Risk of neuropsychiatric adverse events with montelukast combined with inhaled corticosteroids (ICS) in the treatment of asthma in children and adolescents: a systematic review and meta-analysis.

The incidence of NEs was 12.1% in the montelukast plus inhaled corticosteroids group and 8.6% in the inhaled corticosteroids-only group.

This corresponded to approximately 35 additional events per 1000 children (95% CI: -12 to 82).

Sensitivity analyses and risk-of-bias assessments supported the robustness of the findings.

Subgroup analyses suggested possible increases in headache and sleep disturbances, although these differences were not statistically significant.