Text Size :
A A A

Amisulpride

Brands and Forms

  • Solian
    • tablet: 50mg, 100mg, 200mg, 400mg
    • liquid: 100mg/ml

Uses of Amisulpride

Amisulpride can be used in the treatment of Psychotic Disorders, Bipolar Disorder, Depressive Disorders, PTSD, and OCD.

Amisulpride can also be used in the management of behavioral disturbances, such as agitation and impulsivity, that can occur in various conditions like Impulse-Control Disorders, Disruptive Behavior Disorders, and Borderline Personality Disorder.

How Amisulpride Works

Amisulpride is an Atypical Antipsychotic. It is an antagonist at dopamine D2 and D3 receptors, a GHB receptor agonist, and an antagonist at serotonin 5HT7 receptors. In terms of its dopaminergic actions, at low doses (50-200mg) it preferentially blocks dopamine inhibitory presynaptic receptors, which thus increases overall dopamine neurotransmission; at higher doses it reduces dopamine neurotransmission.

Cautions when Using Amisulpride

In elderly individuals with Dementia, use of Antipsychotics has been associated with increased rates of sudden death. It is unclear whether the antipsychotic use is a cause, or simply a marker, of deteriorating health in these individuals.

Individuals with Parkinson disease or Lewy-Body Dementia may have increased sensitivity to Amisulpride, which may manifest as confusion, obtundation, severe extrapyramidal symptoms, and neuroleptic malignant syndrome.

QTc prolongation (which can lead to heart arrhythmias) can occur at higher doses (>800mg/day). In patients with known heart disease, advice from a cardiologist should be obtained before starting Amisulpride.

In patients with pheochromocytoma, prolactin-secreting tumors, or a seizure disorder, advice from the appropriate medical specialist should be obtained before using Amisulpride.

Dosing of Amisulpride

Doses below 400mg a day can be given once daily, while doses above 400mg a day should be divided twice daily. The maximum dose is generally 1200mg/day.

For Depressive Disorders, 50mg a day is optimal.

When targeting negative symptoms of Schizophrenia, doses of 50-300mg a day are recommended.

For the positive symptoms of Schizophrenia, the target dose range is 400-800mg/day, and the medication can be started right away at these doses.

For all other uses, Amisulpride should be started in the lower dose range and then increased progressively as required.

When wanting to stop Amisulpride, the dose should be decreased gradually over a period of 6-8 weeks.

Onset of action

In Schizophrenia, psychotic symptoms can improve within 1 week of use, but full therapeutic effect may take several weeks. If there is no significant effect after 4-6 weeks then it may not work at all.

Acute agitation can improve after a single dose.

For other conditions, 4-6 weeks may be needed to see a therapeutic effect.

Kidney impairment

Dose should be reduced to half in patients with creatinine clearance between 30-60ml/min, and to a third in patients with creatinine clearance between 10-30ml/min. Particular care is recommended for patients with severe kidney impairment.

Liver impairment

Dose reduction not necessary.

Side-effects of Amisulpride

Below is a list of most of the reported side-effects of Amisulpride. Most of these side-effects occur in only a minority of individuals, and many also resolve with time while the medication is continued.

Cardiovascular: increased or decreased blood pressure; QTc prolongation (rare).

Central Nervous System: headache; somnolence; extrapyramidal symptoms; insomnia; tremor; dizziness; seizures (rare).

Dermatologic: rash; excessive perspiration.

Endocrine: Weight gain; metabolic syndrome (insulin resistance, elevated blood sugars, hyperlipidemia and hypercholesterolemia); elevated prolactin; breast pain, enlargement, or milk production in men and women; trouble conceiving; loss of libido; erectile dysfunction.

Eyes, Ears, Nose and Throat: blurred vision; dry mouth.

Gastrointestinal: nausea; constipation; vomiting.

Musculoskeletal: muscle stiffness; muscle pains; muscle spasms; neuroleptic malignant syndrome (rare).

Psychiatric: anxiety; agitation; obsessive-compulsive symptoms.

Respiratory: aspiration pneumonia (due to esophageal dysmotility; rare).

Common side-effects of Amisulpride

Sedation, fatigue, insomnia, constipation, weight gain.

Rare but serious side-effects of note of Amisulpride

  • neuroleptic malignant syndrome
  • serious cardiac arrhythmias can result if QTc prolongation occurs (electrocariograms are therefore required to monitor for heart rhythm changes).
  • increased risk of sudden death in elderly individuals with Dementia.

Amisulpride overdose

Sedation, low blood pressure, extrapyramidal symptoms, coma.

Amisulpride and pregnancy

Animal studies have not shown any adverse effects, but no controlled human studies have been done; can be used in pregnancy if benefits outweigh potential risks.

Amisulpride, weight gain and metabolic syndrome

A small percentage of people taking Amisulpride will gain about 7% of their total body weight within 8 weeks of starting the medication [ref, ref]. Metabolic side-effects, including elevated glucose and lipids can also occur, which in the long-term increase the risk for heart disease and vascular problem.

See here for further information on these side-effects, and how they can be managed.

Medical Monitoring for Amisulpride

Monitoring for weight gain and a metabolic syndrome requires the following measures to be taken prior to starting the medication, then monthly for the first 3 months of use, and then every 3 months:

  • Body Mass Index (BMI)
  • waistline circumference at umbilicus
  • blood pressure
  • fasting blood glucose
  • fasting blood lipids and cholesterol

To monitor for elevated prolactin, prolactin levels should be measured prior to starting the medication, and then one month after every dose increase.

To monitor for QTc prolongation, an electrocardiogram should be performed prior to starting the medication, and then one month after every dose increase.

Drug Interactions with Amisulpride

  • Combination with the following medications is contraindicated due to the high risk of QTc prolongation and torsades de pointes:
    • Class Ia antiarrhythmic agents such as Quinidine, Disopyramide, Procainamide
    • Class II antiarrhythmics such as Amiodarone and Sotalol
    • Other medications, including Bepridil, Cisapride, Sultopride, Thioridazine, Methdone, IV Erythromycin, IV Vincamine, Halofantrine, Pentamidine, Sparfloxacin.
  • Combination with the following medications should be done with caution due to increased risk of QTc prolongation and torsades de pointes:
    • Pimozide, Haloperidol, Ziprasidone, Lithium.
    • Bradycardia-inducing medications such as beta-blockers, Diltiazem, Verapamil, Clonidine, Guanfacine, Digitalis
    • Medications that induce hypokalemia or electrolyte imbalance such as hypokalemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides.