Commonly Prescribed Antipsychotics for Dementia

Black Box Warning for Elderly Patients

Doctor discussing prescription with senior patient

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If someone you know has Alzheimer’s disease or vascular dementia, they may be experiencing a variety of non-memory-related symptoms, including aggressiveness, agitation, delusions, and hallucinations. To address these challenging symptoms, doctors often prescribe antipsychotic medications.

But the adverse events associated with antipsychotic use can be dangerous, especially in older adults. To warn people of these risks, the Food and Drug Administration (FDA) issued a black box warning for all antipsychotic medications.

Black Box Warning

Black box warnings are the most serious warnings the FDA issues. They warn doctors and patients about serious or life-threatening adverse drug reactions. Antipsychotics earned a black box warning because they are associated with increased rates of stroke and death in older adults with dementia.

Antipsychotic Black Box Warning (full text)


WARNING: Increased Mortality in Elderly Patients With Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration* of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

[DRUG BRAND NAME (drug generic name)] is not approved for the treatment of patients with dementia-related psychosis.


*Modal duration means that the most common length of the trials used was 10 weeks.

Antipsychotics With Black Box Warnings

Both typical and atypical antipsychotic medications come with a black box warning. Below are just a few antipsychotic medications commonly prescribed for use in older adults with dementia.

Keep in mind that all antipsychotics come with a black box warning, not just those listed below.

Atypical Antipsychotics

Atypical antipsychotics are frequently used off-label to treat the mood and behavioral symptoms associated with dementia. Commonly prescribed atypical antipsychotics include:

Typical Antipsychotics

Typical antipsychotics may also be prescribed for off-label use. Common typical antipsychotics for dementia include:

Typical antipsychotics tend to cause extrapyramidal symptoms—such as stiffness and immobility—and metabolic syndrome. Therefore, these drugs are rarely, if ever, prescribed for use in adults with dementia.

Why Antipsychotics Are Still Used

Psychosis and agitation in dementia can cause considerable distress to an older person or to their caregivers. Because there are a limited number of medications that can treat this condition, your loved one's doctor may still use one or more antipsychotic medications that carry this black box warning. In a situation like this, the doctor will consider whether the potential benefits of using these medications are greater than the risks.

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4 Sources
Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. Maust DT, Kim HM, Seyfried LS, et al. Antipsychotics, other psychotropics, and the risk of death in patients with dementia: number needed to harm. JAMA Psychiatry. 2015;72(5):438-445. doi:10.1001/jamapsychiatry.2014.3018

  3. Reese TR, Thiel DJ, Cocker KE. Behavioral disorders in dementia: Appropriate nondrug interventions and antipsychotic use. Am Fam Physician. 2016;94(4):276-282.

  4. Steinberg M, Lyketsos CG. Atypical antipsychotic use in patients with dementia: managing safety concerns. Am J Psychiatry. 2012;169(9):900-906. doi:10.1176/appi.ajp.2012.12030342

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