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Background <p>Intranasal naloxone is widely used in emergency medicine and community overdose response because it is needle-free and easy to administer, but its comparative effectiveness versus parenteral naloxone remains uncertain.</p> Objective <p>To compare the effectiveness and safety of intranasal naloxone versus intramuscular or intravenous naloxone for reversal of suspected or confirmed opioid overdose using evidence from randomized controlled trials.</p> Methods <p>We conducted a systematic review and meta-analysis reported in accordance with PRISMA 2020. PubMed, Web of Science, and Scopus were searched from inception to November 30, 2025, without language or date restrictions. Randomized controlled trials comparing intranasal naloxone with intramuscular or intravenous naloxone for suspected or confirmed opioid overdose were eligible; observational studies, case series, case reports, and non-randomized trials were excluded. Random-effects meta-analyses used restricted maximum likelihood estimation with Hartung-Knapp-Sidik-Jonkman adjustment. Risk of bias was assessed with RoB 2 and certainty of evidence with GRADE. Registration: PROSPERO CRD420261285816 (submitted).</p> Results <p>Six randomized trials involving 846 analyzed participants were included: four prehospital or ambulance-based trials, one emergency department trial, and one controlled fentanyl-induced apnea crossover trial providing indirect evidence. Compared with intramuscular or intravenous naloxone, intranasal naloxone was associated with longer time to response (3 trials, 287 participants; MD 1.44&#xa0;min, 95% CI 0.80 to 2.07; low-certainty evidence), greater need for rescue naloxone (5 trials, 767 participants; RR 2.80, 95% CI 1.92 to 4.09; moderate-certainty evidence), and lower initial treatment success (3 trials, 528 participants; RR 0.83, 95% CI 0.77 to 0.91; moderate-certainty evidence). Adverse events were reported inconsistently and were summarized qualitatively.</p> Conclusions <p>Intranasal naloxone remains an important harm-reduction intervention, but current randomized evidence does not establish equivalence to parenteral naloxone. Intranasal administration may be associated with slower or less reliable initial reversal and greater rescue-dose requirement, although certainty is limited by risk of bias, indirectness, and imprecision.</p>

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Intranasal Naloxone Versus Intramuscular or Intravenous Naloxone for Opioid Overdose Reversal: a Systematic Review and Meta-Analysis of Randomized Trials

  • 期刊论文

  • 发表日期：

    2026年7月8日

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  • Yousef Mohamed Alsayed,
  • Mohamed Wagdy,
  • Yazan Jawad Janazreh,
  • Azza Abdelmegid,
  • Wala Elzain,
  • Youssef Heikal,
  • Hussein Ali Jawad,
  • Abdullah Zeyad Hameed Al-Tuaama

摘要

Background

Intranasal naloxone is widely used in emergency medicine and community overdose response because it is needle-free and easy to administer, but its comparative effectiveness versus parenteral naloxone remains uncertain.

Objective

To compare the effectiveness and safety of intranasal naloxone versus intramuscular or intravenous naloxone for reversal of suspected or confirmed opioid overdose using evidence from randomized controlled trials.

Methods

We conducted a systematic review and meta-analysis reported in accordance with PRISMA 2020. PubMed, Web of Science, and Scopus were searched from inception to November 30, 2025, without language or date restrictions. Randomized controlled trials comparing intranasal naloxone with intramuscular or intravenous naloxone for suspected or confirmed opioid overdose were eligible; observational studies, case series, case reports, and non-randomized trials were excluded. Random-effects meta-analyses used restricted maximum likelihood estimation with Hartung-Knapp-Sidik-Jonkman adjustment. Risk of bias was assessed with RoB 2 and certainty of evidence with GRADE. Registration: PROSPERO CRD420261285816 (submitted).

Results

Six randomized trials involving 846 analyzed participants were included: four prehospital or ambulance-based trials, one emergency department trial, and one controlled fentanyl-induced apnea crossover trial providing indirect evidence. Compared with intramuscular or intravenous naloxone, intranasal naloxone was associated with longer time to response (3 trials, 287 participants; MD 1.44 min, 95% CI 0.80 to 2.07; low-certainty evidence), greater need for rescue naloxone (5 trials, 767 participants; RR 2.80, 95% CI 1.92 to 4.09; moderate-certainty evidence), and lower initial treatment success (3 trials, 528 participants; RR 0.83, 95% CI 0.77 to 0.91; moderate-certainty evidence). Adverse events were reported inconsistently and were summarized qualitatively.

Conclusions

Intranasal naloxone remains an important harm-reduction intervention, but current randomized evidence does not establish equivalence to parenteral naloxone. Intranasal administration may be associated with slower or less reliable initial reversal and greater rescue-dose requirement, although certainty is limited by risk of bias, indirectness, and imprecision.