Aripiprazole (Abilify) in Elderly Patients: Safety Concerns and Recommendations
Aripiprazole should be avoided in elderly patients due to increased mortality risk in those with dementia-related psychosis and significant adverse effects including somnolence, incontinence, and cerebrovascular events. 1
Safety Concerns in Elderly Patients
Black Box Warning
- Elderly patients with dementia-related psychosis treated with antipsychotics, including aripiprazole, have an increased risk of death 1
- Aripiprazole is NOT FDA-approved for treatment of dementia-related psychosis 1
Adverse Effects in Elderly
In placebo-controlled studies of aripiprazole in elderly patients with Alzheimer's disease, the following adverse effects occurred at ≥3% and at least twice the placebo rate 1:
- Lethargy (5% vs 2% placebo)
- Somnolence/sedation (8% vs 3% placebo)
- Urinary incontinence (5% vs 1% placebo)
- Excessive salivation (4% vs 0% placebo)
- Lightheadedness (4% vs 1% placebo)
Cerebrovascular Events
- Increased incidence of cerebrovascular adverse events (stroke, TIA) including fatalities in aripiprazole-treated elderly patients 1
- Dose-dependent relationship for cerebrovascular events was observed 1
Beers Criteria Recommendations
The American Geriatrics Society 2019 Beers Criteria® identifies antipsychotics as potentially inappropriate medications in older adults 2. The criteria specifically recommend:
- Avoiding antipsychotics in elderly patients due to the risk of increased mortality
- Strong recommendation with high quality of evidence for avoiding these medications in elderly patients with dementia
Alternative Approaches for Elderly Patients with Psychosis
If treatment for psychosis is necessary in elderly patients, consider:
Quetiapine as a preferred option for psychosis in elderly patients, particularly those with Parkinson's disease 3:
- Start with very low doses (12.5-25 mg/day)
- Gradually titrate according to response and tolerance
- Maximum habitual dose rarely exceeds 150 mg/day
- Lower risk of extrapyramidal symptoms compared to other antipsychotics
Clozapine as a second-line option if quetiapine is ineffective:
- More effective but requires hematologic monitoring due to risk of agranulocytosis 3
- Reserved for cases where benefits clearly outweigh risks
Dosing Considerations if Aripiprazole Must Be Used
If aripiprazole must be used in an elderly patient (for non-dementia indications where benefits clearly outweigh risks):
- Start with much lower doses than used in younger adults
- In studies of elderly psychiatric inpatients, median starting dose was 5 mg daily 4
- Median maximum dose was 10 mg daily 4
- Monitor closely for adverse effects, particularly agitation/activation (most common side effect in elderly, 8%) 4
Monitoring Requirements
If an antipsychotic must be used in an elderly patient, careful monitoring is essential:
- Baseline and regular assessment of cardiovascular status
- Monitor for orthostatic hypotension
- Watch for excessive sedation which may increase fall risk
- Assess for extrapyramidal symptoms
- Regular evaluation of cognitive function
- Monitor for difficulty swallowing or excessive somnolence that could lead to aspiration 1
Conclusion
Given the significant safety concerns and FDA warnings, aripiprazole should generally be avoided in elderly patients, particularly those with dementia-related psychosis. When antipsychotic treatment is absolutely necessary, quetiapine at low doses is typically a safer alternative for elderly patients. Any use of antipsychotics in the elderly should be limited to the lowest effective dose for the shortest possible duration with regular reassessment of risks versus benefits.