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Introduction <p>This systematic review and meta-analysis aimed to summarize the incidence of sleepiness in patients who used newer-generation antihistamines.</p> Methods <p>CINAHL Complete, Medline, Scopus, ScienceDirect, and Google Scholar were systematically searched from inception to July 2025. The pairwise meta-analysis of the sleepiness incidence was conducted using a binary random-effects model. The network meta-analysis was performed using a random-effects model in a frequentist framework. Heterogeneity was evaluated using the I<sup>2</sup> statistic. </p> Results <p>One hundred and sixty-three studies were included in the systematic review and meta-analysis. We found that 1.3% (95% CI: 1.0-1.6%, I<sup>2</sup> = 40.45) of those taking a placebo reported sleepiness. The least-sedating antihistamine in adults was bilastine 20 mg (prevalence = 1.6%; 95% CI: 0.7-2.5%, I<sup>2</sup> = 47.83). Data from network meta-analysis also supported that bilastine 20 mg has the least sedative effect (relative risk = 1.06; 95%CI: 0.67-1.69). At their usual therapeutic dose, bepotastine 20 mg, bilastine 20 mg, desloratadine 5 mg, and fexofenadine 120 mg-180 mg had a prevalence of sleepiness of less than 10% and not significantly different from placebos (<i>p</i> &gt; 0.05).</p> Conclusion <p>All nonsedating antihistamines administered at their usual doses have a higher prevalence of sleepiness compared to the placebo. However, most of the prevalence values are not statistically different from those of the placebo. </p>

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The incidence of sleepiness in newer-generation antihistamine users: a systematic review and network meta-analysis

  • 期刊论文

  • 发表日期：

    2026年7月22日

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  • Nattawut Leelakanok,
  • Anchana Pongpun,
  • Bannawich Sapapsap,
  • Nattanich Jirathawonkul,
  • Nakarin Asawadachachanyoot,
  • Parin Mama,
  • Kansak Boonpattharatthiti,
  • Charinrat Saechan,
  • Natakorn Nokchan,
  • Nattinee Leelakanok,
  • Arpa Petchsomrit

摘要

Introduction

This systematic review and meta-analysis aimed to summarize the incidence of sleepiness in patients who used newer-generation antihistamines.

Methods

CINAHL Complete, Medline, Scopus, ScienceDirect, and Google Scholar were systematically searched from inception to July 2025. The pairwise meta-analysis of the sleepiness incidence was conducted using a binary random-effects model. The network meta-analysis was performed using a random-effects model in a frequentist framework. Heterogeneity was evaluated using the I2 statistic.

Results

One hundred and sixty-three studies were included in the systematic review and meta-analysis. We found that 1.3% (95% CI: 1.0-1.6%, I2 = 40.45) of those taking a placebo reported sleepiness. The least-sedating antihistamine in adults was bilastine 20 mg (prevalence = 1.6%; 95% CI: 0.7-2.5%, I2 = 47.83). Data from network meta-analysis also supported that bilastine 20 mg has the least sedative effect (relative risk = 1.06; 95%CI: 0.67-1.69). At their usual therapeutic dose, bepotastine 20 mg, bilastine 20 mg, desloratadine 5 mg, and fexofenadine 120 mg-180 mg had a prevalence of sleepiness of less than 10% and not significantly different from placebos (p > 0.05).

Conclusion

All nonsedating antihistamines administered at their usual doses have a higher prevalence of sleepiness compared to the placebo. However, most of the prevalence values are not statistically different from those of the placebo.