Assessing the Risk of Neuropsychiatric Adverse Events with Montelukast Usage in Children & Adolescents
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on July 16th, 2025
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Montelukast is widely used to manage asthma and allergic rhinitis in children and adolescents. However, recent surveillance data had found an association between montelukast usage and the frequency of neuropsychiatric adverse events. Yet, the mechanism behind this effect is not well understood, but it is hypothesized that the agent can interfere with the hypothalamic-pituitary-adrenal axis. With funding from the Swedish Asthma and Allergy Association, a study was conducted to assess the potential neuropsychiatric side effect of montelukast.
The retrospective cohort study was conducted in Sweden with the data collected between 2007 and 2021. The study included the health records of around 75 thousands young children between the ages of 6 and 17 years old. Of which 25 thousands of them were treated with montelukast, with the remaining used long acting β-agonists. After analysis, the researchers found that there is no significant difference between those treated with montelukast and long-acting β-agonists in the incidence rates of neuropsychiatric adverse events such as anxiety, depression, sleep-related disorders, etc. The author noted other studies that explore similar research questions yield inconsistent results. One study in the United States found no association; another one in Canada found a positive association, and a study in South Korea found mixed association based on age groups.
The retrospective cohort study was conducted in Sweden with the data collected between 2007 and 2021. The study included the health records of around 75 thousands young children between the ages of 6 and 17 years old. Of which 25 thousands of them were treated with montelukast, with the remaining used long acting β-agonists. After analysis, the researchers found that there is no significant difference between those treated with montelukast and long-acting β-agonists in the incidence rates of neuropsychiatric adverse events such as anxiety, depression, sleep-related disorders, etc. The author noted other studies that explore similar research questions yield inconsistent results. One study in the United States found no association; another one in Canada found a positive association, and a study in South Korea found mixed association based on age groups.