Abstract:Objective To investigate the efficacy and adverse effects of Qiye Shen'an Tablet versus estazolam tablets in the treatment of primary insomnia. Methods A total of 200 patients with primary insomnia were enrolled and randomly divided into Qiye Shen'an group and estazolam tablet group, with 100 patients in each group. The patients in the Qiye Shen'an Tablet group were treated with Qiye Shen'an Tablet, and those in the estazolam group were treated with estazolam tablets. The course of treatment was 4 weeks for both groups. The Pittsburgh sleep quality index (PSQI) was observed and compared between the two groups, and the reduction rate of total PSQI score was used to evaluate the therapeutic effect. Adverse drug reactions were recorded at any time during treatment, and the incidence rate of adverse events was compared between the two groups after the treatment ended. Results The estazolam group had a better clinical outcome than the Qiye Shen'an Tablet group (P<0.05). Both groups had a significant reduction in PSQI score after treatment (P<0.05), while the estazolam group had a significantly greater reduction in PSQI score compared with the Qiye Shen'an Tablet group (P<0.05). The Qiye Shen'an Tablet group had a significantly lower incidence rate of adverse events than the estazolam group (P<0.05). Conclusion Both Qiye Shen'an Tablet and estazolam are effective in the treatment of insomnia; estazolam have a better clinical effect than Qiye Shen'an Tablet, while Qiye Shen'an Tablet has fewer and milder adverse effects and higher safety than estazolam.