Psychotropic Medications & The Black Box Warning
I always try to be as conservative as possible with all psychotropic meds in my patients with dementia. I first look at the complete medication list and see if there are any meds which we can remove rather than add (in case they are contributing to current symptoms). The only medications FDA approved for dementia are cholinesterase inhibitors (e.g. donepezil, rivastigmine & galantamine) & memantine. They typically help primary & cognitive symptoms of dementia. They can sometimes (not necessarily typically) help the neuropsychiatric manifestations of dementia (e.g. insomnia, anxiety, agitation or hallucinations).
All antipsychotics carry a FDA warning to use with extreme caution in patients with dementia. Some studies have found a 2% risk of dying sooner in patients with dementia who take these meds (usually through cardiovascular illness like heart attack, stroke, or sudden death). There was at least one study refuting this finding. Psychiatry & use of psychotropic medications are not exact sciences (i.e. a lot of gray area). We should certainly heed the warning, but also look at the big picture. Because treatment options can be limited in those with dementia, sometimes these meds are the best choice (i.e. "lesser of all evils") to treat symptoms like hallucinations or paranoia.
I want to point out that the black boxwarning is partially a sociopolitical construct. In other words, these warnings appear when something gets a lot of negative press. For example, opiates got a black box warning because of severe addiction & deaths related to overdose). There is another group of medications called benzodiazepines. This includes lorazepam (aka Ativan) & other meds you may have heard of like diazepam (aka Valium), alprazolam (aka Xanax) & clonazepam (aka Klonopin). This group of medicines is the #1 medication cause of falls in the elderly. All it takes is one bad fall, and somebody dies or has a severe injury. There is no black box warning on these meds, but I view them as just as dangerous as antipsychotics (but in a slightly different way). They can receive anxiety quickly, but besides falls can also lead to confusion & sedation. Nine times out of ten, if I had to pick a benzo or an antipsychotic, I would usually pick seroquel first despite the black warning. 2 large studies showed seroquel to be the least risky of this group of medications. At least one other study has noted risperdal may be the least risk and highest efficacy in the elderly with dementia. However, other studies have not confirmed the latter statement. While we have made great strides in our field, we don't have all the answers. We need more research & have a lot left to learn.