In a double-blind, parallel-group design study on
hypnotic and
anxiolytic effects of the
combination drug Somnium (
lorazepam 1 mg +
diphenhydramine 25 mg) (SOM) as compared with 1 mg
lorazepam (LOR) alone, daytime behavioral effects were studied in 44 patients with
nonorganic insomnia related to a mild generalized
anxiety disorder. After a placebo run-in phase of 1 week, they received active treatment for 4 weeks. Psychometric evaluations included 6 thymopsychic variables (somatic complaints, state anxiety, trait anxiety, self-rating anxiety and depression scale and adjective mood scale), 6 noopsychic variables (general, associative, numerical and total verbal memory; correct reproductions and errors-Benton visual memory test), 4 pupillary measures (pupillary diameter, latency, relative change in % and half recovery time in pupillary response) and 6 skin conductance measures (baseline, latency, ascending time, time to peak, skin conductance response and skin conductance response maximum). Multivariate statistical analysis of the thymopsyche demonstrated significant improvement after both compounds, with the
combination drug significantly superior to its single component
lorazepam. Also regarding noopsychic measures,
Somnium was significantly superior to the single component
lorazepam, as specifically verbal memory was improved after
Somnium, while opposite changes occurred after
lorazepam alone. Pupillary measures revealed no significant overall inter-
drug differences, whereas skin conductance findings demonstrated that the
combination drug Somnium was superior to the single component
lorazepam also in regard to the
anxiolytic effect at the autonomic nervous system level.