To observe the clinical efficacy and safety of the treatment of insomnia of heart-kidney Yang deficiency type with Fuzi Decoction（附子汤）combined with Guizhi Gancao Longgu Muli Decoction（桂枝甘草龙骨牡蛎汤）.

A total of 114 patients with insomnia due to deficiency of heart and kidney yang were enrolled from January 2022 to December 2023. Simple randomization was performed using a random number table. The Western medicine group（n＝57）received zopiclone treatment，while the pattern differentiation group（n＝57）received Fuzi Tang combined with Guizhi Gancao Longgu Muli Tang. Both groups underwent continuous treatment for 4 weeks. The following parameters were assessed：Hamilton Anxiety Scale（HAMA）scores，5-hydroxytryptamine（5-HT），glutamate，gamma-aminobutyric acid（GABA），melatonin，Pittsburgh Sleep Quality Index（PSQI）scores，sleep architecture，TCM syndrome scores，and Hamilton Depression Scale（HAMD）scores. Efficacy and safety were statistically analyzed between groups.

Following treatment，both groups exhibited reduced HAMD scores，PSQI scores，TCM syndrome scores，and HAMA scores compared to pre-treatment levels，with the patterndifferentiation group showing lower scores than the Western medicine group（P<0.05）. The pattern-differentiation group achieved a total effective rate of 92.98% （53/57 cases），surpassing the Western medicine group's rate of 78.95% （45/57 cases）（P<0.05）. Post-treatment levels of serotonin and glutamate decreased in both groups compared to pre-treatment levels，with the pattern-differentiation group showing a greater reduction than the Western medicine group（P<0.05）. Post-treatment levels of gamma-aminobutyric acid（GABA）and melatonin increased in both groups compared to pre-treatment levels，with the pattern-differentiation group showing a greater increase than the Western medicine group（P<0.05）. After treatment，both groups showed reduced sleep latency（SOL）and wake-up time（WASO）compared to pre-treatment levels，with the pattern-differentiation group exhibiting a greater reduction than the Western medicine group（P<0.05）. Following treatment，both groups exhibited increased total sleep time（TST）and sleep efficiency（SE）compared to pre-treatment levels，with the pattern-differentiation group showing greater improvement than the Western medicine group（P<0.05）. The overall adverse reaction rate in the pattern-differentiation group was 5.26% （3/57 cases），compared to 7.02% （4/57 cases）in the Western medicine group，with no statistically significant difference（P>0.05）.

The treatment of heart-kidney Yang deficiency type of insomnia by Fuzi Decoction combined with Guizhi Gancao Longgu Muli Decoction can regulate the neurotransmitters，improve the sleep structure and enhance the clinical efficacy.