ASTEMIZOLE-D CAUSES LESS SLEEP IMPAIRMENT THAN LORATADINE-D

This randomized, double-blind, double-dummy, parallelgroup trial was i nitiated to evaluate and compare the tolerability of once-daily astemi zole-D capsules (10 mg astemizole/240 mg pseudoephedrine) and twice-da ily loratadine-D tablets (5 mg loratadine/120 mg pseudoephedrine), wit h particular reference to the impact of treatment on quality of sleep. A total of 240 healthy volunteers participated in this study with a t reatment duration of 3 days. Astemizole-D consistently produced less s leep impairment than loratadine-D with statistically significant diffe rences in favour of astemizole-D reported for night-time waking on day s 4 and 5 (P = 0.004 and P = 0.006, respectively), as well as for nigh t-time restlessness on day 4 and the total score for all sleep paramet ers on day 4 (P < 0.05). Global evaluations of overall sleep quality a t the end of the trial also revealed some statistically significant di fferences in favour of astemizole-D. Both drugs were well tolerated an d there were no differences in the incidence and type of adverse event s reported in the two treatment groups. Slight changes in heart rate a nd blood-pressure were observed in both treatment groups, but these we re small and were not considered to be of clinical significance. In co nclusion, once-daily astemizole-D is well tolerated and appears to cau se less sleep impairment than twice-daily loratadine-D.