aripiprazole
Brands: ABILIFY
Last reviewed 2025-12-28
Reviewed by PsychMed Editorial Team.
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.
View labelExactClinical 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
- ABILIFY (aripiprazole) tablets and injection — Prescribing Information — DailyMed (2025)
- Abilify Maintena (aripiprazole) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
- Abilify Asimtufii (aripiprazole) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
- Aristada (aripiprazole Lauroxil) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
- WHO EML 2023 Aripiprazole
- Skyquest2022 Antipsychotic Market
- Aripiprazole maintenance study in recently manic bipolar I patients — Journal of Clinical Psychiatry (2006)
- Safety OF Once Monthly Aripiprazole Initiation IN Schizophrenia — Current Medical Research and Opinion (2013)
- Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017 — Pharmacopsychiatry (2018)
- FDA NDA 021436
- Assessing THE Metabolic Impact OF Aripiprazole Versus Risperidone IN THE Treatment OF Schizophrenia: A Randomized Double Blind Controlled Clinical Trial — BMC Psychiatry (2025)
- 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)
