Comparative study of midazolam and vesparax in moderate or severe insomnia in female surgical patients.

A double-blind study was conducted in 60 female patients with moderate or severe insomnia, hospitalized for gynaecological surgery. After an initial 2-day placebo selection phase, 30 subjects received 15 mg midazolam and the remaining 30 received 1 tablet Vesparax (= 50 mg hydroxyzine, 150 mg secobarbital, 50 mg brallobarbital) for 5 nights. This verum phase was immediately followed by a 2-day placebo withdrawal phase in order to study the occurrence of rebound phenomena. Both verum compounds were effective in hastening sleep onset, increasing sleep duration, and improving sleep quality, without causing residual effects on the following day. There was no difference in effect between the two agents. Neither active drug caused rebound effects on withdrawal.

RCT Entities:   Population Interventions Outcomes