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

ObjectiveTo evaluate the effect of HuaDan Anshen Mistura (mistura) in clinical treatment of Chinese patients with insomnia.MethodsIn 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.ResultsTotal SDRS scores decreased in all three groups, and there were significant differences between the placebo group and the low- and high-dose mistura groups (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 HuaDan Anshen 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).ConclusionHuaDan Anshen Mistura is an effective and generally well-tolerated hypnotic medicine for the treatment of Chinese patients with insomnia.