Does Singulair Cause Mood Swings or Depression?
Singulair (montelukast) carries FDA boxed warnings for serious neuropsychiatric events, including mood swings, depression, agitation, and suicidal thoughts or actions. These risks apply across age groups, with symptoms sometimes appearing after the first dose and persisting even after stopping the drug.[1][2]
The FDA updated the label in 2020 based on post-marketing reports and clinical data showing rare but severe cases, particularly in children and adolescents. Patients or caregivers have reported sudden mood changes, anxiety, hallucinations, and sleep disturbances linked to use.[1][3]
What Do Clinical Studies and Reports Show?
Trials for Singulair's approval showed low rates of psychiatric side effects (e.g., 1-2% for agitation or depression vs. placebo), but real-world data revealed underreporting. A 2020 FDA review analyzed over 9,000 neuropsychiatric events, including 82 suicides or attempts, leading to the warning. No direct causation is proven for all cases, but the link prompted mandatory provider discussions before prescribing.[2][4]
Who Is Most at Risk?
Children under 18 face higher reporting rates, with symptoms like irritability or mood swings appearing quickly. Adults report depression or aggression less frequently, but risks increase with asthma severity or concurrent mental health issues. Discontinue use if symptoms emerge and seek immediate medical help.[1][3]
What Should Patients Do If Symptoms Appear?
Stop Singulair and contact a doctor right away—do not wait for the next dose. Monitor for aggression, depression, or unusual behavior, especially in kids. The FDA advises weighing benefits against risks for asthma or allergies, often switching to alternatives like inhaled steroids.[2][5]
Common Alternatives Without These Warnings
Inhaled corticosteroids (e.g., Flovent) or leukotriene alternatives like zafirlukast have lower neuropsychiatric risks but different side effect profiles. For allergies, antihistamines (e.g., Claritin) or nasal sprays (e.g., Flonase) avoid these concerns.[3][6]
What Patients and Parents Are Reporting Online
Forums like Drugs.com and WebMD note user experiences of mood swings resolving after quitting Singulair, with some parents citing school behavior changes in kids. Reviews average 5-6/10, praising allergy relief but flagging mental health effects.[7]
[1]: FDA Drug Safety Communication: Montelukast (Singulair)
[2]: FDA Label for Singulair (montelukast)
[3]: MedlinePlus: Montelukast
[4]: FDA Neuropsychiatric Events Review (2020)
[5]: American Lung Association: Singulair Safety
[6]: Mayo Clinic: Asthma Medications
[7]: Drugs.com: Singulair Reviews