See the DrugPatentWatch profile for singulair
Does Singulair Cause Mood Changes?
Yes, Singulair (montelukast) carries warnings for neuropsychiatric events, including mood changes like agitation, anxiety, depression, and irritability. The FDA added a Boxed Warning in 2020 after post-marketing reports linked it to serious mental health effects, including suicidal thoughts and behavior in some patients.[1][2]
Patients have reported symptoms such as mood swings, depression, and aggression, sometimes appearing soon after starting the drug. These effects prompted the FDA to require neuropsychiatric event labeling and led to lawsuits alleging inadequate warnings.[3]
What Do Clinical Trials and FDA Data Show?
Pre-approval trials showed low rates of psychiatric side effects (about 1-2% for mood-related issues), but real-world data revealed rarer severe cases. From 1998-2018, the FDA's database logged over 9,000 neuropsychiatric events, including 82 suicides and 230 suicide attempts tied to montelukast.[4] No direct causation is proven in all cases, but the risk is real enough for warnings on mood changes, especially in children and adolescents.[1]
Who Is Most at Risk?
Children and young adults face higher reports of mood changes, with symptoms like sleep disturbances or aggression resolving after stopping the drug in many instances. Those with a history of mental health issues should use caution; doctors often monitor closely or switch alternatives.[2][5]
How Common Are These Mood Changes?
Exact rates are unclear due to underreporting, but neuropsychiatric events occur in less than 1% of users based on trials. Post-marketing surveillance shows they can happen at any dose, even after short-term use, and most improve upon discontinuation.[4]
What Should Patients Do If Experiencing Mood Changes?
Stop Singulair and contact a doctor immediately if mood shifts, depression, or unusual behavior occur. The FDA urges reporting to its MedWatch program. Never quit abruptly without medical advice to avoid asthma rebound.[1][2]
Alternatives to Singulair for Asthma or Allergies
For leukotriene blockers, options include generic montelukast alternatives or Accolate (zafirlukast), which has fewer neuropsychiatric reports but risks hepatotoxicity. Inhaled corticosteroids like Flovent or combination inhalers (Advair) are first-line for many, with better safety profiles for mood.[5]
Sources:
[1]: FDA Drug Safety Communication on Montelukast
[2]: Singulair Prescribing Information
[3]: FDA Adverse Event Reporting System (FAERS) Public Dashboard
[4]: Byrne et al., Pediatrics (2019) on Montelukast Neurobehavioral Effects
[5]: American Academy of Allergy, Asthma & Immunology Guidelines