Observational studyJournal of paediatrics and child health2025
Potentially Overlooked Risk for Neuropsychiatric Symptoms in Children: Montelukast Treatment.
Observational study in Journal of paediatrics and child health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- [Sleep disorders associated with montelukast in children with respiratory allergy].Revista medica del Instituto Mexicano del Seguro Social · 2026Article
- Natural medicines for asthma management: mechanisms aligned with endotypes and multi-dimensional intervention.Frontiers in pharmacology · 2026Review
- NLRP3 inflammasome expression in pediatric asthma: sputum-based insights, inflammatory mechanisms, and targeted therapeutic strategies.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2025Review
- Potentially Overlooked Risk for Neuropsychiatric Symptoms in Children: Montelukast Treatment.Journal of paediatrics and child health · 2025Observational
Corrections and comments
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Authors and funding
43 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMontelukast is a leukotriene receptor antagonist commonly used in allergic diseases. In this study, we investigated the frequency, severity and risk factors for neuropsychiatric side effects and sleep disorders associated with montelukast in children.
methodChildren aged 6 months to 17 years prescribed montelukast for allergic rhinitis or asthma at 31 Paediatric Allergy and Immunology centres were enrolled in this cohort study. At enrollment, sociodemographic characteristics, prior diagnoses of neuropsychiatric diseases or sleep disorders, and indications for montelukast treatment were recorded, and the primary caregivers completed a baseline questionnaire about neuropsychiatric symptoms (insomnia, nightmares and depressed mood) of their children. All participants were followed up for 1 month, and a post-treatment follow-up questionnaire on neuropsychiatric symptoms was completed at the end of this period. Moreover, caregivers were instructed to contact the clinic if neuropsychiatric side effects or sleep disorders were observed during this period.
resultsTotal of 1163 children were enrolled. There was a significant increase in the frequency of insomnia, nightmares, night terrors, drowsiness, behavioural problems, irritability, depressive mood, agitation, anxiety, hyperactivity, learning difficulties and headache during the 1 month period after montelukast treatment compared to the previous 1 month (p < 0.001 for all). Overall, caregiver reports of neuropsychiatric symptoms in children increased from 172 (14.8%) to 399 (34.3%) after 1 month of montelukast treatment (p < 0.001).
conclusionsMontelukast treatment increases the risk of neuropsychiatric symptoms and sleep disorders in children with allergic diseases, especially if there is concomitant use of antihistamines.
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Registered trials
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