Objective:To investigate the clinical effect and safety of agomelatine combined with eszopiclone in the treatment of epilepsy complicated by insomnia,and to assess the feasibility of this treatment regimen.Methods:69 epileptic patients with insomnia were collected in the outpatient of the department of neurology,the First Affiliated Hospital of Shanxi Medical University from December 2021 to October 2022.Patients were randomly divided into control group(34cases)and observation group(35 cases).The patients in control group were given eszopiclone,1.5~3 mg(3~5times/week).The patients in observation group were given agomelatine 25 mg(1 time/day)and eszopiclone 1.5~3 mg(3~5times/week).Patients in both groups maintained their original anti-seizure medication treatment regimen for 12 weeks during the study.PSQI,ISI,PHQ-9 and GAD-7 were used to compare differences in subjective sleep quality,insomnia severity,depression and anxiety symptoms before treatment and at the end of 4 and 12 weeks of treatment.The change of seizure frequency before and after treatment was statistically evaluated to assess epilepsy control.The adverse effects after medication were recorded in both groups.Results:1.Comparison of sleep : After 4 weeks and 12 weeks of treatment,the PSQI scores of both groups were significantly lower than those before treatment(P < 0.05).The difference between both groups was significant(P < 0.05).After drug treatment,the ISI scores of both groups were significantly lower than those before treatment(P < 0.05),and the difference between both groups was significant(P < 0.05).2.Comparison of depression and anxiety: After 4 weeks and 12 weeks of treatment,PHQ-9 and GAD-7 scores of two groups were significantly lower than those before treatment(P < 0.05).The differences between two groups were also significant(P <0.05).3.Comparison of seizure frequency: The seizure frequency of both groups decreased significantly after 12 weeks of treatment,with a statistically significant difference(P<0.05).There was no statistically significant difference in seizure frequency between both groups before and after treatment(P>0.05).4.Comparison of adverse effects: Adverse reactions during treatment in control group included dizziness(1 case),drowsiness(2 cases),and gastrointestinal discomfort(1 case);Adverse reactions in observation group included drowsiness(2 cases),gastrointestinal discomfort(2 cases),and abnormal liver function(1 case).No significant difference in overall adverse reactions was observed between both groups.(P>0.05).Conclusion:1.Compared with eszopiclone alone,agomelatine combined with eszopiclone improve subjective sleep quality,insomnia severity,depression and anxiety symptoms of patients more significantly,and the effect is long-lasting.2.Agomelatine combined with eszopiclone and eszopiclone alone reduced seizure frequency,and there was no significant difference between the two treatment regimens.3.There was no significant difference in the safety of the two treatment regimens,but liver function needed to be monitored when agomelatine was used. |