Objective To explore the effect of Tiaoren Tongdu acupuncture combined with Shugan Jieyu decoction for patients with insomnia and anxiety disorder. Methods A total of 168 patients with insomnia and anxiety disorder (heart kidney disharmony) treated at Hanzhong Hospital of Traditional Chinese Medicine from January 2021 to June 2024 were selected for the randomized controlled trial, and were divided into groups A, B, C, and D by the random number table method, with 42 cases in each group. In group A, there were 18 males and 24 females; they were (55.12±9.63) years old; the duration of anxiety disorder was 22 (14, 31) months; the duration of insomnia was 34 (20, 48) months. In group B, there were 16 males and 26 females; they were (56.55±10.98) years old; the duration of anxiety disorder was 25 (14, 33) months; the duration of insomnia was 36 (21, 50) months. In group C, there were 15 males and 27 females; they were (54.64±9.27) years old; the duration of anxiety disorder was 24 (12, 32) months; the duration of insomnia was 34 (21, 51) months. In group D, there were 16 males and 26 females; they were (54.83±10.02) years old; the duration of anxiety disorder was 23 (15, 30) months; the duration of insomnia was 32 (20, 47) months. Group A were treated with conventional western medicine, group B with conventional western medicine and Shugan Jieyu decoction, group C with conventional western medicine and Tiaoren Tongdu acupuncture, and group D with conventional western medicine, Tiaoren Tongdu acupuncture, and Shugan Jieyu decoction. The scores of traditional Chinese medicine symptoms, Hamilton Anxiety Scale (HAMA), and Pittsburgh Sleep Quality Index (PSQI) and serum levels of 5-hydroxytryptamine (5-HT), norepinephrine (NE), and dopamine (DA) before and after the treatment, clinical efficacies, and occurrence of adverse reactions were compared between the two groups. Statistical analyses were performed using the χ2 test, rank sum test, t test, one-way analysis of variance, SNK-q test, Kruskal-Wallis H test, and Mann-Whitney U test. Results Six cases were excluded, and 162 were included, including 39 in group A, 41 in group B, 40 in group C, and 42 in group D. After the treatment, the scores of traditional Chinese medicine main symptoms, secondary symptoms, and tongue and pulse, total score of traditional Chinese medicine symptoms, scores of HAMA and PSQI, and serum levels of 5-HT, NE, and DA in group A were 7.92±1.25, 7.38±1.17 points, 2 (0, 2), 16.36±3.36, 9.62±1.42, 8.33±1.54, (133.06±18.74) g/L, (25.31±4.82) μg/L, and (394.49±72.32) mmol/L; those in group B were 7.02±1.06, 6.80±1.06, 1 (0, 2), 14.80±2.81, 8.76±1.31, 7.37±1.41, (145.11±20.36) g/L, (19.99±3.96) μg/L, and (343.19±59.63) mmol/L; those in group C were 6.95±1.03, 6.70±1.01, 1(0, 2), 14.60±2.75, 8.53±1.27, 7.45±1.36, (148.13±20.17) g/L, (20.05±4.03) μg/L, and (340.13±58.49) mmol/L; those in group D were 5.83±0.98, 5.74±0.96, 0(0, 1), 12.38±2.44, 7.02±1.12, 6.79±1.24, (162.74±22.55) g/L, (15.98±3.36) μg/L, and (318.53±50.17) mmol/L; after the treatment, the traditional Chinese medicine main symptom score, secondary symptom score, tongue and pulse score, total score, HAMA score, PSQI score, and serum levels of NE and DA were lower than those before the treatment in all the groups; those in groups B,C, and D were higher than those in group A (all P<0.05); those in group D were higher than those in groups B and C (all P<0.05). The total effective rates of groups A, B, C, and D were 76.92% (30/39), 85.37% (35/41), 87.50% (35/40), and 97.62% (41/42), respectively, and the total effective rate of group D was higher than that of group A (P<0.05). There was no statistical difference in the total incidence rate of adverse reactions between the 4 groups (P>0.05). Conclusion On the basis of conventional western medicine, the effect and safety of applying Tiaoren Tongdu acupuncture and Shugan Jieyu decoction in the treatment of patients with insomnia and anxiety disorder (heart kidney disharmony) can relieve their symptoms and anxiety, improve their sleep quality, and regulate the serum levels of neurotransmitters.