Abstract:Objective To investigate the therapeutic efficacy of trazodone in Alzheimer's disease (AD) with sleep disorder and its effect on cognitive function, hippocampal volume and daily life ability.Methods A total of 70 patients with AD with sleep disorder seeking medical treatment in our hospital from October 2018 to October 2019 were selected and randomly divided into observation group (35 patients, oral administration of donepezil and trazodone) and control group (35 patients, oral administration of donepezil and zolpidem). Magnetic resonance imaging (MRI) scans were performed and hippocampal volume was calculated. The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Activities of Daily Living (ADL) were used to assess patients' cognitive level and daily living ability. Polysomnogram (PSG) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the quality of sleep and the therapeutic efficacy.Results The improvement of total sleep time and sleep efficiency after treatment in the observation group was higher than that in the control group, while the decrease in sleep latency and number of awakenings after treatment was lower in the observation group compared with the control group (P < 0.05). The volume difference of left hippocampal head before and after treatment in the observation group was higher than that in the control group (P < 0.05), whereas the volume difference of the left hippocampal body and tail, and the right hippocampal head, body and tail before and after the treatment did not differ between the two groups (P > 0.05). The differences of MMSE, MoCA and ADL scores before and after treatment were higher in observation group than those in control group (P < 0.05). The curative effect of the observation group was significantly better than that of the control group (P < 0.05). There was no difference in the overall incidence of adverse reactions between the two groups (P > 0.05).Conclusions Trazodone combined with donepezil can significantly improve the sleep quality, enhance the cognitive function, and ameliorate the left hippocampal head atrophy in patients suffering from AD with sleep disorder. Besides, it is well-tolerated and worth further application in clinical practice.