Evaluation of antihistamine-related daytime sleepiness. A double-blind, placebo-controlled study with terfenadine

Allergy. 1992 Oct;47(5):532-4. doi: 10.1111/j.1398-9995.1992.tb00678.x.

Abstract

The daytime sleepiness potentially associated with antihistamines was evaluated by the multiple sleep latency test (MSLT) in a study comparing terfenadine with placebo. According to a double-blind, randomized, cross-over design, 12 healthy men were given either 120 mg terfenadine or placebo once daily in the morning, for 3 consecutive days with a 5-day interval. EEG-polygraphic recordings were made each study day at 9:30 and 11:30 a.m., and 1:30, 3:30, and 5:30 p.m., and the tendency to fall asleep was measured. All mean stage-1 sleep latencies throughout the study failed to show any significant difference between terfenadine and placebo. Accordingly, psychomotor performance assessed by visual and auditory reaction time did not change after treatment. The results of this study confirmed that terfenadine does not induce daytime sleepiness as objectively measured by MSLT.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Circadian Rhythm
  • Double-Blind Method
  • Electroencephalography
  • Evaluation Studies as Topic
  • Humans
  • Male
  • Psychomotor Performance / drug effects
  • Psychomotor Performance / physiology
  • Sleep Stages / drug effects*
  • Sleep Stages / physiology
  • Terfenadine / pharmacology*

Substances

  • Terfenadine