Adverse reactions to triazolam, flurazepam, and placebo in controlled clinical trials.

Adverse reactions were evaluated from 45 double-blind controlled clinical trials involving triazolam 0.25 mg (N = 731), triazolam 0.5 mg (N = 2004), flurazepam 30 mg (N = 899), and placebo (N = 1771). Excessive CNS depression was the most frequent adverse effect, reported in 14.2% of trials with triazolam 0.25 mg, 19.5% with triazolam 0.5 mg, 23.9% with flurazepam 30 mg, and 6.4% with placebo. With the exception of orolingual complaints associated with flurazepam, all other categories of adverse reactions were equally or more frequent with placebo than with active medications. Unusual or excessive adverse reactions were not reported.