stability during periods of crisis.

Solian is applied in the long-term management of chronic conditions to specifically address persistent negative symptoms, which include low motivation, emotional withdrawal, and apathy. This focus offers support that helps ease the impact of these deficits, may assist in easing the symptoms related to low energy, emotional responsiveness, and helps maintain a sense of stability when symptoms are more noticeable in daily life.

Quick Fact: Use in Acute Symptom Management

Property Description
Primary Domain Psychotic Spectrum Disorders
Core Symptom Type Positive and Negative Manifestations
Additional Use Postoperative Nausea and Vomiting (PONV)
Patient Benefit Contributes to maintaining functional stability and eases overall symptom burden

Regulatory References

  1. Amisulpride Mylan 400 mg film-coated Tablets - Summary of Product Characteristics

Eligibility and Restrictions for Use

The eligibility for Solian (Amisulpride) is strictly defined by government regulatory documents. Use is primarily established for adults (18 years and older).


Populations Who Must Not Use Solian (Contraindications)

The medicine is contraindicated and must not be used in several specific populations. These absolute exclusions include children up to puberty (under 15 years) and women who are breastfeeding (lactation). Use is also strictly forbidden in patients with known or suspected prolactin-dependent tumors (e.g., pituitary prolactinoma) or Phaeochromocytoma. Solian is further contraindicated when used concurrently with Levodopa or with certain medications that carry a risk of inducing Torsades de pointes.


Restricted or Conditional Use

Specific age groups and conditions require restricted or cautious use. Solian is generally not recommended for adolescents (puberty to 18 years) due to limited established safety data. Older adults should use the medicine with particular caution, and it is not licensed for those with dementia-related behavioral disturbances. Patients with renal impairment require restricted use and a mandatory dose reduction, particularly when creatinine clearance is between 10 and 60 mL/min. Use is not recommended during pregnancy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Solian (Amisulpride) defines interaction patterns primarily based on pharmacodynamic risk and the drug's elimination characteristics.

Contraindicated Combinations

Co-administration is strictly prohibited with medicinal products that pose a high pharmacodynamic risk of ventricular arrhythmias, specifically Torsades de pointes (TdP), due to an additive effect on the QTc interval. This category includes certain antiarrhythmics and specific neuroleptics. The product is also contraindicated with dopamine agonists such as Levodopa and non-antiparkinsonian agonists (e.g., Cabergoline, Quinagolide) due to a reciprocal antagonism of effects documented in regulatory labeling.

Interactions Requiring Caution

Caution is required when co-administering the drug with other Central Nervous System (CNS) depressants (e.g., benzodiazepines, sedative antidepressants). This combination carries the risk of additive depressant effects which may contribute to decreased alertness. Similarly, products known to induce hypokalemia or bradycardia increase the TdP risk and require caution according to official documents.

Exposure and Substance Notes

Use with alcohol is explicitly not recommended as it may enhance the central effects of the medicine. Due to the drug's primary renal elimination route, patients with severe renal dysfunction face an increased risk of accumulation. Regulatory-supported data notes that co-administration with Metformin can significantly increase Amisulpride exposure by inhibiting apparent clearance, a documented pharmacokinetic interaction.

Mechanism of Action

D2/ D3 Receptor Antagonism

The core mechanism involves highly selective antagonism—or blocking—of the Dopamine D2 and D3 receptors. This molecular action prevents the body's natural dopamine from fully engaging these specific receptor sites. This targeted interaction initiates the mechanistic cascade, which is focused predominantly on dopaminergic regulatory systems within the central nervous system.

Differential Dopamine Modulation

The drug exhibits a unique, concentration-dependent pattern of action. At lower concentrations, it preferentially blocks presynaptic autoreceptors, which functionally increases the release of dopamine into the synapse. At higher concentrations, it blocks the postsynaptic receptors, leading to a direct reduction of overactive signaling. This differential modulation results in the physiological consequence of enhancing dopamine release in hypoactive regions while reducing transmission in hyperactive regions.

Limbic Pathway Selectivity

Amisulpride shows functional regional selectivity, achieving the most significant receptor occupancy in the mesolimbic dopamine pathway, which is associated with thought and emotion processing. By minimizing binding in the nigrostriatal pathway (the motor control pathway), the mechanism limits the drug's functional consequence on the neural processes governing muscle tone and coordination.

Dosage and Administration Information

How to Use Solian (Amisulpride)

Solian is administered via different routes and dosing schedules depending on the specific use. The medication is primarily available in oral forms, such as tablets and oral solution, for long-term use. A sterile solution for injection is also used for specific short-term indications like managing postoperative nausea and vomiting (PONV).


Administration Routes and Frequency

The standard route for long-term management is oral intake. The frequency of administration is directly related to the total daily dose. For lower doses, typically up to 300 mg or 400 mg, the entire amount is usually administered once daily. When the dose exceeds this threshold, the total daily amount must be divided and taken in two separate doses. The injectable form is given as a single, acute intravenous (IV) dose, which is infused slowly over a period of 1 to 2 minutes.


Dosing Adjustments and Special Use

Specific dose adjustments are required for individuals with impaired renal function. For moderate impairment, the standard dose should be reduced to one-half, and for severe impairment, to one-third of the usual dose. No adjustment is generally necessary for individuals with hepatic impairment. Use of the medicine is not recommended in adolescents and is contraindicated in children younger than the age of puberty for the treatment of its primary indication. When long-term treatment is concluded, the medicine should be withdrawn gradually rather than abruptly.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Solian (Amisulpride)


Evidence for Managing Global Symptoms in Schizophrenic Disorders

The core body of research used to study the indication of this medicine includes numerous short- to medium-term, randomized controlled trials (RCTs). These studies were designed to rigorously compare the medicine against both a non-active comparator (placebo) and other established medications. The populations studied were typically adult patients experiencing conditions characterized by fluctuating or episodic manifestations, including periods of heightened symptom activity.

These research trials explored how overall symptom intensity changes over a defined time interval, with primary outcomes related to the monitoring of standardized symptom severity scores. Research examined measures related to both positive symptoms, such as delusions, and general psychopathology. Findings describe the patterns of how patients reported their experience during the study periods.


Focus on Predominantly Negative Symptoms

A distinctive aspect of the research landscape is the body of studies specifically focusing on conditions presenting with cycles of stability and flare-ups, where the research explored predominantly negative symptoms. These include challenges such as social withdrawal, apathy, and low motivation. The research examined the medicine in trials where patients had high burdens of these symptoms but low levels of positive symptoms.

These findings contribute to the description of symptom patterns in this studied subgroup. Nonetheless, studies focusing on this population typically have limited follow-up durations. While patterns were observed in short-term studies, certainty remains low regarding the maintenance of these effects over years. Research is ongoing to better characterize the sustained response in this specific patient group.


Research Evidence for Postoperative Nausea and Vomiting (PONV)

The medicine was evaluated in Phase III, multicenter, randomized controlled trials specifically for its use as an intravenous injection in an acute care setting. These studies examined temporary physiological imbalance following surgery, focusing on outcomes related to physical discomfort. The research included adult surgical patients identified as being at moderate-to-high risk for experiencing acute or disruptive episodes of nausea and vomiting after an operation.

Studies monitored patient-reported outcomes describing perceived discomfort. Data show patterns related to the Complete Response rates observed when the medicine was used both to prevent and to treat an acute episode of nausea, which were tracked against a placebo.


Evidence in Specific or Special Populations

The majority of the established evidence is derived from studies involving a broad group of adults with the studied conditions. Data for certain groups, such as the elderly population, remain insufficient in the primary RCTs for schizophrenic disorders. Similarly, evidence for pediatric patients or those with severe, complex medical comorbidities is generally lacking or is still emerging. Research has not fully established the evidence related to outcomes during pregnancy or breastfeeding, and data in these highly specialized circumstances remain limited.


Areas of Research Uncertainty and Gaps in Evidence

The evidence quality varies across studies, and certain types of comparative evidence are lacking, particularly head-to-head comparisons against the newest therapeutic options. Furthermore, subgroup findings are often uncertain; research describes group patterns and provides context, not individual predictions. Findings describe group patterns, not personal outcomes. The results apply only to the populations studied under specific research scenarios.

Frequently Asked Questions (FAQ)

Common questions about Solian (FAQ)

Q: What is the main condition Solian is approved to treat?

Official regulatory documents state that Solian (amisulpride) is primarily indicated for managing acute and chronic schizophrenic disorders. In some regions, an injectable form is also approved for preventing and treating postoperative nausea and vomiting (PONV).

Q: Is Solian the same as other medications used for psychosis?

Solian is classified as a second-generation, or atypical, antipsychotic medication, placing it in the same general class as many other drugs used for psychosis. However, it is noted for a highly selective mechanism of action that targets specific dopamine receptors in the brain.

Q: How quickly does Solian typically start working for new users?

According to clinical trial information, the time it takes for initial therapeutic effects to become noticeable can vary significantly between individuals. Research for its primary indication typically involves short- to medium-term studies, but there is no single established timeline for when all users will observe symptom changes.

Q: Is Solian considered a newer or older generation of its class of medicine?

Medical literature generally classifies Solian as a second-generation, or atypical, antipsychotic medication. This classification indicates a difference from older, 'typical' antipsychotics in terms of chemical structure and receptor selectivity.

Q: Why might a doctor switch a patient from another medicine to Solian?

Official documents highlight the drug’s specific activity as a highly selective blocker of certain dopamine receptors. This unique mechanism, along with specific research findings related to negative symptoms, helps distinguish it from some other available medications.

Q: Is Solian known to interact negatively with blood pressure medications?

Official product information advises caution when Solian is combined with any medication that slows the heart rate (bradycardia-inducing agents) or affects electrolyte balance, as these can increase the risk of serious heart rhythm problems. Additionally, regulatory documents mention a risk of orthostatic hypotension (a drop in blood pressure when standing).

Q: Are there any long-term effects of taking Solian that studies have identified?

The long-term use of Solian is associated with a risk of tardive dyskinesia, which involves involuntary movements, as described in official safety documents. Furthermore, cases of benign pituitary tumors have been observed, necessitating ongoing monitoring of prolactin levels.

Q: Can Solian be used by older adults?

According to official guidelines, the treatment of older adults (over 65) is generally not recommended. If use is necessary, particular caution is required due to increased susceptibility to side effects like sedation and low blood pressure (hypotension). Dose reduction may also be necessary if renal function is impaired.

Q: Can Solian impact liver function?

Official regulatory information notes that severe hepatotoxicity, or liver damage, has been reported in association with this drug. While no dose adjustment is typically needed for liver impairment alone, the risk of serious liver issues is a documented safety note.

Q: What information is available about Solian use during pregnancy?

Official guidance states that use during pregnancy is advised only when the potential benefit is judged to clearly outweigh the risk to the fetus. Neonates exposed during the third trimester are documented to be at risk for symptoms such as withdrawal or extrapyramidal movement issues.

Q: How does Solian differ from risperidone or olanzapine at a high level?

While classified as a second-generation antipsychotic like those drugs, Solian is distinguished by its highly selective binding to only the D2 and D3 dopamine receptors. This focused mechanism, particularly its selectivity for the limbic system, can result in different efficacy and side effect profiles compared to other agents.

Q: Do research studies show Solian is effective for the negative symptoms of schizophrenia?

Clinical studies have specifically examined the drug in patients who experience predominantly negative symptoms. Research describes patterns of observable improvement in these symptoms, particularly when using certain dose ranges. Official sources describe these findings as contributing to the understanding of symptom patterns in this subgroup.

Q: Can Solian cause issues with body temperature regulation?

Yes, official safety documents list the risk of Neuroleptic Malignant Syndrome (NMS), a rare but critical reaction. NMS is characterized by signs including hyperthermia (a dangerously high body temperature), severe muscle rigidity, and instability in automatic bodily functions.

Q: What official documents describe the proper conditions for using Solian?

The mandatory conditions for use, safety warnings, and patient guidance are detailed in documents issued by governmental authorities such as the Summary of Product Characteristics (SmPC) in Europe or the Consumer Medicine Information (CMI) in countries like Australia. These documents are the primary source of regulatory-approved information.

Q: Does Solian interact with common pain relievers like ibuprofen?

Specific interactions with common non-opioid pain relievers are typically not detailed in the core regulatory summaries. However, official sources advise caution with any medication that affects electrolyte balance, as this can elevate the risk of Torsades de pointes, a serious heart rhythm issue.

Q: Is Solian habit-forming or addictive?

Solian is not formally classified by regulatory bodies as a habit-forming or addictive substance. However, official guidance advises against abruptly stopping the medication, as a gradual withdrawal is recommended to prevent the return of original symptoms or the emergence of involuntary movement disorders.

Q: How often do people usually need checkups while on Solian?

Official product information mandates clinical monitoring for certain risks, such as checking heart rhythm (QT prolongation) and prolactin hormone levels, particularly when starting treatment or changing the dose. The exact schedule and frequency of follow-up visits are determined by a healthcare provider based on individual patient needs.

Q: Are there different strengths of Solian tablets available?

Yes, according to official product information, Solian tablets are available in several strengths, commonly including 50 mg, 100 mg, 200 mg, and 400 mg.

Q: What should a person do if they suspect an interaction with another drug while on Solian?

Official guidance provided in patient information leaflets consistently states that if an interaction is suspected, a person should contact their doctor or pharmacist immediately. Decisions regarding stopping or altering medication dosage should always be made in consultation with a healthcare professional.

Q: Is it true that Solian is not approved in certain countries?

Yes, the oral formulation of Solian for its primary psychiatric indication is not approved by regulatory bodies in the United States, although it is widely approved in Europe, Canada, and Australia. A different injectable formulation is approved in the US for specific acute care uses.

Q: What are the general expectations for the duration of Solian treatment?

For the treatment of schizophrenic disorders, regulatory documents and clinical practice indicate that treatment is typically long-term to help manage symptoms and prevent relapses. The exact duration is determined by the treating clinician based on the specific condition and the patient’s response.

Q: Does Solian affect blood sugar or cholesterol levels?

Official adverse reaction reports indicate that changes in metabolism are a documented risk. These changes can include elevated blood sugar (hyperglycaemia) and potential alterations in lipid profiles, such as increased levels of cholesterol or triglycerides.

Q: Are there official warnings about operating machinery while on Solian?

Yes, official warnings advise that Solian can cause side effects like drowsiness (somnolence), dizziness, or blurred vision. These effects may impair the ability to drive safely or operate potentially hazardous machinery, and regulatory guidance advises exercising caution.

Q: Is Solian typically taken with food or on an empty stomach?

Regulatory guidance describes that administration is preferably done before meals.

Q: How long does it take for Solian to leave the body after stopping?

The time it takes for a drug to be eliminated is often described by its half-life. Official pharmacological data indicates that the average elimination half-life for the drug is approximately 4 to 5 hours.

Q: What are the symptoms of an allergic reaction to Solian, according to official sources?

Official patient information lists signs of a potential allergic reaction, which is considered a medical emergency. These symptoms can include developing a rash, experiencing intense itching, shortness of breath, or swelling of the face, lips, throat, or tongue.

Q: Can Solian interact with herbal supplements like St. John's Wort?

While St. John’s Wort may not be specifically detailed in every interaction list, regulatory documents advise caution with medicines that alter the body’s drug-metabolizing processes. Because of the potential for unforeseen interactions, combining supplements with prescribed medication requires consultation with a healthcare professional.

Q: What does the term 'antipsychotic' mean in the context of Solian?

Antipsychotic is the specific class of medicine to which Solian belongs. These medications act by regulating key neurotransmitters in the brain, such as dopamine, to help manage the symptoms associated with certain psychiatric conditions.

Q: Is it common for people to take Solian for many years?

For the treatment of chronic conditions like schizophrenic disorders, regulatory documents and clinical guidelines indicate that long-term use is typical. Treatment is generally continued for many years to maintain symptom control and minimize the risk of a relapse.

Q: What evidence exists about Solian's impact on driving ability?

Official warnings state that the drug may cause effects such as drowsiness (somnolence) and blurred vision. This evidence forms the basis of the official guidance, which warns against certain activities, such as driving or operating complex machinery.

Q: Does Solian have a boxed warning, and if so, what is it about?

Solian is part of a class of medications called atypical antipsychotics. While the specific oral formulation may not have a US Boxed Warning, this drug class generally carries a critical warning regarding an increased risk of death when used to treat older adults with dementia-related psychosis.

Q: What is the regulatory status of Solian in Europe versus the US?

Solian (oral amisulpride) has widespread regulatory approval for its psychiatric uses across Europe, Canada, and Australia. In contrast, the US Food and Drug Administration (FDA) has only approved an intravenous formulation for a non-psychiatric indication (postoperative nausea and vomiting).

Q: What does official information say about Solian and eye health?

Official regulatory adverse reaction reports include blurred vision as a possible side effect of the medicine.

Q: Is it normal to have vivid dreams or nightmares when taking Solian?

Official product information lists general nervous system side effects such as insomnia and anxiety, which relate to sleep quality. While specific mentions of vivid dreams or nightmares are not consistently found in the core label, these effects are related to the drug's general impact on sleep and alertness.

Q: Does the time of day matter when taking Solian?

For patients taking the medication once daily, official guidance often includes the suggestion of administration in the evening or at bedtime. This suggestion is offered to help mitigate potential daytime drowsiness or sedation, which is a common side effect.

Q: What happens if a dose of Solian is missed?

Patient information leaflets often contain guidance that if a dose is missed, the recommended action is to take it as soon as it is remembered. If the time is near the next scheduled dose, the guidance often recommends skipping the missed dose and continuing with the regular regimen, avoiding the consumption of a double dose.

Q: What is the connection between Solian and prolactin levels?

Solian can cause an increase in the hormone prolactin in the blood. This effect can lead to side effects like breast-related disorders, changes in menstruation, or sexual dysfunction, as described in official safety documents.

How should Solian be stored and disposed of?

Official Storage and Disposal Requirements

Storage of Solian (amisulpride) tablets is subject to specific regulatory requirements to ensure product stability. The medicine must be kept in its original package (blister pack and carton) and stored at a temperature below 25°C or 30°C, depending on the licensed formulation. Storage must protect the tablets from moisture and heat; they should not be stored in humid areas like bathrooms or left in hot environments. Solian must be stored out of the sight and reach of children as a mandatory safety measure.

Regarding disposal, regulatory labeling strictly mandates that unused or expired Solian must not be discarded via household waste or wastewater. Individuals are required to ask a pharmacist for guidance on proper disposal according to local pharmaceutical waste regulations.

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

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