Montelukast (Singulair) and Black patients
Brand names: Singulair
What Montelukast does
Montelukast blocks the cysteinyl leukotriene receptor, reducing bronchial inflammation. It is a once-daily oral tablet sometimes used as an alternative or add-on to inhaled corticosteroids in asthma, and for allergic rhinitis.
What the evidence says for Black patients
Montelukast is modestly effective in asthma — less so than an ICS. GINA and NAEPP guidelines generally position it as a second-line or add-on, not first-line. Two Black-patient issues:
- FDA 2020 boxed warning for serious neuropsychiatric events — depression, suicidality, sleep disturbance, aggression. The signal is not race-differential, but affects a drug widely prescribed to children — and Black children are already less likely to receive adequate mental-health surveillance. If a child on montelukast has new mood or behavioral symptoms, the drug is on the differential.
- A disparities concern: montelukast's appeal is that it's oral (no inhaler) and widely covered. Clinicians sometimes reach for it as a 'simpler' option for patients perceived to have adherence difficulty — bypassing the better-evidence ICS+LABA or ICS-formoterol SMART regimens that Black patients specifically benefit from. Ask whether montelukast is being added because the clinical evidence supports it, or because the clinician is avoiding inhaler teaching.
Common alternatives
Inhaled corticosteroid (fluticasone, budesonide) as first-line controller. ICS+LABA or SMART (Symbicort) for moderate-severe asthma. Tiotropium, biologics (omalizumab, mepolizumab, benralizumab) for severe asthma.
Side effects
- Headache
- GI upset
- Neuropsychiatric: mood change, depression, suicidality — FDA boxed warning; discontinue immediately if these emerge
- Churg-Strauss syndrome (rare, usually when tapering oral steroid)
Factors that affect adherence
Once-daily oral dosing is appealing for adherence. Generic is inexpensive. Every patient (especially children/adolescents) should be counseled on neuropsychiatric side effects at every visit.
Questions to ask your doctor
Bring this list to your next appointment.
- Is my asthma controlled enough to justify the neuropsychiatric risk of montelukast? Have we tried an ICS fully first?
- If my child is on this, what mood/behavior changes should I watch for?
- Can we move to an ICS-based regimen instead?
References
- U.S. Food and Drug Administration. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair). 2020-03-04. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug
- 2020 Focused Updates to the Asthma Management Guidelines (NAEPP). J Allergy Clin Immunol. 2020;146:1217–1270.
- U.S. Food and Drug Administration. Singulair (montelukast sodium) label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020829s071,020830s075,021409s049lbl.pdf
Medical disclaimer
This page is patient education, not prescribing guidance. It summarizes the published evidence about how this medication has been studied in Black patients — it is not a substitute for the judgment of your personal clinician. Never start, stop, or change a prescription based on something you read here. If you have questions about your medication, call your prescriber or pharmacist. For emergencies, call 911.
Read our editorial standards for how we source, review, and update these pages.