Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer’s Disease: Timing and Duration of Adverse Events - Takeaways - MDSpire

Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer’s Disease: Timing and Duration of Adverse Events

  • By

  • Anton P. Porsteinsson

  • Sanjeda R. Chumki

  • David Wang

  • Pedro Such

  • Anton M. Palma

  • Zhen Zhang

  • Alpesh Shah

  • Uwa Kalu

  • C. Brendan Montano

  • April 10, 2026

  • 0 min

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  • 1

    Brexpiprazole 2 or 3 mg/day was well tolerated in 12-week trials for agitation in Alzheimer’s disease, with similar adverse event timing and duration as placebo.

  • 2

    Participants who discontinued treatment due to adverse events did so earlier with placebo compared to brexpiprazole, indicating better tolerability.

  • 3

    In an extension trial, brexpiprazole remained well tolerated for up to 24 weeks, showing no worsening of cognitive function.

  • 4

    Common adverse events with brexpiprazole included insomnia, somnolence, nasopharyngitis, and urinary tract infections, with low incidence of serious events.

  • 5

    The 2023 amendment to brexpiprazole's boxed warning clarified its indication for agitation in Alzheimer’s disease, excluding dementia-related psychosis without agitation.

Original Source(s)

Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer’s Disease: Timing and Duration of Adverse Events

  • by Anton P. Porsteinsson, Sanjeda R. Chumki, David Wang, Pedro Such, Anton M. Palma, Zhen Zhang, Alpesh Shah, Uwa Kalu, C. Brendan Montano

  • April 10, 2026

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