When is Montelukast (Singulair) given in asthma?

When Montelukast is Given in Asthma

Montelukast is used as an alternative (not preferred) controller medication for mild persistent asthma when patients cannot or will not use inhaled corticosteroids, or as add-on therapy in moderate-to-severe asthma inadequately controlled on inhaled corticosteroids alone. 1, 2

Primary Clinical Roles

As Alternative Monotherapy (Step 2 Care)

• Montelukast serves as an alternative to low-dose inhaled corticosteroids for mild persistent asthma, though inhaled corticosteroids remain the preferred first-line controller medication 1, 2
• The American College of Chest Physicians indicates montelukast can be considered when patients cannot or will not use inhaled corticosteroids 2
• This positioning applies to patients ≥2 years of age with persistent asthma requiring daily controller therapy 1, 3

Important caveat: The 2020 NAEPP guidelines note that the FDA issued a Boxed Warning for montelukast in March 2020 regarding neuropsychiatric adverse events, which should factor into prescribing decisions 1

As Add-On Therapy (Step 3-4 Care)

• For patients ≥12 years with inadequate control on inhaled corticosteroids alone, montelukast can be added as adjunctive therapy, though long-acting beta-agonists (LABAs) are the preferred add-on option 1, 2
• In children 6-14 years with moderate asthma uncontrolled on 400 mcg budesonide daily, adding montelukast showed modest improvements in peak flows and decreased beta-agonist use 1, 2
• The combination of montelukast plus inhaled corticosteroids provides better asthma control than inhaled corticosteroids alone in patients with poorly controlled asthma 4

Age-Specific Dosing

Children 2-5 Years

• Montelukast 4 mg chewable tablet once daily is approved for this age group 1, 3
• Clinical benefit is evident within 1 day of starting therapy 3
• Improvements occur in daytime symptoms, overnight symptoms, beta-agonist use, and peripheral blood eosinophils 3

Children 6-14 Years

• Montelukast 5 mg chewable tablet once daily is the recommended dose 1, 5
• This dose provides comparable systemic exposure to the adult 10-mg dose 5

Adolescents and Adults ≥15 Years

• Montelukast 10 mg film-coated tablet once daily is the standard dose 1, 6, 4
• Evening administration is recommended based on pharmacodynamic profile 2
• No additional clinical benefit occurs with doses above 10 mg daily 6

Specific Clinical Scenarios

Aspirin-Sensitive Asthma

• Montelukast provides effective control in aspirin-sensitive asthmatic patients 4, 7
• Improvements in asthma control are similar whether patients are aspirin-sensitive or not 7

Exercise-Induced Bronchoconstriction

• Montelukast attenuates the fall in pulmonary function following exercise in both adults and children 4, 7
• However, inhaled beta2-agonists remain first-line therapy for prophylaxis and treatment of exercise-induced symptoms 7

Corticosteroid-Sparing Strategy

• In adults with FEV1 ≥70% treated with montelukast for 12 weeks, inhaled corticosteroid dosages were reduced by 47% versus 30% in placebo recipients 4
• Montelukast allows tapering of inhaled corticosteroid doses while maintaining clinical stability, though this should be done cautiously 4, 7

Key Limitations and Positioning

Relative to Inhaled Corticosteroids

• Inhaled corticosteroids are significantly more effective than montelukast across most outcome measures in patients with persistent asthma 1
• When comparing overall efficacy, most outcomes clearly favor inhaled corticosteroids over leukotriene receptor antagonists 1

Relative to LABAs as Add-On Therapy

• Adding a LABA to inhaled corticosteroids is more effective than adding montelukast in patients ≥12 years 2
• The addition of LABAs to low-to-medium dose inhaled corticosteroids is the most effective treatment for moderate persistent asthma (Step 3 care) 1
• LABAs should never be used as monotherapy—they must be combined with inhaled corticosteroids 2

Clinical Monitoring

Onset and Duration of Effect

• Improvements in lung function and beta2-agonist usage are apparent within 1 day of initiating montelukast treatment 4, 3
• If clear benefit is not observed within 4-6 weeks with satisfactory technique and adherence, consider adjusting therapy or alternative diagnoses 1

Safety Monitoring

• No routine laboratory monitoring is required for montelukast, unlike theophylline which requires serum concentration monitoring 2
• Awareness of neuropsychiatric adverse events is necessary given the FDA Boxed Warning 1
• The frequency of adverse events in clinical trials was similar to placebo 4, 3

Long-Term Use

• No tachyphylaxis or change in safety profile has been evidenced after up to 140 weeks of montelukast therapy in adults and 80 weeks in children aged 6-14 years 3
• Tolerance does not develop with chronic use 7

Common Pitfalls to Avoid

• Never use montelukast for acute asthma relief—it is a controller medication only, not a rescue medication 2
• Do not substitute montelukast for inhaled corticosteroids as first-line therapy in patients who can use inhalers properly 1, 2
• Avoid using montelukast as the preferred add-on to inhaled corticosteroids when LABAs are suitable and available 2
• Do not discontinue inhaled corticosteroids abruptly when adding montelukast; any dose reduction should be gradual and monitored 1