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cariprazine

Antipsychotic

Brands: VRAYLAR

Last reviewed 2026-02-12

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is cariprazine?

    Cariprazine (brand Vraylar) is an second-generation antipsychotic (SGA) that preferentially targets dopamine D3 receptors, supporting efficacy across schizophrenia and bipolar disorder mood states.

  • What is VRAYLAR?

    VRAYLAR is a brand name for cariprazine.

  • What is VRAYLAR (cariprazine) used for?

    Label indications include: Schizophrenia; acute treatment of manic or mixed episodes and depressive episodes associated with bipolar I disorder; adjunctive therapy to antidepressants for major depressive disorder.

  • What drug class is VRAYLAR (cariprazine)?

    Antipsychotic.

  • What is the mechanism of action of VRAYLAR (cariprazine)?

    D3/D2 partial agonist (D3‑preferring); 5‑HT1A partial agonist; 5‑HT2A antagonist.

  • What strengths does VRAYLAR (cariprazine) come in?

    Oral capsules (cariprazine hydrochloride / cariprazine HCl): 1.5 mg, 3 mg, 4.5 mg, 6 mg; blister and bottle packaging.

  • Is VRAYLAR (cariprazine) a controlled substance?

    No — it is not scheduled as a controlled substance under U.S. federal law.

  • What is VRAYLAR (cariprazine) dosing for schizophrenia?

    Schizophrenia: start 1.5 mg once daily; increase to 3 mg on day 2; adjust by 1.5–3 mg increments at ≥2-week intervals to 1.5–6 mg/day (max 6 mg).

  • What is the maximum dose of VRAYLAR (cariprazine) for major depressive disorder (clinical depression)?

    Adjunctive major depressive disorder (clinical depression): start 1.5 mg once daily with an antidepressant; may increase to 3 mg/day (max 3 mg/day).

  • What is cariprazine hydrochloride (HCl)?

    Oral capsules (cariprazine hydrochloride / cariprazine HCl): 1.5 mg, 3 mg, 4.5 mg, 6 mg; blister and bottle packaging.

Snapshot

  • Class: Antipsychotic
  • Common US brands: VRAYLAR
  • Therapeutic drug monitoring not routinely recommended.
  • Last reviewed: 2026-02-12

Label indications

Schizophrenia; acute treatment of manic or mixed episodes and depressive episodes associated with bipolar I disorder; adjunctive therapy to antidepressants for major depressive disorder.

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Clinical Highlights

Cariprazine (brand Vraylar) is an second-generation antipsychotic (SGA) that preferentially targets dopamine D3 receptors, supporting efficacy across schizophrenia and bipolar disorder mood states. This profile emphasizes its role in schizophrenia, bipolar I mania/mixed episodes, bipolar depression, and adjunctive major depressive disorder (MDD; clinical depression) as add-on therapy to antidepressants.

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  • Cariprazine mechanism of action combines D3/D2 partial agonism with 5-HT1A partial agonism and 5-HT2A antagonism, making it a close comparator to aripiprazole and brexpiprazole while offering stronger D3 affinity.
  • Clinicians leverage cariprazine for negative-symptom improvement and bipolar depression coverage. Long-lived metabolites demand slow titration and careful monitoring for akathisia and GI upset; metabolic impact is moderate.
  • The compare view, the cariprazine evidence feed, and the cariprazine print page can support shared decision-making and counseling; the schizophrenia hub and bipolar disorder hub link to broader care pathways.
  • Schizophrenia (adults) (FDA 2015)
  • Bipolar I manic/mixed episodes (adults) (FDA 2015)
  • Bipolar I depression (adults) (FDA 2019)

Dosing & Formulations

Oral capsules (cariprazine hydrochloride / cariprazine HCl): 1.5 mg, 3 mg, 4.5 mg, 6 mg; blister and bottle packaging. Schizophrenia: start 1.5 mg once daily; increase to 3 mg on day 2; adjust by 1.5–3 mg increments at ≥2-week intervals to 1.5–6 mg/day (max 6 mg).

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  • Bipolar I mania/mixed: initiate 1.5 mg once daily, increase to 3 mg on day 2, then titrate by 1.5 mg increments up to 6 mg/day.
  • Bipolar I depression: 1.5 mg once daily for at least 14 days; may increase to 3 mg/day based on response.
  • Adjunctive major depressive disorder (clinical depression): start 1.5 mg once daily with an antidepressant; may increase to 3 mg/day (max 3 mg/day).
  • Label recommends halving the dose with strong CYP3A4 inhibitors; coadministration with strong CYP3A4 inducers is generally avoided; not recommended in severe hepatic impairment.
  • Long effective half-life (up to 1–3 weeks for metabolites) means dose changes or missed doses manifest gradually; waiting several weeks before further adjustments is common.

Monitoring & Risks

Boxed warning: Increased mortality in elderly patients with dementia-related psychosis (antipsychotic class warning). Boxed warning: Suicidal thoughts and behaviors in children, adolescents, and young adults treated with antidepressants (applies to adjunctive MDD indication).

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  • Akathisia: Occurs in up to 20% depending on dose; most frequent cause of discontinuation.
  • Extrapyramidal symptoms (EPS): Overall 6–10%, predominantly akathisia and tremor.
  • Nausea: Approximately 10% of patients.
  • Somnolence: Around 10% across indications.

Drug Interactions

Strong CYP3A4 inhibitors (ketoconazole, clarithromycin) increase exposure; label recommends reducing cariprazine dose by half and monitoring for akathisia or sedation. Strong CYP3A4 inducers (rifampin, carbamazepine, St. John’s wort) substantially lower exposure; coadministration is generally avoided.

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  • Moderate CYP3A4 inhibitors often warrant slower titration and closer monitoring.
  • Additive CNS depression with alcohol, benzodiazepines, or opioids.
  • May blunt efficacy of dopamine agonists (e.g., levodopa); this combination is often avoided when dopaminergic therapy is needed.

Practice Notes

Long-lived metabolites mean clinical response to dose changes can be delayed; allowing several weeks before adjusting again is common. Patients and caregivers can be advised on early akathisia; clinicians often manage it with dose adjustments, beta-blockers, or benzodiazepines.

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  • Low impact on QTc, but a baseline ECG is often considered in patients with cardiac risk or polypharmacy.
  • Once-daily dosing at a consistent time (with or without food) helps maintain steady exposure.
  • Metabolic monitoring typically includes baseline, 12 weeks, then annually.
  • Comparing dopamine partial agonists via the compare view can help tailor negative-symptom or bipolar depression strategies.

References

  1. VRAYLAR (cariprazine) prescribing information — DailyMed (2025)
  2. FDA Vraylar Medr 2015
  3. Cariprazine IN Acute Exacerbation OF Schizophrenia: A Randomized, Double Blind, Placebo Controlled Trial — Schizophrenia Research (2015)
  4. Nemeth2017 Cariprazine Negative
  5. AN 8 Week Randomized, Double Blind, Placebo Controlled Evaluation OF Cariprazine IN Bipolar I Depression — American Journal of Psychiatry (2016)
  6. Efficacy OF Adjunctive LOW Dose Cariprazine IN Major Depressive Disorder — International Clinical Psychopharmacology (2018)
Cariprazine (VRAYLAR) — Summary — PsychMed