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. Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor
Neuropsychiatric Effects of Montelukast: Montelukast (Singulair) can cause various neuropsychiatric effects in patients with mental health disorders, including:
- Agitation and aggressive behavior
- Anxiousness and depression
- Hallucinations and insomnia
- Irritability and restlessness
- Somnambulism (sleep walking)
- Suicidal thinking and behavior (including suicide)
- Tremor Patients and prescribers should be alert for these neuropsychiatric events, and patients should be instructed to notify their prescriber if these changes occur 1, 1, 1.
From the Research
Montelukast (Singulair) can cause significant neuropsychiatric effects in patients with pre-existing mental health disorders and should be used with caution in these populations. These effects include depression, anxiety, irritability, agitation, aggression, suicidal thoughts, insomnia, nightmares, and behavioral changes, as reported in a recent study 2. The FDA has issued a boxed warning for these serious mental health side effects, particularly highlighting the increased risk of suicidal thoughts and behaviors. Patients with existing mental health conditions may be more vulnerable to these adverse effects due to their altered neurotransmitter function. The mechanism likely involves montelukast's action on leukotriene receptors in the brain, which may influence neuronal signaling pathways involved in mood regulation 3. Some studies have found an association between montelukast and neuropsychiatric adverse events, including anxiety and depression 4, 3, while others have found no significant association 5. However, the most recent and highest quality study found no association between montelukast and the risk of neuropsychiatric adverse events in children 5. Healthcare providers should thoroughly discuss these risks with patients before prescribing, monitor closely for any changes in mood or behavior during treatment, and consider alternative asthma or allergy medications if neuropsychiatric symptoms emerge. Patients should be instructed to immediately report any new or worsening mental health symptoms, and discontinuation of montelukast should be considered if such symptoms occur, with appropriate psychiatric evaluation and alternative asthma/allergy management implemented. Key points to consider when prescribing montelukast to patients with mental health disorders include:
- Monitoring for changes in mood or behavior
- Considering alternative medications if neuropsychiatric symptoms emerge
- Thoroughly discussing the risks and benefits of montelukast with patients
- Instructing patients to report any new or worsening mental health symptoms immediately.