Aripiprazole
Aripiprazole
Abilify (oral), Abilify Maintena (monthly IM LAI), Aristada (aripiprazole lauroxil IM LAI), Abilify Asimtufii (bi-monthly IM LAI), Abilify MyCite (digital ingestion sensor)
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Summary
Common uses
Schizophrenia (FDA, ages 13+)0, Bipolar mania and mixed episodes (FDA)0, Bipolar maintenance (FDA)0, Major depressive disorder adjunct (FDA)0, Autism spectrum disorder-associated irritability (FDA, pediatric ages 6-17)0, Tourette syndrome (FDA, pediatric)0
Pharmacy
Starting dose
Schizophrenia/bipolar mania: 10-15 mg PO once daily, target 15-30 mg. MDD adjunct: 2-5 mg/day, target 5-15 mg. Pediatric autism irritability: 2 mg, titrate to 5-15 mg. Maintena LAI: 400 mg IM every 4 weeks after oral overlap
Preparations
Tablets 2, 5, 10, 15, 20, 30 mg; ODT 10, 15 mg; oral solution 1 mg/mL; acute IM injection 9.75 mg/1.3 mL; Maintena LAI 300, 400 mg monthly; Aristada LAI 441, 662, 882, 1064 mg (4-8 week dosing); Asimtufii bi-monthly
US FDA Max
30 mg/day (adult schizophrenia); 15 mg/day (MDD adjunct)
Pharmacology
Routes
Oral, intramuscular (acute and long-acting)
Onset
Neuroleptic effect emerges over days to weeks; activation symptoms (akathisia, insomnia) often within days
Duration
24 hours (oral); 4-8 weeks (LAI)
Half-life
~75 hours (long, accumulates over weeks)[1]
Bioavailability
~87% (oral)[1]
Pregnancy
Limited human data; signal for neonatal extrapyramidal symptoms and withdrawal with third-trimester exposure.[citation needed]
Legal status
Purported mechanism
D2 and D3 dopamine receptor partial agonist (the third-generation neuroleptic signature, distinct from olanzapine/risperidone full D2 antagonism), with additional 5-HT1A partial agonism and 5-HT2A receptor antagonism. The D2 partial agonism is the "dopamine system stabilizer" rationale: in hyperdopaminergic states (psychosis, mania) aripiprazole functions as a partial antagonist; in hypodopaminergic states (prefrontal cortex, MDD adjunct) it functions as a partial agonist.0 Akathisia is the most common dose-limiting adverse effect, particularly with the MDD-adjunct dose range. Lower weight gain, lower metabolic burden, and lower prolactin elevation than most second-generation neuroleptics, the principal pharmacological selling points. CYP2D6 and CYP3A4 metabolism; CPIC PGx guidance applies for CYP2D6 dose individualization[1].
References
- ↑ 1.0 1.1 1.2 1.3 FDA Prescribing Information, Abilify (aripiprazole), Otsuka/Bristol-Myers Squibb, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf