Aripiprazole Indications: FDA-Approved and Off-Label Uses
Aripiprazole is a second-generation (atypical) antipsychotic approved for the treatment of schizophrenia, bipolar disorder, depression and autism spectrum disorders.
This article explores FDA-approved indications, dosing and evidence base for common off-label uses.
Aripiprazole was originally approved in 2002 for the treatment of schizophrenia. Currently, the FDA has approved aripiprazole for the treatment of bipolar disorder (mania and mixed episodes and as maintenance treatment), as adjunctive treatment for major depressive disorder (2006) and for autism spectrum disorders (2007).
Below is a list of approved indications and dosing, this information has been extracted from the product prescribing information .
For oral formulations (tablet, orally disintegrating tablet and oral solution):
|Indication||Initial Dose||Recommended Dose||Maximum Dose|
|Adults||10-15 mg/day||10-15 mg/day||30 mg/day|
|Adolescents||2 mg/day||10 mg/day||30 mg/day|
|Treatment of manic or mixed episodes|
|15 mg/day||15 mg/day||30 mg/day|
Adjunt to lithium or valproate
|10-15 mg/day||15 mg/day||30 mg/day|
Monotherapy or adjunct to lithium or valproate
|2 mg/day||10 mg/day||30 mg/day|
|Maintenance treatment of bipolar I disorder||Doses not available in product monograph.|
|Major Depressive Disorder|
|Adjunct to antidepressants for the treatment of MDD||2-5 mg/day||5-10 mg/day||15 mg/day|
|Autism Spectrum Disorders|
|Irritability associated with autistic disorder.|
|2 mg/day||5-10 mg/day||15 mg/day|
For the IM injection:
|Indication||Initial Dose||Maximum dose|
|Agitation associated with schizophrenia or bipolar mania.|
|9.75 mg/1.3 mL injected IM||30 mg/day injected IM|
List of selected off-label uses
The table below summarizes the findings of a comparative effectiveness review by the Agency for Healthcare Research and Quality .
Most of the uses listed in the table lack of controlled trials, which highlights the need for new studies assessing the evidence for the use of aripiprazole in different clinical conditions.
|Generalized anxiety disorder||No trials|
|Social Phobia||No trials|
|Attention-deficit hyperactivity disorder|
|No co-occuring disorders||No trials|
|Bipolar Children||Low or very low evidence of efficacy|
|Mentally retarded children||No trials|
|Overall||Moderate or high evidence of efficacy|
|Psychosis||Low or very low evidence of efficacy|
|Agitation||Low or very low evidence of efficacy|
|MDD monotherapy||No trials|
|Eating disorders||No trials|
|Augmentation with SSRI||No trials|
|Augmentation of citalopram||No trials|
|Borderline personality disorder||Low or very low evidence of efficacy|
|Schizotypal personality disorder||No trials|
|Post-traumatic stress disorder||No trials|
|Alcohol||Moderate or high evidence of inefficacy|
|Methamphetamine||Low or very low evidence of inefficacy|
|Methadone users||No trials|
|Tourette's syndrome||No trials|
More Information on Off-Label Use
Katzman MA. Aripiprazole: a clinical review of its use for the treatment of anxiety disorders and anxiety as a comorbidity in mental illness. Journal of affective disorders. 2011;128:S11-S20.
” A number of studies have shown atypical antipsychotics to be effective in anxiety, and currently available data suggest that aripiprazole augmentation in patients with anxiety disorders is likely as effective as other atypical antipsychotic drugs.
Although there have been no randomized, controlled trials, aripiprazole has been found to be effective in treating anxiety disorders in two open-label trials.
This combined with the larger data base demonstrating its utility in bipolar disorder and depression, its safety profile and its unique mechanism of action, make aripiprazole for anxiety an intriguing avenue of exploration.”
De Deyn PP, Drenth AF, Kremer BP, Oude Voshaar RC, Van Dam D. Aripiprazole in the treatment of Alzheimer’s disease. Expert opinion on pharmacotherapy. 2013(0):1-16
In randomized placebo-controlled clinical trials, aripiprazole shows modest efficacy in the treatment of AD-related psychosis. Neuropsychiatric symptoms alleviated were predominantly psychotic features and agitation. In individual trials, aripiprazole was generally well tolerated, serious side effects were seldom reported and included accidental injury and somnolence. Meta-analyses however demonstrated increased mortality as a class effect for atypical, but also for typical antipsychotics.
No increased cardiovascular outcomes, cerebrovascular accidents, increased appetite or weight gain were demonstrated in meta-analyses for aripiprazole-treated patients with psychosis of dementia. Aripiprazole was found to induce sedation.
Aripiprazole should only be used in selected patient populations resistant to non-pharmacological treatment with persisting or severe psychotic symptoms and/or agitation, and in which symptoms lead to significant morbidity, patient suffering and potential self-harm. The indication for continuing treatment should be revised regularly.
Trunko ME, Schwartz TA, Duvvuri V, Kaye WH. Aripiprazole in anorexia nervosa and low‐weight bulimia nervosa: Case reports. International Journal of Eating Disorders. 2011;44(3):269-75
There has been much interest in the use of atypical antipsychotics in anorexia nervosa (AN). However, newer, more weight-neutral medications have not been studied in AN, and there are no reports of the use of antipsychotics in bulimia nervosa (BN).
We report on the treatment of eight patients (five with AN and three with BN) with aripiprazole for time periods of four months to more than three years.
All individuals had reduced distress around eating, fewer obsessional thoughts about food, weight and body image, significant lessening of eating-disordered behaviors, and gradual weight restoration where appropriate. Depression, generalized anxiety, and cognitive flexibility improved as well.
In summary, these findings support the need to perform controlled trials of aripiprazole in AN and BN.
- Aripiprazole Lauroxil Extended-Release Injectable (ARISTADA)
- Mechanism of Action of Aripiprazole
- Pharmacokinetics of Aripiprazole: Clinical Summary
- Aripiprazole for Schizophrenia
- Aripiprazole for Mania
- Aripiprazole for Depression
- Otsuka America Pharmaceutical, Inc. Abilify (aripiprazole) prescribing information. Retrieved from http://www.abilify.com [retrieval date: February 29, 2013]
- Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T. Off-Label Use of Atypical Antipsychotics: An Update. Comparative Effectiveness Review No. 43. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm
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