Behavioral disturbance in dementia
Psychotic and behavioral symptoms (aggression, agitation, delusions, sleep disturbance) in patients with dementia. Non-pharmacological strategies are first-line; antipsychotics are restricted to severe cases.
ICD-10 F02.84 drugs
Also known as: BPSD
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- DHaloperidolNot recommended · First-generation antipsychotics. Butyrophenone derivativesIn elderly patients with dementia, antipsychotics are used only for severe aggression or psychotic features with risk of harm. The FDA boxed warning (2008) and EMA notice (2011) cite a 1.6–1.7-fold increased mortality risk with antipsychotics in elderly dementia. NICE and Beers Criteria 2023 recommend avoiding routine use, employing minimal doses and short courses (no more than 6–12 weeks) with regular discontinuation attempts.
- FDiazepamNot recommended · Anxiolytics. Benzodiazepine derivativesIn elderly patients with dementia, benzodiazepines are not used for behavioral disturbance. Beers Criteria 2023 lists benzodiazepines as potentially inappropriate in older adults: increased risk of falls, hip fractures, delirium, and paradoxical aggression. Preferred options are non-pharmacological strategies and, if necessary, low-dose atypical antipsychotics.
- FLithiumNot recommended · Psycholeptics. LithiumLithium use without therapeutic drug monitoring is unacceptable. Narrow therapeutic range (0.6–1.2 mmol/L) and toxicity at levels above 1.5 mmol/L require regular monitoring every 3–6 months and with any change in dose, diet, or comedications. Without TDM the drug is not prescribed.
- FPhenazepamNot recommended · Anxiolytics. Benzodiazepine derivativesPhenazepam is not used in elderly patients with dementia. Long half-life and active metabolites lead to accumulation, with risks of falls, fractures, paradoxical aggression, and delirium. Evidence base for use in this population is absent.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit