[Effects of paroxetine with or without zolpidem on depression with insomnia: a multi-center randomized comparative study].

Objective: To compare the effects of paroxetine with or without zolpidem on depression with insomnia.

Methods: 229 consecutive outpatients with the diagnosis of major depression based on the CCMD-3 criteria who visited the departments of mental counseling, psychiatric, or neurology in 11 general hospitals the country over during a period of 4 weeks, were randomly allocated into 2 groups: paroxetine + zolpidem group (Group A, treated with paroxetine 10 - 20 mg/d and zolpidem 10 mg/d H. d. for 4 weeks) and paroxetine group (Group B, treated with paroxetine only), among which 221 underwent intention-to-treat analysis and 207 underwent completer analysis (CA). Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Pittsburg sleep quality index (PSQI), and 36-item Short Form Health Survey (SF-36) were used to evaluate the outcomes.

Results: One week after the beginning of treatment the reduction of PSQI score of Group A was 5.7, showing an improvement of sleep quality, significantly higher than that of Group B (1.6), and 4 weeks later the reduction of PSQI of Group A was 9.7 +/- 3.6, significantly higher than that of Group B (6.0 +/- 3.5, both P = 0.000). Four weeks after the beginning of treatment, the HAMD reduction rate of Group A was 68.5%, significantly higher than that of Group B (56.8%, P < 0.01), and the HAMA reduction rate of Group A was 66.2%, significantly higher than that of Group B (57.1%, P < 0.01), and the SF-36 score of Group A was 66 +/- 19 (last observation carry forward analysis) or 67 +/- 19 (CA), significantly higher than those of Group B (38 +/- 16 or 67 +/- 19 respectively, both P = 0.000).

Conclusion: selective serotonin reuptake inhibitor antidepressant combined with hypnotic augments the effects of antidepressant on the depressive and anxiety symptoms.