For what conditions and ages can Montelukast (Singulair) be prescribed in children?

Montelukast Prescribing in Children: Age-Specific Indications

Montelukast may be prescribed for all three pediatric scenarios listed: a child with exercise-induced asthma (≥6 years), a child with moderate persistent asthma (as adjunctive therapy), and an infant as young as 6 months with perennial allergic rhinitis—though the seasonal allergic rhinitis indication requires the child to be at least 2 years old. 1, 2

FDA-Approved Age Ranges by Indication

Asthma Indications

• 6 months and older: FDA-approved for asthma treatment (4-mg oral granules for infants 6-23 months) 1, 2
• 2-5 years: 4-mg chewable tablet once daily 1, 2
• 6-14 years: 5-mg chewable tablet once daily 1, 2
• ≥15 years: 10-mg tablet once daily 2

Allergic Rhinitis Indications

• Perennial allergic rhinitis: FDA-approved from 6 months of age 1, 2
• Seasonal allergic rhinitis: FDA-approved from 2 years of age 1, 2

Exercise-Induced Bronchoconstriction

• ≥6 years: Clinical evidence supports use for exercise-induced asthma 1
• ≥15 years: FDA-approved specifically for prevention of exercise-induced bronchoconstriction 3

Clinical Positioning by Asthma Severity

Mild Persistent Asthma

• Montelukast is recommended as an alternative therapy when inhaled corticosteroids cannot be used or compliance is problematic 1, 4
• Inhaled corticosteroids remain superior to montelukast for asthma control (NNT approximately 6.5) 1
• Montelukast offers once-daily oral administration with superior compliance compared to inhaled therapies 1

Moderate Persistent Asthma

• Montelukast should NOT be used as monotherapy for moderate-to-severe persistent asthma 1, 4
• Can be combined with inhaled corticosteroids as an alternative to long-acting beta-agonists, though less preferred 1
• In patients ≥12 years, long-acting beta-agonists are preferred over montelukast as add-on therapy 1

Exercise-Induced Asthma

• Montelukast is effective for exercise-induced asthma in children as young as 6 years 1
• Never use montelukast for acute asthma exacerbations or rescue therapy—always ensure a short-acting beta-agonist is available 4

Critical Safety Considerations: FDA Black Box Warning

Before prescribing montelukast to any child, parents must be explicitly counseled about serious neuropsychiatric risks 1, 4:

Neuropsychiatric Events to Discuss

• Suicidal thoughts and actions 1, 4
• Depression and anxiety 1, 4
• Sleep disturbances 1, 4
• Behavioral changes 1, 4

Monitoring Requirements

• Monitor for unusual behavioral or mood changes, particularly in the first weeks of therapy 1, 4
• Safer alternatives (inhaled corticosteroids) should be considered first 1

Common Pitfalls to Avoid

Inappropriate Use Scenarios

• Do not use for acute exacerbations: Montelukast provides continuous control only and requires daily administration 4
• Do not discontinue when symptoms improve: Must be taken continuously daily to maintain efficacy 4
• Onset of action occurs by the second day, unlike antihistamines which work quickly 1, 4

Comparative Efficacy Considerations

• For allergic rhinitis, intranasal corticosteroids are more effective than montelukast and should be first-line 4
• Montelukast has similar efficacy to oral antihistamines but is less effective than intranasal corticosteroids 4
• Optimal use: patients with both asthma and allergic rhinitis benefit from dual indication coverage 1, 4

Specific Answer to Question Options

• Exercise-induced asthma (age-appropriate child ≥6 years): YES, approved and effective 1
• Moderate persistent asthma (age-appropriate child): YES, but only as adjunctive therapy with inhaled corticosteroids, NOT as monotherapy 1, 4
• Seasonal allergic rhinitis in infant (specific age matters): YES if ≥2 years; NO if younger than 2 years (though perennial allergic rhinitis is approved from 6 months) 1, 2