Risperidone is a medication that doctors sometimes prescribe to help manage severe agitation or aggression in people with Alzheimer’s disease and other forms of dementia, especially when non-drug approaches have not worked[1][2]. However, recent large-scale research has raised serious concerns about its safety, particularly regarding the risk of stroke, even in patients who do not have a history of heart disease or stroke[1][2][3].
## What Is Risperidone and Why Is It Used?
Risperidone belongs to a class of drugs called antipsychotics. In the United Kingdom, it is the only antipsychotic officially licensed for treating behavioral symptoms in dementia, such as severe agitation or aggression[1][2]. These symptoms can be very distressing for both the person with dementia and their caregivers, and sometimes medications are considered when other strategies fail[2]. About half of people with dementia experience agitation, which can make daily life extremely difficult[2].
## What Does the Latest Research Say About Safety?
A major study published in the British Journal of Psychiatry looked at over 165,000 people with dementia in the UK[1][2][3]. The researchers compared those who took risperidone to those who did not. They found that the risk of having a stroke was significantly higher in people taking risperidone, regardless of their previous health[1][2][3]. The risk was about 28% higher compared to those not taking the drug[3]. Importantly, this increased risk was seen even in people who had no history of heart disease or stroke, meaning there does not appear to be a “safe group” for using risperidone in dementia[1][2].
Dr. Byron Creese, one of the study authors, explained that while it was already known that risperidone could increase stroke risk, the new findings show that this risk is consistent across all types of patients, not just those with existing health problems[1][2]. This challenges previous assumptions that risperidone might be safer for certain groups.
## How Is Risperidone Prescribed in Practice?
Despite these risks, risperidone is still sometimes used because severe agitation can be very hard to manage without medication. However, guidelines from organizations like the UK’s National Institute for Health and Care Excellence (NICE) recommend that antipsychotics like risperidone should only be used for the shortest time possible, at the lowest effective dose, and only when symptoms are severe and could cause harm[5]. The recommended duration is usually just one to three months[5].
In reality, studies show that many people with dementia are prescribed antipsychotics for much longer than recommended, sometimes more than seven months, and at higher doses than advised[5]. This increases the potential for serious side effects, including not only stroke but also pneumonia, worsening memory, and even a higher risk of death[5].
## What Are the Alternatives?
Because of the risks associated with risperidone, doctors and families are encouraged to try non-drug approaches first. These might include changes to the person’s environment, routines, or care strategies to reduce agitation. When medications are necessary, it is important to use them at the lowest possible dose for the shortest possible time, and to monitor closely for side effects[5].
Recently, a new medication called brexpiprazole has been approved by the FDA specifically for agitation associated with Alzheimer’s disease[4]. Clinical trials have shown that brexpiprazole can reduce agitation with a different side effect profile than risperidone, though it can still cause issues like headache, dizziness, and urinary tract infections[4]. It is not yet clear if brexpiprazole carries the same stroke risk as risperidone, but it represents another option for doctors and families to consider[4].
## What Should Patients and Families Know?
If a loved one with Alzheimer’s disease is experiencing severe agitation or aggression, it is important to discuss all options with their doctor. Risperidone may help in some cases, but it is not without serious risks, especially the increased chance of stroke, which applies to all patients, not just those with previous health problems[1][2][3]. The decision to use risperidone should be made carefully, weighing the potential benefits against the risks, and only after other approaches have been tried[5].
Families should also be aware that antipsychotics like risperidone are not meant for long-term use in dementia. If the medication is prescribed, it should be at the lowest effective dose and for the shortest time possible, with regular reviews to see if it can be stopped[5]. Open communication with healthcare providers is key to ensuring the safest and most effective care.
## Final Thoughts
Risperidone can be effective for managing severe agitation in Alzheimer’s disease, but it is not a safe choice for everyone. The latest evidence shows that it increases the risk of stroke in all patients with dementia, regardless of their health history[1][2][3]. Because of this, it should only be used as a last resort, after other strategies have failed, and for the shortest time possible[5]. Families and caregivers should work closely with doctors to explore all options and make informed decisions about treatment.
[1] [2] [3] [4] [5]
