title: Comparative studies on the effects of the combination drug lorazepam plus diphenhydramine (Somnium) versus lorazepam on the noopsyche, thymopsyche and psychophysiology in nonorganic insomnia related to generalized anxiety disorder.
abstract: 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.
authors.affiliation: Department of Psychiatry, University of Vienna, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Grünberger
authors.forename: B
authors.initials: B
authors.lastname: Saletu
authors.forename: L
authors.initials: L
authors.lastname: Linzmayer
authors.forename: G
authors.initials: G
authors.lastname: Böck
authors.forename: S
authors.initials: S
authors.lastname: Weissgram
authors.forename: N
authors.initials: N
authors.lastname: Brandstaätter
authors.forename: R
authors.initials: R
authors.lastname: Frey
authors.forename: G
authors.initials: G
authors.lastname: Saletu-Zyhlarz
mesh_terms: D000328:Adult; D000368:Aged; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000503:physiopathology; D004155:Diphenhydramine / Q000008:administration & dosage / Q000627:therapeutic use*; D016002:Discriminant Analysis; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D008140:Lorazepam / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008347:Manifest Anxiety Scale; D008568:Memory / Q000187:drug effects; D008875:Middle Aged; D015999:Multivariate Analysis; D011603:Psychophysiology; D012025:Reflex, Pupillary / Q000187:drug effects; D016037:Single-Blind Method; D012879:Skin Physiological Phenomena / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology; D013732:Test Anxiety Scale
chemical_list: D004338:Drug Combinations; D006993:Hypnotics and Sedatives; C077724:Somnium; D004155:Diphenhydramine; D008140:Lorazepam