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Background: The United States Food and Drug Administration issued a black box warning on the mental health adverse effects of montelukast in 2020. Age-related effects on the risk of developing specific neuropsychiatric events in montelukast users remain largely unknown. Objective: To describe the risk of neuropsychiatric events associated with montelukast in adults and children with asthma. Methods: A systematic search of all studies investigating neuropsychiatric events in montelukast users was performed in PubMed, the Cochrane Library and Embase from inception to 7 September 2022. Animal studies and conference abstracts were excluded. Results: 59 studies (21 pharmacovigilance studies, four reviews from 172 randomised controlled trials, 20 observational studies, 10 case reports and four case series) evaluating neuropsychiatric events in patients with asthma on montelukast were reviewed. No significant association was shown between montelukast and suicide-related events in six of the observational studies. No association was found for depression as defined by the International Classification of Diseases 10th revision codes in three observational studies and a review of randomised clinical trials. However, findings from four studies using antidepressant prescriptions as the outcome identified significant associations. Consistent with nine pharmacovigilance studies, two large-scale observational studies revealed possible associations of montelukast with anxiety and sleeping disorders in adult patients with asthma, respectively. However, the results were not replicated in two observational studies on children. Conclusion: Montelukast is not associated with suicide- and depression-related events in asthma patients. Older adults may be particularly susceptible to anxiety and sleeping disorders. [ABSTRACT FROM AUTHOR]

Background: The United States Food and Drug Administration issued a black box warning on the mental health adverse effects of montelukast in 2020. Age-related effects on the risk of developing specific neuropsychiatric events in montelukast users remain largely unknown., Objective: To describe the risk of neuropsychiatric events associated with montelukast in adults and children with asthma., Methods: A systematic search of all studies investigating neuropsychiatric events in montelukast users was performed in PubMed, the Cochrane Library and Embase from inception to 7 September 2022. Animal studies and conference abstracts were excluded., Results: 59 studies (21 pharmacovigilance studies, four reviews from 172 randomised controlled trials, 20 observational studies, 10 case reports and four case series) evaluating neuropsychiatric events in patients with asthma on montelukast were reviewed. No significant association was shown between montelukast and suicide-related events in six of the observational studies. No association was found for depression as defined by the International Classification of Diseases 10 th revision codes in three observational studies and a review of randomised clinical trials. However, findings from four studies using antidepressant prescriptions as the outcome identified significant associations. Consistent with nine pharmacovigilance studies, two large-scale observational studies revealed possible associations of montelukast with anxiety and sleeping disorders in adult patients with asthma, respectively. However, the results were not replicated in two observational studies on children., Conclusion: Montelukast is not associated with suicide- and depression-related events in asthma patients. Older adults may be particularly susceptible to anxiety and sleeping disorders., Competing Interests: Conflict of interest: C.W.H. Lo received a student internship award by the University of Hong Kong under the Undergraduate Research Fellowship Programme. I.C.K. Wong received grants from the Food and Health Bureau of the Government of Hong Kong Special Administrative Region (HKSAR); funding from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong Research Grants Council, the Hong Kong Health and Medical Research Fund in Hong Kong, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia for pharmacoepidemiology to the University of Hong Kong, outside submitted work; consulting fees from IQVIA for offering advisory services on pharmacoepidemiology studies and payment from the Appeal Court in Hong Kong for expert testimony on the effects of cannabis outside submitted work; and salary as an independent nonexecutive director of Jacobson Medical in Hong Kong. E.W.Y. Chan received grants from the Health Bureau of the Government of the HKSAR, Hong Kong Research Grants Council, National Natural Science Fund of China, AstraZeneca, Novartis, RGA Reinsurance Company, Pfizer and Narcotics Division of the Security Bureau of HKSAR; consulting fees from Pfizer, Novartis and AstraZeneca; and travel support from Novartis. E.W.Y. Chan received medical device samples from GlaxoSmithKline Ltd., AstraZeneca, Boehringer Ingelheim and Novartis for teaching purposes. The other authors declare no conflicts of interest., (Copyright ©The authors 2023.)