What is Abilify (aripiprazole) used for?

Approved Uses of Abilify (Aripiprazole)

Abilify (aripiprazole) is FDA-approved for the treatment of schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder. 1, 2

Primary FDA-Approved Indications

• Schizophrenia: Approved for both adults and pediatric patients (13-17 years) for the treatment of schizophrenia, with demonstrated efficacy in reducing positive and negative symptoms 1, 3
• Bipolar I Disorder:
  • Approved for acute and maintenance treatment of manic and mixed episodes 1
  • Can be used as monotherapy or as adjunctive therapy with lithium or valproate 1
  • Approved for adolescents (≥13 years) with moderate to severe manic episodes at a recommended dose of 10 mg daily for 12 weeks 4
• Major Depressive Disorder: Approved as an adjunctive therapy to antidepressants for treating major depressive disorder in adults who have had an inadequate response to antidepressant therapy alone 2

Dosing Considerations

• For schizophrenia in adults, the recommended starting and target dose is 10-15 mg/day, with demonstrated efficacy as early as the first or second week of treatment 1, 3
• For pediatric patients (13-17 years) with schizophrenia, the recommended dose is 10 mg/day, with no additional benefit shown at higher doses 1
• For bipolar disorder maintenance, aripiprazole has demonstrated superiority to placebo in preventing relapse of both manic and depressive episodes 1
• No dosage titration is necessary for most patients, which simplifies administration 3

Pharmacological Properties

• Aripiprazole has a unique mechanism of action as a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, while acting as an antagonist at 5-HT2A receptors 5, 3
• This distinctive pharmacological profile contributes to its efficacy for positive and negative symptoms of schizophrenia while having a lower propensity for extrapyramidal symptoms compared to typical antipsychotics 3

Off-Label Uses

• May be used at doses of 5 mg orally or intramuscularly for the management of delirium in adult cancer patients, particularly when less sedation is desired 6
• Has been studied for maintaining abstinence from alcohol, though acamprosate has stronger evidence for this indication 7, 6

Safety and Side Effects

• Common side effects include headache, agitation, anxiety, insomnia, dizziness, and drowsiness 6
• Aripiprazole has a lower propensity for weight gain, hyperprolactinaemia, and QT interval prolongation compared to some other antipsychotics 3
• Less likely to cause extrapyramidal symptoms than first-generation antipsychotics, though risk increases at higher doses 6
• Lower doses are recommended for elderly patients, those with hepatic impairment, or poor metabolizers of cytochrome P450 2D6 6

Special Considerations

• May be particularly useful when a less sedating antipsychotic is desired 6
• In combination therapy scenarios, lower doses of each medication may be used to maintain efficacy while reducing side effects 6
• For patients at risk for arrhythmias, aripiprazole is favored as it has not been associated with QTc prolongation or torsade de pointes 6

Clinical Management Strategies

• Two initiation/dosing strategies are commonly used based on patient symptom profile:
  • Rapid titration/high-dose strategy for acute symptoms
  • Slow titration/low-dose strategy for maintenance or less severe presentations 8
• Dosage adjustment is necessary when aripiprazole is coadministered with CYP3A4 and CYP2D6 inhibitors or inducers 3

Abilify represents a valuable therapeutic option with a unique mechanism of action that offers efficacy across multiple psychiatric conditions while maintaining a generally favorable side effect profile compared to many other antipsychotics.