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

Sobczak M and Pawliczak R (2025)  Front. Pharmacol. 16:1659852. doi: 10.3389/fphar.2025.1659852

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.

Risk of (A) anxiety, (B) depression and (C) suicidal and self-injurious
behaviors,nonfatal self-harm or completed suicides after montelukast
treatmentcompared to control.

Results: Our meta-analysis was based on 4 studies (mental health analysis) and 19 studies (efficacy analysis). We indicated that montelukast treatment was associated with a higher risk of anxiety by 11% (RR = 1.11; 95% CI [1.06; 1.16]; p < 0.0001, I2 = 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 increased risk of depression or suicidal behaviors, considering the limited data.

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