Random Double-Blind Research Of Zaleplon In Clinical Treatment Of Long-term Insomnia

Objective: To evaluate the clinical efficacy and safety of zaleplon compared with zopiclon with random double blind research method .Method : Randomly divide 80 patients with insomnia coincident with CCMD-III diagnose criteria into two groups (the zaleplon group and the zopiclon group), 40 patients each group. Use random double blind research method, inform the patient take the zaleplon or zopiclon before sleeping. Evaluate the clinical efficacy with sleep dysfunction rate scales and clinical general impassion scale before therapy and at the 4th day, the 8th day, the 15th day taking the medicine and the 6th day after therapy. Evaluate the side effect with TESS and the security with the medical check of blood routine, urine routine, blood biochemistry and EEG. After collecting the data, discover the blind, and differentiate A and B group, record the data, analyze with SAS statistic softy-ware. Then discover the true drug group of A and B after data analysis.Results: there is comparability of two group of the demography characteristics, duration, history, and cause of illness according to statistic analysis. Before treatment, the total value of SDKS is 1616?.88 (Zaleplon) and 16.5 + 5.12 (zopiclon) respectively, all the value of follow-up decreases after treatment, and there is statistical significance comparing with the value of SDRS before the treatment. There is no statistical significance between the total value of SDRS at the last follow-up of treatment and the one of the 6th day after stopping the drug. Comparing the value reduction of single marker of SDRS between'two groups, no statistical significance, excluding the quality of sleep at the 4th day of treatment.the value reduction of the frequency and the degree of the insomnia in early phase is larger than the one of the insomnia in final phase. The severe degree and the progress of CGI of the two groups is identical in every follow-up. The rate of side effect of the zaleplon is lower than the one of the zopiclon, 22.5% and 57.5% (P<0.001 ) respectively according to the statistical analysis. The systolic pressure of the pre-treatment with zaleplon is higher than the one of the post-treatment.Conclusion: the effect of the zaleplon on long-term insomnia is same as the one of the zopiclon. The side effect of the zaleplon is less than the one of the zopiclon.