What are the recommended dosing, indications, and safety precautions for montelukast (Singulair) in children (≥2 years) and adults with persistent asthma or allergic rhinitis?

Montelukast (Singulair) Recommendations

Montelukast is FDA-approved for asthma (≥12 months), seasonal allergic rhinitis (≥2 years), and perennial allergic rhinitis (≥6 months), but should be reserved as second-line therapy after intranasal corticosteroids for rhinitis, and after inhaled corticosteroids for asthma, with mandatory counseling about FDA black box warnings for neuropsychiatric events before prescribing to any patient. 1, 2

Critical Safety Warning

Before prescribing montelukast to any patient, especially children, you must explicitly counsel about the FDA black box warning regarding serious neuropsychiatric events, including suicidal thoughts and actions, depression, anxiety, sleep disturbances, and behavioral changes. 2, 1, 3

• Monitor for unusual behavioral or mood changes, particularly in the first weeks of therapy 2
• Stop treatment immediately if any neuropsychiatric side effects occur 3
• Discuss safer alternatives (intranasal corticosteroids for rhinitis, inhaled corticosteroids for asthma) before initiating montelukast 4, 2

FDA-Approved Indications and Age-Specific Dosing

Asthma (Long-term Management)

• Adults and adolescents ≥15 years: 10 mg tablet once daily in the evening 1
• Children 6-14 years: 5 mg chewable tablet once daily in the evening 1, 2
• Children 2-5 years: 4 mg chewable tablet or oral granules once daily in the evening 1, 2
• Infants 12-23 months: 4 mg oral granules once daily in the evening 1, 2

Exercise-Induced Asthma Prevention

• Patients ≥15 years: 10 mg tablet at least 2 hours before exercise, but not more than once daily 1
• Do not take an additional dose within 24 hours of a previous dose 1
• If already taking montelukast daily for chronic asthma or allergic rhinitis, do not take an additional dose for exercise 1

Seasonal Allergic Rhinitis

• Adults and adolescents ≥15 years: 10 mg tablet once daily 1
• Children 6-14 years: 5 mg chewable tablet once daily 1
• Children 2-5 years: 4 mg chewable tablet or oral granules once daily 1

Perennial Allergic Rhinitis

• Adults and adolescents ≥15 years: 10 mg tablet once daily 1
• Children 6-14 years: 5 mg chewable tablet once daily 1
• Children 6 months-5 years: 4 mg oral granules once daily 1, 2

Clinical Positioning: When to Use Montelukast

For Allergic Rhinitis

Intranasal corticosteroids are superior to montelukast and should be recommended as first-line therapy for both seasonal and persistent allergic rhinitis. 5, 6, 4

• The ARIA guidelines strongly recommend intranasal corticosteroids over oral leukotriene receptor antagonists for seasonal allergic rhinitis 5
• Montelukast is less effective than intranasal corticosteroids for symptom control 6, 4
• Oral H1-antihistamines are also preferred over montelukast for seasonal allergic rhinitis 5

Consider montelukast for allergic rhinitis in these specific scenarios:

• Patients who refuse or cannot tolerate intranasal corticosteroids 4
• Patients with concurrent asthma and allergic rhinitis, as montelukast addresses both conditions simultaneously 6, 7, 8
• As add-on therapy when intranasal corticosteroids alone provide inadequate control 4
• Preschool children with persistent allergic rhinitis (conditional recommendation) 5

For Asthma

Inhaled corticosteroids are superior to montelukast for asthma control and should be first-line therapy for persistent asthma. 2

• Inhaled corticosteroids have a number needed to treat (NNT) of approximately 6.5 compared to montelukast for asthma control in children with mild-to-moderate persistent asthma 2
• Montelukast should not be used as monotherapy for moderate-to-severe persistent asthma 2
• When used as add-on therapy to inhaled corticosteroids, long-acting beta-agonists are more effective than montelukast 2

Consider montelukast for asthma in these specific scenarios:

• Alternative therapy for mild persistent asthma when inhaled corticosteroids are not tolerated or compliance is problematic 2
• Patients with both asthma and allergic rhinitis, offering dual benefit 2, 7, 8
• Adjunctive therapy with inhaled corticosteroids for moderate persistent asthma (though less preferred than long-acting beta-agonists in patients ≥12 years) 2
• Children with compliance issues or steroid-phobic parents 2

Administration Guidelines

Timing and Food

• Evening administration is recommended for asthma based on pharmacodynamic profile 6
• For allergic rhinitis, take once daily at about the same time each day 1
• May be taken with or without food 1

Oral Granules Administration (for infants and young children)

• Do not open packet until ready to use 1
• Can be given directly in the mouth, dissolved in 1 teaspoon (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft foods (applesauce, mashed carrots, rice, or ice cream) at cold or room temperature 1
• Must be given within 15 minutes of mixing; never store mixed granules for later use 1
• Do not put in any liquid drink other than baby formula or breast milk 1

Onset of Action

• Clinical benefits begin by the second day of daily treatment, which is slower than antihistamines 6, 4
• Provides continuous control rather than acute symptom relief 6
• Must be taken continuously daily to maintain efficacy 2

Critical Prescribing Precautions

What Montelukast Is NOT For

• Do not use for immediate relief of asthma attacks 1
• Do not use for acute asthma exacerbations or rescue therapy 2
• Always ensure patients have a short-acting beta-agonist available for acute symptoms 2, 1
• Do not stop or lower the dose of other asthma medicines unless instructed by physician 1

When to Contact Physician

• If asthma symptoms worsen or need for rescue inhaler increases 1
• If any neuropsychiatric symptoms develop (agitation, aggressive behavior, depression, anxiety, suicidal thoughts, sleep disturbances, hallucinations) 1, 3

Common Adverse Events

In Infants (6-23 months)

• Upper respiratory infection, wheezing, otitis media, pharyngitis, tonsillitis, cough, and rhinitis (≥2% frequency, more than placebo) 2

General Population

• Increased bleeding tendency, allergic reactions (including facial/throat swelling, hives), drowsiness, numbness, seizures, palpitations, nosebleed, diarrhea, indigestion, nausea, vomiting, hepatitis, bruising, joint pain, muscle aches, and swelling 1
• Behavior and mood-related changes: agitation, aggressive behavior, bad dreams, depression, anxiety, hallucinations, irritability, restlessness, sleepwalking, suicidal thoughts and actions, tremor, trouble sleeping 1

Special Populations

Pregnancy and Breastfeeding

• Discuss risks and benefits; montelukast may not be appropriate during pregnancy 1
• Montelukast may be passed in breast milk; consult physician before breastfeeding 1

Aspirin-Sensitive Asthma

• Continue to avoid aspirin and NSAIDs while taking montelukast 1

Clinical Evidence Supporting Dual Benefit

In patients with both asthma and allergic rhinitis, montelukast provides significant relief from rhinitis symptoms while conferring asthma benefit, reducing both rhinitis symptoms and as-needed beta-agonist use 7, 8. Real-world evidence shows 86.5% of patients report strong or marked improvement in daytime asthma symptoms and over 77% report improvement in all allergic rhinitis symptoms after 4-6 weeks of treatment 8.