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aripiprazole

AntipsychoticLAI available

Brands: ABILIFY

Last reviewed 2025-12-28

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is aripiprazole?

    Aripiprazole (Abilify; oral and several long-acting injectable forms) is a second-generation antipsychotic. See the compare view versus risperidone and quetiapine for a quick risk snapshot.

  • What is ABILIFY?

    ABILIFY is a brand name for aripiprazole.

  • What is ABILIFY (aripiprazole) used for?

    Label indications include: Schizophrenia; acute manic or mixed episodes of bipolar I disorder (monotherapy or adjunct to lithium/valproate); maintenance therapy via LAI formulations; adjunctive treatment of major depressive disorder; irritability in autistic disorder; Tourette disorder.

  • What drug class is ABILIFY (aripiprazole)?

    Antipsychotic.

  • What is the mechanism of action of ABILIFY (aripiprazole)?

    Dopamine D2/D3 partial agonist with 5-HT1A partial agonism and 5-HT2A antagonism, stabilizing dopaminergic tone with comparatively low metabolic and EPS burden.

  • What strengths does ABILIFY (aripiprazole) come in?

    Oral tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg.

  • Is ABILIFY (aripiprazole) a controlled substance?

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

  • What is ABILIFY (aripiprazole) dosing for schizophrenia?

    Schizophrenia (adults): start 10–15 mg once daily; therapeutic range 10–30 mg/day. Doses above 30 mg rarely add benefit.

  • How is aripiprazole started as a long-acting injectable (LAI)?

    Long-acting injectables (LAI): Abilify Maintena (300 mg, 400 mg monthly), Abilify Asimtufii (720 mg, 960 mg every two months), Aristada (441 mg, 662 mg, 882 mg monthly; 1064 mg every two months; 720 mg every six weeks) with Aristada Initio loading option.

Snapshot

  • Class: Antipsychotic
  • Common US brands: ABILIFY
  • Long-acting injectable formulation available.
  • Therapeutic drug monitoring not routinely recommended; reference range 120–270 ng/mL.
  • Last reviewed: 2025-12-28

Label indications

Schizophrenia; acute manic or mixed episodes of bipolar I disorder (monotherapy or adjunct to lithium/valproate); maintenance therapy via LAI formulations; adjunctive treatment of major depressive disorder; irritability in autistic disorder; Tourette disorder.

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Clinical Highlights

Aripiprazole (Abilify; oral and several long-acting injectable forms) is a second-generation antipsychotic. See the compare view versus risperidone and quetiapine for a quick risk snapshot. This profile focuses on serious mental illness uses: schizophrenia and bipolar I disorder (acute manic or mixed episodes), with LAI maintenance options. Review the aripiprazole evidence feed when considering dose changes or depot conversions.

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  • Aripiprazole is often chosen when sedation, weight gain, or prolactin elevation are concerns, but akathisia/restlessness and insomnia can be limiting.
  • Schizophrenia (adults) (FDA 2002)
  • Schizophrenia (adolescents ≥13 years) (FDA 2006)
  • Acute manic or mixed episodes in bipolar I disorder (monotherapy) (FDA 2004)

Dosing & Formulations

Oral tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg. Orally disintegrating tablets: 10 mg, 15 mg.

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  • Oral solution: 1 mg/mL.
  • Short-acting intramuscular injection for agitation: 9.75 mg/1.3 mL vial.
  • Long-acting injectables (LAI): Abilify Maintena (300 mg, 400 mg monthly), Abilify Asimtufii (720 mg, 960 mg every two months), Aristada (441 mg, 662 mg, 882 mg monthly; 1064 mg every two months; 720 mg every six weeks) with Aristada Initio loading option.
  • Schizophrenia (adults): start 10–15 mg once daily; therapeutic range 10–30 mg/day. Doses above 30 mg rarely add benefit.

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 when used as an antidepressant adjunct (shared antidepressant class warning).

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  • Akathisia/restlessness: Up to 16% in oral trials; 11% vs 4% placebo with Abilify Maintena. Most frequent reason for discontinuation.
  • Insomnia: Reported in up to 17% of patients.
  • Anxiety: As high as 17% in some studies.
  • Nausea: Approximately 10–12% of adults.
  • Short-term metabolic signal: a 7-week double-blind trial reported smaller BMI increases with aripiprazole than risperidone; decreased appetite was more common with aripiprazole; asking about appetite early can be a practical marker.
  • Long-term switching data: an 18-month EULAST follow-up found ~4–5 kg mean weight gain after switching to aripiprazole or paliperidone and no metabolic advantage for LAIs; routine metabolic monitoring remains important.

Drug Interactions

Strong CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine) increase exposure—reduce oral dose by 50% and adjust LAI schedules per labeling. Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, itraconazole) increase exposure—reduce dose by 50%.

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  • Strong CYP3A4 inducers (carbamazepine, rifampin, St. John’s wort) markedly reduce exposure—double oral dose or avoid; LAIs are generally contraindicated with strong inducers.
  • Additive CNS depression with alcohol, benzodiazepines, or opioids.
  • Caution with antihypertensives or α1 blockers due to orthostatic hypotension risk.
  • Monitor QTc when combining with other QT-prolonging medications, though aripiprazole itself has low QT liability.

Practice Notes

Long elimination half-life supports once-daily dosing and aids adherence, and smoking does not meaningfully affect levels (no CYP1A2 pathway). Abilify Maintena requires 14-day oral supplementation after the first injection; Asimtufii combines a one-time 20 mg oral dose with the first injection—consult the LAI Navigator for depot intervals and overlap logistics.

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  • Aristada uses aripiprazole lauroxil with Aristada Initio or 21-day oral overlap; align relapse-prevention planning with the schizophrenia hub and bipolar disorder hub when pairing lithium or valproate.
  • Akathisia can emerge in the first month; beta-blockers or dose adjustments are often considered, and the contrast view can help when weighing alternative partial agonists.
  • Patients and caregivers should be informed about impulse-control warnings. Printable counseling sheets are available in the aripiprazole print view, and condition hubs can support shared decision-making.

Long-acting injectable (LAI) options

  • Aripiprazole monohydrate (Abilify Maintena)
    Interval
    Monthly (q4wk)
    Oral overlap
    Yes — typically 14 days
    Injection site
    Deltoid or gluteal
    Notes
    • Consider 2‑week oral overlap after first injection
  • Aripiprazole lauroxil (Aristada/Aristada Initio)
    Interval
    q4–8wk (varies by strength)
    Oral overlap
    Yes — typically 21 days (unless using Initio loading)
    Injection site
    Deltoid or gluteal
    Notes
    • Initio option available for loading; see label
  • Interval
    Every 2 months (q8wk)
    Oral overlap
    Yes — 14-day oral overlap or 1-day init regimen (see label)
    Injection site
    Gluteal
    Notes
    • Confirm CYP2D6/CYP3A4 dose adjustments before starting

References

  1. ABILIFY (aripiprazole) tablets and injection — Prescribing Information — DailyMed (2025)
  2. Abilify Maintena (aripiprazole) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
  3. Abilify Asimtufii (aripiprazole) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
  4. Aristada (aripiprazole Lauroxil) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
  5. WHO EML 2023 Aripiprazole
  6. Skyquest2022 Antipsychotic Market
  7. Aripiprazole maintenance study in recently manic bipolar I patients — Journal of Clinical Psychiatry (2006)
  8. Safety OF Once Monthly Aripiprazole Initiation IN Schizophrenia — Current Medical Research and Opinion (2013)
  9. Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017 — Pharmacopsychiatry (2018)
  10. FDA NDA 021436
  11. Assessing THE Metabolic Impact OF Aripiprazole Versus Risperidone IN THE Treatment OF Schizophrenia: A Randomized Double Blind Controlled Clinical Trial — BMC Psychiatry (2025)
  12. THE Effect OF Switching Antipsychotics TO Aripiprazole Versus Paliperidone ON Weight/cardiometabolic Parameters: 18 Month Follow UP Findings From THE European Long Acting Antipsychotics IN Schizophrenia Trial (eulast) — Eur Neuropsychopharmacol (2026)
Aripiprazole (ABILIFY) — Summary — PsychMed