Montelukast and Neuropsychiatric Adverse Events

Clinical Guidance

The European Respiratory Society acknowledges that evidence of the association between montelukast and neuropsychiatric adverse events is conflicting, including suicidal ideation and behavior 1, 2
The European Respiratory Society provides clear guidance that montelukast should not be used as first-line therapy for chronic rhinosinusitis or asthma, and should only be considered when patients do not tolerate nasal corticosteroids 2
The American Academy of Family Physicians indicates that montelukast is primarily for asthma as alternative therapy for mild persistent asthma 3
Patients must be instructed to immediately notify their prescriber if neuropsychiatric changes occur, and to understand that montelukast is not for acute asthma attacks 3
The American Journal of Respiratory and Critical Care Medicine recommends that patients should continue taking montelukast daily even when asymptomatic 4
The European Respiratory Society recommends screening for pre-existing psychiatric conditions before initiating therapy, and active surveillance for mood changes, sleep disturbances, behavioral changes, or suicidal thoughts at each follow-up 4

The European Respiratory Society recommends considering alternative therapies, such as inhaled corticosteroids, which have superior efficacy profiles without the risks associated with montelukast 3
Montelukast should be discontinued immediately if the patient develops suicidal thinking or behavior, new or worsening depression or anxiety, agitation or aggressive behavior, hallucinations or psychotic symptoms, or significant sleep disturbances or dream abnormalities 3

Depression was reported in approximately 1% of patients in clinical trials, according to the American Academy of Dermatology 5

The American Academy of Allergy and Clinical Immunology recommends inhaled corticosteroids as more effective and safer first-line therapy for persistent asthma 6
The European Respiratory Society and the EPOS2020 steering group recommend montelukast only when patients do not tolerate nasal corticosteroids, and do not advise adding montelukast to nasal corticosteroids due to lack of demonstrated benefit, as reported in Rhinology 7