From the FDA Drug Label
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Behavior and mood-related changes have been reported: agitation including aggressive behavior or hostility, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, sleep walking, suicidal thoughts and actions (including suicide), tremor, trouble sleeping Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor
Singulair and Suicide: There is a reported association between Singulair (montelukast) and suicidal thinking and behavior, including suicide. Patients and prescribers should be alert for neuropsychiatric events, including suicidal thoughts and actions. If such events occur, prescribers should carefully evaluate the risks and benefits of continuing treatment with Singulair 1, 1, 1.
From the Research
Singulair (montelukast) has been associated with an increased risk of neuropsychiatric side effects, including suicidal thoughts and behaviors, and patients taking this medication should be closely monitored for these adverse effects 2.
Key Points to Consider
- The FDA has strengthened its warning about the mental health side effects of Singulair, requiring a boxed warning on the medication 2.
- Patients taking Singulair should be vigilant for mood changes, depression, agitation, aggressive behavior, hallucinations, attention problems, and suicidal thoughts or behaviors.
- These side effects can occur at any time during treatment but may be more common when starting or stopping the medication.
- If patients experience any of these symptoms while taking Singulair, they should contact their healthcare provider immediately and not stop taking the medication without medical guidance.
Clinical Considerations
- For patients with a history of mental health conditions, the risks and benefits of Singulair should be carefully weighed, and alternative asthma or allergy medications might be more appropriate 2.
- The mechanism behind these neuropsychiatric effects isn't fully understood but may relate to how leukotriene modifiers affect brain chemistry.
- Regular monitoring and open communication with the healthcare provider are essential while using this medication.
Evidence-Based Recommendations
- The most recent and highest quality study on this topic is from 2020, which highlights the importance of monitoring for neuropsychiatric side effects in patients taking Singulair 2.
- Other studies have also demonstrated the efficacy and safety of montelukast in treating allergic rhinitis and asthma, but the risk of neuropsychiatric side effects must be carefully considered 3, 4, 5, 6.