Abstract
Background
Insomnia disorder is associated with an impairment in cognitive performance. Doxepin and zolpidem have been found to be effective in improving sleep. In this study, we aimed to compare the effects of doxepin and zolpidem on sleep structure and executive function in patients with insomnia disorder.
Methods
Patients with primary insomnia were randomly assigned to receive doxepin 6 mg/day orally or zolpidem 5–10 mg/day orally. Polysomnography (PSG) and the Pittsburgh Sleep Quality Index (PSQI) were used at baseline and after the 8-week treatment to compare clinical efficacy in the two groups. Safety was assessed using the Treatment Emergent Symptom Scale (TESS). Executive function was evaluated using the Wisconsin sorting card test (WSCT).
Results
Of 120 patients enrolled in the study, 60 participants were assigned to each group. A total of 109 participants (53 in the doxepin group and 56 in the zolpidem group) completed the study. After treatment, the wake after sleep onset (WASO) and total sleep time (TST) values in the doxepin group were 80.3 ± 21.4 min and 378.9 ± 21.9 min, respectively, which were significantly better than those in the zolpidem group (132.9 ± 26.5 min and 333.2 ± 24.2 min, respectively; (P < 0.05)). The sleep onset latency (SOL) value in the zolpidem group (20.3 ± 4.7 min) was significantly better than that in the doxepin group (28.2 ± 5.6 min; P < 0.05). The sleep efficiency (SE) in the doxepin group was 77.8 ± 4.2%, which was significantly better than that in the zolpidem group (68.6 ± 5.0%; P < 0.05). The PSQI score of the doxepin group was 6.1 ± 1.1, which was significantly lower than that in the zolpidem group (7.9 ± 1.9; P < 0.05). The treatment adverse events in the doxepin group was 23.3%, which was significantly higher than that in the zolpidem group (13.3%; P < 0.05). The WSCT showed a significant improvement in persistent errors (PE), random errors (RE), and categories in the two groups after 8-week treatment, and the improvement in RE and the categories was more obvious in the doxepin group (P < 0.05).
Conclusions
Both doxepin and zolpidem were found to be effective in improving sleep quality, but the effects exhibited different patterns. Doxepin improved executive function more effectively than zolpidem in patients with insomnia disorder.
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Data availability
The data that support our findings are available from the corresponding author upon reasonable request.
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Acknowledgements
We thank the patient who participates in our study. We are grateful to the funding of this study.
Funding
Funding for this study was provided by Hangzhou Science and technology development plan project (No. 20180533B81(Li HAN were responsible for collecting clinical data and performing the clinical rating), No. 20160533B30 (Zhenghe YU were responsible for study design and data analysis)), Project for Hangzhou Medical Disciplines of Excellence, Key Project for Hangzhou Medical Disciplines.
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SW and ZY were responsible for study design. LH, LR, YX, WL, LM, YW, LY, and YL were responsible for collecting clinical data and performing the clinical rating. SW and PY were responsible for analysis and manuscript. All authors contributed to and have approved the final manuscript.
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The study was approved by the Ethics Committee of the Hangzhou Seventh People’s Hospital. The purpose and importance of the study were explained to the participant. Informed consent was obtained from all individual participants included in the study.
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Written informed consent was obtained from the patient for publication of this study.
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Yu, Z., Han, L., Yan, P. et al. Doxepin is more effective than zolpidem in improving executive function in patients with insomnia disorder. Sleep Breath (2023). https://doi.org/10.1007/s11325-023-02972-4
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DOI: https://doi.org/10.1007/s11325-023-02972-4