Efficacy of HuaDan Anshen Mistura for treating insomnia: a randomized, double-blind, placebo-controlled, multi-center clinical trial

To evaluate the effect of Huadananshen mistura in clinical treatment of Chinese patients with insomnia.In this randomized, double-blind, placebo-controlled, multi-center study, 244 patients with insomnia were randomly assigned to a placebo group, a low-dose (10 mL/day), or a high-dose (20 mL/day) mistura group. Efficacy was assessed by using the sleep dysfunction rating scale (SDRS) and Clinical Global Impression-Improvement (CGI-I) scores. Safety and tolerability assessments included emergent adverse events, laboratory tests, and electrocardiograms.Total SDRS scores decreased in all three groups, and there were significant differences between the placebo group and the low- and high-dose mistura (P = 0.000). CGI-I ratings in the low- and high-dose mistura groups were significantly better than that of the placebo group (P = 0.000). Incidences of rebound insomnia were similar in all three groups (placebo group: 6.94%, low-dose mistura group: 12.99%, and high-dose mistura group: 10.96%; P = 0.475). The efficacy of Huadananshen mistura in the low- or high-dose group was significantly better than that of the placebo group (P = 0.000), but with no significant difference found between the low- and high-dose mistura groups (P = 0.887). The rates of adverse events were similar in the three groups (placebo 2.44%, low-dose mistura 0%, and high-dose mistura 5%; P = 0.088).Huadananshen mistura is an effective and generally well-tolerated hypnotic medicine for the treatment of Chinese patients with insomnia.