BACKGROUND: @entity1245 cause a high proportion of adverse effects while non- @entity1245 compounds have demonstrated high efficacy and less adverse effects in @entity1 with @entity22 . The objective of this study was to compare the effectiveness and safety of non-BZ @entity12124 and @entity2492 in @entity22 . METHODS: This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 @entity1 were enrolled, of which 45 @entity1 completed the study. @entity1 who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each @entity1 kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and @entity25 , the number of awakenings and incidence of rebound @entity22 . RESULTS: The data revealed a significant decrease in sleep latency from baseline to Week 2 for @entity1 receiving @entity12124 10 mg and @entity2492 10 mg. @entity1 receiving @entity12124 exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received @entity2492 . There was no significant difference in the frequency of adverse effects between the @entity12124 and @entity2492 groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the @entity12124 group. CONCLUSION: There was no significant difference between @entity12124 and @entity2492 in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either @entity2492 or @entity12124 is free from next-day residual effects.

A double-blind, randomized, comparative study to evaluate the efficacy and safety of XXXX versus @entity2492 in shortening sleep latency in @entity22 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity1245 :: ('MESH:D001569', 'Chemical') :: ['Benzodiazepines', 'benzodiazepine'] @entity12124 :: ('MESH:C085665', 'Chemical') :: ['zaleplon'] @entity25 :: ('MESH:D012893', 'Disease') :: ['quality of sleep'] @entity2492 :: ('MESH:C049109', 'Chemical') :: ['zolpidem'] @entity22 :: ('MESH:D007319', 'Disease') :: ['primary insomnia', 'insomnia']
@entity12124 :: (MESH:C085665,Chemical) :: ['zaleplon']
