From the Guidelines
Montelukast (Singulair) is associated with a risk of psychiatric side effects, including mood changes, depression, anxiety, agitation, sleep disturbances, and in rare cases, suicidal thoughts or behaviors, as evidenced by the FDA's boxed warning 1. The risk of psychiatric side effects with montelukast is a significant concern, particularly in patients with a history of psychiatric disorders. Key points to consider include:
- Montelukast can cross the blood-brain barrier and affect leukotriene receptors in the brain, potentially influencing neurotransmitter systems involved in mood regulation 1.
- Patients should be monitored closely for any mood or behavior changes, especially during the first weeks of treatment or after dose changes.
- If psychiatric symptoms develop, discontinuation of Singulair should be considered, with the benefits of continued treatment weighed against these risks.
- Alternative asthma or allergy medications may be considered for patients with a history of psychiatric disorders or those who develop these symptoms while taking Singulair. Some important considerations when prescribing montelukast include:
- Informing patients and caregivers about the potential psychiatric side effects before starting treatment
- Instructing patients to report any concerning changes promptly to their healthcare provider
- Weighing the benefits of montelukast against the potential risks, particularly in patients with a history of psychiatric disorders 1.
From the FDA Drug Label
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
The risk of psychiatric side effects associated with Montelukast (Singulair) includes:
- Agitation and aggressive behavior
- Anxiety and depression
- Hallucinations and insomnia
- Irritability and restlessness
- Suicidal thoughts and behavior These side effects have been reported in patients taking SINGULAIR, and patients should be monitored for any changes in behavior or mood while taking this medication 2, 3.
From the Research
Psychiatric Side Effects of Montelukast
The risk of psychiatric side effects associated with Montelukast (Singulair) is a concern that has been investigated in several studies. Some of the key findings include:
- Sleep disturbances, agitation, pain, and hyperactivity were observed in children taking montelukast 4
- In adults, montelukast was well tolerated, with adverse drug reactions occurring in 14 out of 6158 patients, none of which were serious 5
- There is a potential association between leukotriene-modifying agents, including montelukast, and suicidal behavior, although the evidence is based primarily on case reports 6
- A study of pediatric patients with asthma found that montelukast was associated with an excess incidence of neuropsychiatric outcomes, including sleep disorders, anxiety disorders, and mood disorders 7
Specific Psychiatric Side Effects
Some specific psychiatric side effects that have been associated with montelukast include:
- Sleep disorders: montelukast was associated with an increased risk of sleep disorders in pediatric patients with asthma 7
- Anxiety disorders: montelukast was associated with an increased risk of anxiety disorders in pediatric patients with asthma 7
- Mood disorders: montelukast was associated with an increased risk of mood disorders in pediatric patients with asthma 7
- Suicidal behavior: there is a potential association between montelukast and suicidal behavior, although the evidence is limited 6
Patient Populations
The risk of psychiatric side effects associated with montelukast may vary depending on the patient population. For example:
- Children: montelukast has been associated with an increased risk of neuropsychiatric outcomes, including sleep disorders, anxiety disorders, and mood disorders, in pediatric patients with asthma 7
- Adults: montelukast was well tolerated in adults, with adverse drug reactions occurring in 14 out of 6158 patients, none of which were serious 5