Evidence Hub

Montelukast: risk of mental disorders vs. efficacy–a meta-analysis

Marharyta Sobczak, Rafał Pawliczak

Frontiers in Pharmacology, 2025

3 citations

Abstract

Background: Montelukast, a selective leukotriene receptor antagonist, is widely used in the treatment of bronchial asthma and allergic rhinitis (AR). Although it is a well-tolerated drug, there are reports of possible central nervous system side effects, including, for example, mood changes and suicidal thoughts. Therefore, we conducted a meta-analysis to test the effects of montelukast on the mental health of patients taking montelukast and to test its effectiveness in treating asthma and AR. Methods: PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials databases were searched to find articles of control-compared randomized clinical trials, which investigated the efficacy of montelukast treatment as well as articles about mental disorders after this treatment. The relative risk with 95% confidence interval (CI) and the standardized mean difference with 95% CI were calculated to compare the effect. A random effects model was used to calculate effect sizes. Results: = 0%) without differences between subgroups. Meta-analysis showed the different efficacy of montelukast against asthma and AR symptoms in comparison to placebo and other drugs. Conclusion: In terms of treating asthma and allergic rhinitis, montelukast shows comparable efficacy to other drugs, such as inhaled corticosteroids or second-generation antihistamines. Furthermore, montelukast was associated with a modestly increased risk of anxiety, while no consistent evidence was found for an…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

Related studies

Go deeper in Evidence Hub

Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.

Open this study Sign up free