Last reviewed 2026-04-20 · How we verify

Invega Sustenna (PALIPERIDONE PALMITATE)

Invega Sustenna works by blocking a specific channel in the brain that helps regulate electrical activity.

Invega Sustenna (paliperidone palmitate) is a long-acting atypical antipsychotic medication developed by Janssen Pharmaceuticals. It targets the potassium voltage-gated channel subfamily H member 2 to treat schizophrenia. Originally approved by the FDA in 2009, Invega Sustenna is a patented medication with no generic manufacturers available. As an atypical antipsychotic, it is used to manage symptoms of schizophrenia, but its use requires careful consideration of potential side effects. Key safety considerations include the risk of extrapyramidal symptoms, hyperprolactinemia, and QT interval prolongation.

At a glance

Mechanism of action

Paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3)]. Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unclear. However, the drugs therapeutic effect in schizophrenia could be mediated through combination of central dopamine Type (D2) and serotonin Type (5HT2A) receptor antagonism.

Approved indications

• Schizophrenia

Boxed warnings

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA SUSTENNA is not approved for use in patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA SUSTENNA is not approved for use in patients with dementia-related psychosis. ( 5.1 )

Common side effects

• Injection site reactions
• Somnolence/sedation
• Dizziness
• Akathisia
• Extrapyramidal disorder
• Weight increased
• Nasopharyngitis
• Headache
• Hyperprolactinemia
• Pyrexia
• Fatigue
• Nausea

Drug interactions

• Drugs that may cause orthostatic hypotension
• Strong CYP3A4/P-glycoprotein (P-gp) inducers (e.g., carbamazepine, rifampin, St John's Wort)
• Centrally Acting Drugs and Alcohol
• Levodopa and Other Dopamine Agonists

Key clinical trials

• Substance Misuse To Psychosis for Stimulants (PHASE2,PHASE3)
• A Bioequivalence Study of PP3M in Patients With Schizophrenia (NA)
• An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
• Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
• Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
• Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia (NA)
• Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia (PHASE4)
• Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Invega Sustenna CI brief — competitive landscape report
• Invega Sustenna updates RSS · CI watch RSS
• Johnson & Johnson portfolio CI