Objective: To discuss the clinical effect of Xietu Huayu decoction on intractable insomnia (phlegm and blood stasis in the interior)

and its effect on monoamine neurotransmitter and inflammatory factor. Method: One hundred and seventy patients were randomly divided into control group (85 cases) and observation group (85 cases) by random number table. Both groups were given sleep hygiene guidance

cognitive-behavioral therapy and psychotherapy for non-pharmacological interventions. Patients in control group took Estazolam tablets at bed time

1-2 mg/day. Patients in observation group took Xietu Huayu decoction

1 dose/day. The courses of treatment were 4 weeks. Before and after the treatment

scores of pittsburgh sleep quality index (PSQI)

self-rating depression scale (SDS)

self-rating anxiety scale (SAS) and phlegm and blood stasis in the interior were scored. Total sleep time

sleep period time

sleep latency and awakening frequency were recorded by polysomnogram. Levels of interleukin-1β (IL-1β)

tumor necrosis factor-α (TNF-α)

interleukin-6 (IL-6)

5-hydroxytryptamine (5-HT) and 5-hydroxy indoleacetic acid (5-HIAA) were detected. Result: The total clinical effect rate in observation group was 93.9%which was higher than 80.25%in control group (P<0.01). Scores of sleep quality

sleep time

sleep efficiency

hypnotic

daytime function

the total scores and scores of SDS

SAS and phlegm and blood stasis in the interior were lower than those in control group (P<0.01). After the treatment

the total sleep time

sleep latency and awakening frequency were less than that in control group (P<0.01). Levels of IL-1β

TNF-α

5-HT and 5-HIAA were higher than control group (P<0.01)

whereas levels of IL-6 was lower than control group (P<0.01). Conclusion: Xietu Huayu decoction can ameliorate sleep quality

prolong sleep time of the patients' with intractable insomnia (phlegm and blood stasis in the interior)

with a superior clinical effect to Estazolam tablets

and its mechanism of action may be correlated to the regulation of levels of inflammatory mediator and monoamine neurotransmitter.