Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg

Expert Opin Drug Saf. 2009 Nov;8(6):615-26. doi: 10.1517/14740330903260790.


Objectives: To assess the cognitive effects of single doses of solifenacin 10 mg compared with placebo (primary objective) and oxybutynin immediate release (IR) 10 mg (secondary objective) in elderly subjects.

Methods: Single-centre, randomised, double-blind, placebo-controlled study in 12 healthy elderly volunteers, with three crossover periods separated by two 14-day washout periods. Each sequence consisted of a single dose of solifenacin 10 mg in one period, oxybutynin IR 10 mg in another and placebo in another. Aspects of attention, information processing, working memory, episodic memory and self-rated mood and alertness were tested using the validated Cognitive Drug Research computerised assessment system.

Results: There was no evidence from absolute mean values or changes from baseline to suggest that solifenacin 10 mg impaired cognition or self-ratings of mood and alertness versus placebo. Post-hoc ANCOVA showed no statistically significant cognitive deterioration with solifenacin versus placebo, when measured at a time point closest to the probable C(max) of solifenacin. Oxybutynin was associated with statistically significant impairments in several measures of cognitive function at a time point corresponding with its probable C(max).

Conclusion: In this pilot study, single 10 mg doses of solifenacin did not show any clear propensity to impair cognitive function in a healthy elderly population.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Attention / drug effects
  • Cognition / drug effects
  • Cognition Disorders / chemically induced*
  • Cognition Disorders / epidemiology
  • Cognition Disorders / psychology
  • Cross-Over Studies
  • Executive Function / drug effects
  • Female
  • Humans
  • Hypnotics and Sedatives*
  • Learning / drug effects
  • Male
  • Mandelic Acids / pharmacology
  • Memory / drug effects
  • Memory, Short-Term / drug effects
  • Muscarinic Antagonists / administration & dosage
  • Muscarinic Antagonists / adverse effects*
  • Neuropsychological Tests
  • Parasympatholytics / pharmacology
  • Pilot Projects
  • Quinuclidines / administration & dosage
  • Quinuclidines / adverse effects*
  • Reaction Time / drug effects
  • Risk
  • Sample Size
  • Solifenacin Succinate
  • Tetrahydroisoquinolines / administration & dosage
  • Tetrahydroisoquinolines / adverse effects*


  • Hypnotics and Sedatives
  • Mandelic Acids
  • Muscarinic Antagonists
  • Parasympatholytics
  • Quinuclidines
  • Tetrahydroisoquinolines
  • oxybutynin
  • Solifenacin Succinate