New pooled analysis indicates that montelukast, a common asthma medication for children, could be linked to increased risks of ADHD and behavioural disorders, prompting caution among clinicians and parents.
A new pooled analysis suggests that montelukast, a common asthma controller for children, may carry greater neuropsychiatric risks than inhaled corticosteroids, particularly for attention-deficit/hyperactivity disorder and disruptive behaviour disorders. The study, published in BMC Medicine and led by Xue-Feng Jiao and Anick Bérard, draws on two long-running birth cohorts in the United States and Quebec, and adds to a growing body of work that has kept the drug under scrutiny since the US Food and Drug Administration attached its strongest warning to montelukast in 2020. Recent reviews and cohort studies have also continued to flag possible links between montelukast and sleep problems, though the wider literature remains mixed.
Montelukast, sold for years under the brand name Singulair, is often used because it is simple to take once a day, unlike inhaled corticosteroids, which require proper inhaler technique and regular use. That convenience appears to matter in real life: prescription data show that children who start montelukast are often more likely to stay on treatment than those given inhaled steroids. Yet the latest analysis suggests that ease of use may come with trade-offs. In the pooled results, children who began montelukast after a first asthma diagnosis had a 40% higher risk of being diagnosed with ADHD and a 43% higher risk of oppositional defiant or conduct disorder than those who started on inhaled corticosteroids. The study found no clear difference between the medicines for anxiety or mood disorders.
The findings are notable because earlier research has not always pointed in the same direction. A 2026 systematic review and meta-analysis reported a pooled risk ratio of 1.41 for neuropsychiatric events when montelukast was used alongside inhaled corticosteroids, but it also stressed that the evidence remains uncertain. At the same time, a large nationwide study published in 2025 found no significant difference in neuropsychiatric outcomes between montelukast and long-acting beta-agonists, underscoring how difficult it has been to separate a drug effect from the effects of asthma itself, illness severity and treatment patterns. The new BMC Medicine paper tried to reduce that uncertainty by focusing on children at their first asthma diagnosis and excluding those with prior psychiatric or neurological conditions.
Sleep problems appeared to be the most complicated signal. In Quebec, the risk was markedly higher, while in the US cohort the association was far weaker. The researchers said the difference seemed to reflect asthma severity: most Quebec children had controlled or partly controlled disease, whereas much larger numbers of US children had more severe asthma and used oral steroids during follow-up. When the analysis was narrowed to children with better-controlled asthma, montelukast was linked to more sleep disorders, suggesting that the drug’s effect may be easier to detect when asthma itself is not already disturbing sleep. For parents and clinicians, the practical message is caution rather than panic: montelukast remains useful, but children taking it should be watched closely for insomnia, unusual dreams, sleepwalking, inattention, hyperactivity, irritability and behavioural changes.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
