Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Previous human pharmacological and toxicological studies demonstrated advantages of the combination drug Somnium [SOM, lorazepam (LOR) 1 mg plus diphenhydramine 25 mg] over 1 mg LOR alone, as it showed synergistic effects in hypnotic properties and antagonistic effects in regard to toxicity. In the present double-blind, parallel-group study, hypnotic and anxiolytic effects of SOM were studied in 44 patients with non-organic insomnia related to mild generalized anxiety disorder (GAD), as compared with LOR alone. After a placebo run-in phase of 1 week, they received active treatment (1 tablet SOM or LOR 1 mg) for 4 weeks and thereafter placebo again for 1 week. Clinical evaluations included the physician's general assessment of efficacy, tolerance and adverse effects, the Hamilton anxiety rating scale (HAMA), the Zung self-rating anxiety scale (SAS) and depression scale, the withdrawal symptom scale (WSS), hematology and blood chemistry. Sleep laboratory evaluations included objective and subjective sleep and awakening quality, measured by polysomnography, self-rating of sleep and awakening quality (SSA) and a psychometric test battery in the morning, as well as measurement of daytime brain function, objectivated by EEG mapping. Physicians' global evaluation of insomnia demonstrated no changes in the pre-drug placebo period, moderate improvement under both drugs, with a marginal advantage of SOM over LOR in the first 2 weeks, and a return to pre-drug values in the post-drug placebo period. Anxiety improved in observer ratings (HAMA) under both drugs, in self-rating (SAS) under the combination drug only, with the scores returning to pre-drug placebo values after post-drug placebo substitution. There were no significant findings in the self-rating depression scale and the WSS, with the exception of an improvement in the WSS score 4 weeks after SOM, as compared with pre-drug placebo. There were no rebound phenomena. Both drugs were well tolerated-in regard to both adverse effects and laboratory findings. Confirmatory statistics on the polysomnographically recorded target variable latency to sleep onset stage 2 demonstrated a significant shortening of sleep latency after SOM and a significant superiority of the combination drug SOM over LOR after acute dosing, as compared with pre-drug placebo. Descriptive statistics demonstrated further a significant improvement of sleep efficiency and total sleep time after SOM and of wakefulness time and number of awakenings during the total sleep period after both drugs, but no interdrug differences. Sleep architecture remained unchanged. Subjective sleep quality improved with both drugs, morning drowsiness and the total SSA score only with SOM, while LOR was superior to SOM regarding morning somatic complaints. There were neither changes nor interdrug differences in the morning noopsyche. In psychophysiology, critical flicker frequency decreased more under SOM than LOR. After 4 weeks therapy, no significant findings in polysomnography and subjective sleep and awakening were seen, except for an increase in movement time under LOR (tolerance development). In objective awakening quality, psychometry revealed an improvement of reaction time under SOM and a decrease of attention variability and an increase in fine-motor activity under LOR, with an interdrug comparison showing a significant superiority of SOM over LOR in regard to reaction time, reaction time variability and reaction time performance. After placebo substitution, rebound phenomena were seen in polysomnography and subjective sleep and awakening in the 1st night of the SOM group only, which were gone in the 7th placebo night, however. Noopsychic performance remained improved in both groups, with a superiority of SOM to LOR in regard to reaction time and reaction time variability. (ABSTRACT TRUNCATED)
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PMID:Nonorganic insomnia in generalized anxiety disorder. 2. Comparative studies on sleep, awakening, daytime vigilance and anxiety under lorazepam plus diphenhydramine (Somnium) versus lorazepam alone, utilizing clinical, polysomnographic and EEG mapping methods. 931 45

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.
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PMID: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. 950 Jan 29