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Objective <p>To systematically evaluate the clinical efficacy of lemborexant (LEM) and daridorexant (DAR) for the treatment of insomnia, including the difference in efficacy and safety.</p> Methods <p>In this systematic review and meta-analysis, we searched the randomized controlled trials (RCTs) comparing the efficacy and safety of LEM and DAR in patients with insomnia in five databases from database inception to Mar 16, 2024. We evaluate the quality of studies. Besides, we perform the meta-analysis and detect publication bias.</p> Results <p>A total of 8 RCTs with 5077 patients were included in this study, including 2239 in the LEM treatment group, 1397 in the DAR treatment group, and 1441 in the placebo (PBO) control group. Both LEM and DAR significantly improved sleep outcomes compared to placebo. LEM was more effective in reducing the time of wake after sleep onset (WASO) (MD, -45.15; 95% CI: -51.75 to -38.56; <i>P</i> &lt; 0.001) and improving subjective sleep onset latency (sSOL) (MD, -25.01; 95% CI: -28.58 to -21.44; <i>P</i> &lt; 0.001) than DAR (WASO: MD: -12.6; 95% CI: -18.71 to -6.5; <i>P</i> &lt; 0.001; sSOL: MD, -2.33; 95% CI: -7.1 to 2.45; <i>P</i> = 0.24). In terms of dosing, DAR at 50&#xa0;mg demonstrated superior efficacy compared to the 5&#xa0;mg, 10&#xa0;mg, and 25&#xa0;mg doses, indicating a dose-dependent effect. The efficacy of LEM was consistent across the 5&#xa0;mg and 10&#xa0;mg doses. Safety profiles revealed that DAR (RR, 1.16; 95% CI: 1.03 to 1.29; <i>P</i> = 0.01) treatment was associated with higher rates of treatment-emergent adverse events (TEAEs) compared to placebo, particularly at the 25&#xa0;mg dose (RR, 1.15; 95% CI: 1.02 to 1.31; <i>P</i> = 0.03), while LEM (RR, 1.21; 95% CI: 0.98 to 1.50; <i>P</i> = 0.08) showed no significant difference in TEAEs rates compared to placebo. However, LEM (RR, 5.62; 95% CI: 2.92 to 10.83; <i>P</i> &lt; 0.001) was associated with a higher risk of somnolence compared to DAR (RR, 1.55; 95% CI: 0.86 to 2.81; <i>P</i> = 0.15). The overall quality of the included studies was moderate to high based on the risk of bias assessment.</p> Conclusion <p>Both LEM and DAR are effective and generally safe options for the treatment of insomnia, with LEM showing greater efficacy in improving WASO and sSOL. The choice between LEM and DAR should consider individual patient needs, including the risk of daytime drowsiness and other adverse events. Further direct comparative trials are needed to confirm these findings and inform clinical decision-making.</p>

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Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2025年3月25日

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  • Ming Tang,
  • Ziyi Shen,
  • Peilu Yu,
  • Meiling Yu,
  • Xiaoqiong Tong,
  • Guohui Jiang

摘要

Objective

To systematically evaluate the clinical efficacy of lemborexant (LEM) and daridorexant (DAR) for the treatment of insomnia, including the difference in efficacy and safety.

Methods

In this systematic review and meta-analysis, we searched the randomized controlled trials (RCTs) comparing the efficacy and safety of LEM and DAR in patients with insomnia in five databases from database inception to Mar 16, 2024. We evaluate the quality of studies. Besides, we perform the meta-analysis and detect publication bias.

Results

A total of 8 RCTs with 5077 patients were included in this study, including 2239 in the LEM treatment group, 1397 in the DAR treatment group, and 1441 in the placebo (PBO) control group. Both LEM and DAR significantly improved sleep outcomes compared to placebo. LEM was more effective in reducing the time of wake after sleep onset (WASO) (MD, -45.15; 95% CI: -51.75 to -38.56; P < 0.001) and improving subjective sleep onset latency (sSOL) (MD, -25.01; 95% CI: -28.58 to -21.44; P < 0.001) than DAR (WASO: MD: -12.6; 95% CI: -18.71 to -6.5; P < 0.001; sSOL: MD, -2.33; 95% CI: -7.1 to 2.45; P = 0.24). In terms of dosing, DAR at 50 mg demonstrated superior efficacy compared to the 5 mg, 10 mg, and 25 mg doses, indicating a dose-dependent effect. The efficacy of LEM was consistent across the 5 mg and 10 mg doses. Safety profiles revealed that DAR (RR, 1.16; 95% CI: 1.03 to 1.29; P = 0.01) treatment was associated with higher rates of treatment-emergent adverse events (TEAEs) compared to placebo, particularly at the 25 mg dose (RR, 1.15; 95% CI: 1.02 to 1.31; P = 0.03), while LEM (RR, 1.21; 95% CI: 0.98 to 1.50; P = 0.08) showed no significant difference in TEAEs rates compared to placebo. However, LEM (RR, 5.62; 95% CI: 2.92 to 10.83; P < 0.001) was associated with a higher risk of somnolence compared to DAR (RR, 1.55; 95% CI: 0.86 to 2.81; P = 0.15). The overall quality of the included studies was moderate to high based on the risk of bias assessment.

Conclusion

Both LEM and DAR are effective and generally safe options for the treatment of insomnia, with LEM showing greater efficacy in improving WASO and sSOL. The choice between LEM and DAR should consider individual patient needs, including the risk of daytime drowsiness and other adverse events. Further direct comparative trials are needed to confirm these findings and inform clinical decision-making.