To observe the clinical efficacy and safety of agomelatine combined with paroxetine tablets in patients with depression and insomnia, and its effects on neurotransmitter levels and sleep.

The patients with depression and insomnia were divided into control group and treatment group, according to random number table. Control group was treated with paroxetine tablets 20 mg, oral, treatment course was 8 weeks. Treatment group was treated with agomelatine 25 mg and paroxetine tablets 20 mg, once a day, treatment course was 8 weeks. The Hamilton depression rating scale (HAMD), Montreal cognitive assessment scale (MoCA), neurotransmitters [norepinephrine (NE), 5-hydroxytryptamine (5-HT), dopamine (DA)], Pittsburgh sleep quality index (PSQI) and incidence of adverse drug reactions between two groups were compared.

Treatment group was enrolled 60 cases; control group was enrolled 60 cases. After 8 weeks of treatment, the HAMD in treatment group and control group were (17.33±1.54) and (21.19±1.87) scores; MoCA were (29.01±0.19) and (28.52±0.21) scores; NE levels were (65.56±4.63) and (53.74±4.52) ng·mL^-1; 5-HT levels were (165.82±7.17) and (149.63±8.48) ng·mL^-1; DA levels were (582.73±17.52) and (543.85±20.38) ng·mL^-1, sleep latency were (1.09±0.12) and (1.53±0.15) scores; sleep efficiency were (1.12±0.17) and (1.58±0.20) scores; hypnotic drug were (1.01±0.13) and (1.42±0.15) scores; subjective sleep quality were (1.14±0.10) and (1.62±0.16) scorse; sleep persistence were (1.16±0.11) and (1.55±0.13) scores; the score for sleep disorders were (1.07±0.14) and (1.52±0.17) scores; daytime functional disorders were (0.99±0.16) and (1.51±0.18) scores, all with statistically significant difference (all P<0.05). The adverse drug reactions in treatment group and control group were 11.67% and 8.33%, with no statistically significant differences (P>0.05).

Administration of agomelatine and paroxetine tablets to patients with depression and insomnia can improve depressive symptoms, cognitive function, sleep conditions, regulate the expression of neurotransmitters such as NE and 5-HT, and has good safety.