Can montelukast (Singulair) be given to a 6-month-old infant?

Montelukast in 6-Month-Old Infants

Yes, montelukast can be given to a 6-month-old infant, as it has FDA approval and guideline support down to 6 months of age for asthma and allergic rhinitis, but only after careful consideration of the FDA black box warning regarding neuropsychiatric risks and discussion of safer alternatives with parents. 1, 2, 3

FDA-Approved Age and Dosing

• Montelukast is FDA-approved down to 6 months of age with an excellent safety profile according to guideline recommendations 1
• The appropriate dose for infants 6-23 months is 4 mg oral granules administered once daily 2, 3
• The medication has been evaluated for safety in 175 pediatric patients aged 6-23 months in controlled clinical trials 3

Critical Safety Considerations Before Prescribing

FDA Black Box Warning

• The FDA issued a black box warning regarding serious neuropsychiatric events including suicidal thoughts and actions, depression, anxiety, sleep disturbances, and behavioral changes 2
• Parents must be explicitly counseled about neuropsychiatric risks before prescribing, and safer alternatives (such as inhaled corticosteroids for asthma) should be considered first 2, 4
• Close monitoring for unusual behavioral or mood changes is required, particularly in the first weeks of therapy 2

Common Adverse Events in This Age Group

In infants 6-23 months, the following adverse events occurred with ≥2% frequency and more frequently than placebo 2, 3:

• Upper respiratory infection
• Wheezing
• Otitis media
• Pharyngitis and tonsillitis
• Cough
• Rhinitis

Clinical Context and Positioning

When to Consider Montelukast

• For infants with persistent asthma, inhaled corticosteroids remain the preferred first-line therapy 4
• Montelukast may be considered as an alternative therapy for mild persistent asthma when inhaled corticosteroids are not tolerated or compliance is an issue 4
• For patients with both asthma and allergic rhinitis (up to 40% of cases), montelukast may offer dual benefit since it is approved for both conditions 1

Practical Advantages

• Once-daily oral administration offers superior compliance compared to inhaled therapies in young children 5, 6
• Available as oral granules, which can be administered directly in the mouth or mixed with soft food 2
• Clinical improvements in lung function and symptom reduction typically observed within 1 day of initiating therapy 5, 6

Important Clinical Pitfalls

Recent Safety Data

• A 2022 study reported neuropsychiatric adverse reactions are more prevalent than previously documented, with 31.9% of children experiencing adverse drug reactions 7
• Sleep disturbances affected 15.1% of children, followed by agitation (10.4%), pain (9.4%), and hyperactivity (6.8%) 7
• These rates are notably higher than placebo-controlled trials suggested, emphasizing the importance of careful monitoring 7

Counseling Requirements

Before prescribing, ensure parents understand:

• The medication is not a bronchodilator or rescue medication 7
• It is not a steroid (common misconception in 9.8% of families) 7
• It is a preventive controller medication requiring daily use 7
• The specific neuropsychiatric warning signs to watch for 2

Long-Term Safety Profile

• Montelukast has been studied for extended periods with no significant change in adverse event profile with prolonged use 3, 8
• The clinical and laboratory safety profile in infants was similar to placebo in controlled trials 3, 8
• No serious adverse drug reactions or cardiotoxicities have been reported in pediatric populations 8, 9