Summary
Abilify® (aripiprazole) is an atypical antipsychotic available as oral tablets in strengths of 2, 5, 10, 15, 20, and 30 mg for once‑daily dosing . It acts as a “dopamine‑serotonin stabilizer,” functioning as a partial agonist at dopamine D₂/D₃ and serotonin 5‑HT₁A receptors, and as an antagonist at serotonin 5‑HT₂A receptors . Abilify is FDA‑approved for schizophrenia, acute and maintenance treatment of bipolar I disorder, adjunctive therapy for major depressive disorder, irritability in autism spectrum disorder, and Tourette’s disorder . Typical adult dosing ranges from 10 mg to 30 mg once daily, with lower starting doses (2–5 mg) in pediatric and adjunctive depression settings . Common adverse effects include akathisia, insomnia, nausea, and constipation; serious risks encompass neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, and orthostatic hypotension . Tablets should be stored at 20–25 °C, protected from moisture and light .
Composition & Mechanism of Action
Active & Inactive Ingredients
Active: Aripiprazole USP, available in tablets of 2, 5, 10, 15, 20, or 30 mg .
Inactive: Excipients include microcrystalline cellulose, magnesium stearate, croscarmellose sodium, tartaric acid, and colorants (ferric oxides, FD&C Blue No. 2) .
Pharmacodynamics
Dopamine D₂/D₃ Partial Agonism: Modulates dopaminergic tone—stimulating when dopamine is low and blocking when high .
Serotonin 5‑HT₁A Partial Agonism: Contributes to anxiolytic and antidepressant effects .
Serotonin 5‑HT₂A Antagonism: Mitigates psychotic symptoms and reduces extrapyramidal side effects compared to typical antipsychotics .
Inverse Agonism at 5‑HT₂B & Partial Agonism at 5‑HT₂C: May underlie weight‑neutral profile and cardiovascular safety .
Indications
Schizophrenia in adults and adolescents (≥ 13 years) .
Bipolar I Disorder: Acute manic/mixed episodes and maintenance, in adults and pediatric patients (10–17 years) .
Major Depressive Disorder (Adjunctive): With antidepressants in adults with inadequate response .
Irritability in Autism Spectrum Disorder: Pediatric patients 6–17 years .
Tourette’s Disorder: Management of tics in children and adolescents .
Dosage & Administration
Tablet Formulation
Administration: Swallow tablets whole, with or without food .
Titration: Adjust by ≤ 5 mg increments at ≥ 1 week intervals .
Special Populations: Reduce dose by 50 % in CYP2D6 poor metabolizers and when co‑administered with CYP3A4 inhibitors .
Adverse Effects & Warnings
Common
Akathisia, insomnia, headache, nausea, vomiting, constipation, anxiety, restlessness .
Serious
Neuroleptic malignant syndrome, tardive dyskinesia, cerebrovascular events in dementia, orthostatic hypotension, leukopenia, metabolic changes (hyperglycemia, dyslipidemia, weight gain) .
Boxed Warnings
Increased mortality in elderly with dementia‑related psychosis; increased risk of suicidal thoughts and behaviors in children/adolescents .
Contraindications
Hypersensitivity to aripiprazole; use during dementia‑related psychosis .
Storage & Handling
Store tablets at 20–25 °C (68–77 °F), with permitted excursions of 15–30 °C; protect from moisture and light .
Keep out of reach of children.
Availability & Pricing
Manufacturer: Otsuka Pharmaceutical Co., Ltd.; distributed in the U.S. by Otsuka America Pharmaceutical, Inc. .
Packaging: Bottles or blister packs of 30 tablets per strength.
Cost (U.S. Average Wholesale Price): Approximately USD 1,200–1,500 for a 30‑day supply of 15 mg tablets (varies by insurer and pharmacy).
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References
DailyMed: ARIPIPRAZOLE tablet prescribing information
FDA AccessData: ABILIFY prescribing label
Drugs.com: Abilify uses and side effects
Mayo Clinic: Aripiprazole oral route description
RxLi
st: Abilify (aripiprazole) drug overview
Drugs.com Medical Q&A: Aripiprazole receptor activity