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Updated: Sep 21, 2025

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
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Montelukast and Nightmares: Further Characterisation Using Data from VigiBase.

Sarah Watson1, Elenor Kaminsky1,2, Henric Taavola1

  • 1Uppsala Monitoring Centre, Box 1051, Uppsala, Sweden.

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|June 1, 2022
PubMed
Summary
This summary is machine-generated.

Montelukast, used for asthma, has been linked to severe nightmares in post-marketing reports, particularly in children. Discontinuing the drug often resolves these adverse events, highlighting the need for ongoing benefit-risk monitoring.

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Area of Science:

  • Pharmacovigilance
  • Neuroscience
  • Pediatric Medicine

Background:

  • Montelukast is prescribed for asthma management.
  • Nightmares are a reported post-marketing adverse drug reaction not detailed in clinical trials.
  • Previous literature on montelukast-induced nightmares lacked comprehensive case information.

Purpose of the Study:

  • To characterize post-marketing adverse drug reactions of nightmares associated with montelukast.
  • To provide additional information to patients and healthcare professionals for safer montelukast use.
  • To understand the impact and nature of montelukast-associated nightmares.

Main Methods:

  • Clinical review of nightmare reports involving montelukast in VigiBase (WHO global database).
  • Analysis of data collected until May 3, 2020.
  • Focus on detailed descriptions and impact of reported nightmares.

Main Results:

  • 1118 reports of montelukast-associated nightmares were analyzed.
  • Many cases reported severe impact on daily life; about half were classified as serious.
  • Nightmares predominantly affected children (two-thirds), especially those aged 5-10 years.
  • Discontinuation of montelukast led to nightmare resolution in most cases, though sometimes delayed.

Conclusions:

  • Montelukast-associated nightmares represent a significant adverse drug reaction with potential severity.
  • Post-marketing surveillance is crucial for characterizing known adverse drug reactions.
  • Continuous monitoring of the montelukast benefit-risk balance is recommended for patient safety.