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Updated: Aug 18, 2026

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
Central nervous system side-effects of antihistamines in schoolchildren
Insights
Classical antihistamines may cause somnolence in children. However, newer antihistamines like astemizole and terfenadine do not show increased sedation compared to placebo in children. Performance was not negatively impacted by astemizole or chlorpheniramine in a study.
Area of Science:
- Pediatric Pharmacology
- Central Nervous System (CNS) Effects
- Antihistamine Research
Background:
- Limited research exists on the central nervous system (CNS) effects of classical antihistamines in pediatric populations.
- Clinical data suggest classical antihistamines are associated with increased somnolence compared to placebo.
- Newer antihistamines, astemizole and terfenadine, demonstrate no greater sedative effect than placebo in adults.
Purpose of the Study:
- To investigate the central nervous system (CNS) effects of astemizole and chlorpheniramine in schoolchildren.
- To compare the sedative potential of classical antihistamines versus newer agents in pediatric populations.
- To assess the impact of antihistamines on cognitive performance in children.
Main Methods:
- A double-blind, cross-over trial was conducted.
- The study involved schoolchildren as participants.
- Central nervous system (CNS) effects and performance were evaluated.
Main Results:
- No significant difference in inducing somnolence was observed between placebo and astemizole or terfenadine in children.
- The double-blind, cross-over trial found no negative impact on performance with either astemizole or chlorpheniramine.
- Classical antihistamines show a higher incidence of somnolence than placebo.
Conclusions:
- Newer antihistamines (astemizole, terfenadine) do not appear to cause greater somnolence than placebo in children.
- Astemizole and chlorpheniramine did not negatively affect cognitive performance in schoolchildren during the trial.
- Further research may be needed to fully elucidate the CNS effects of various antihistamines in pediatric populations.
Abstract:
There are no studies available in the literature on the effects of classical antihistamines on the central nervous system (CNS) in children. Clinical studies indicate that somnolence occurs more often with classical antihistamines than with placebo. There is no difference in inducing somnolence in children between placebo and astemizole or terfenadine, two new antihistamines that have thoroughly been shown to have no sedative effect greater than placebo in adults. A double-blind, cross-over trial investigating the CNS-effects of astemizole and chlorpheniramine in schoolchildren failed to show a negative effect of either of these drugs on performance.
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