Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 8/8/2025

Asthma Management in Children

Introduction to Montelukast

  • The FDA-approved dosage of Singular (montelukast) for children aged 6-14 years is 5 mg chewable tablet once daily, which is the recommended dose for this age group 1
  • Montelukast dosing is age-specific, with recommended doses of 5 mg chewable tablet once daily for ages 6-14 years, 10 mg tablet once daily for ages 15+ years, 4 mg chewable tablet or oral granules once daily for ages 2-5 years, and 4 mg oral granules once daily for ages 6-23 months 1

Dosage and Administration

  • The 5 mg chewable tablet dose for children 6-14 years was selected to provide comparable drug exposure to the 10 mg adult dose, as determined through pharmacokinetic studies 1
  • Montelukast should be taken once daily in the evening, and can be taken with or without food 1
  • For children who cannot swallow tablets, the chewable formulation is preferred 1

Safety and Efficacy

  • Montelukast has demonstrated efficacy in reducing daytime asthma symptoms, decreasing "as-needed" beta-agonist use, reducing nocturnal awakenings, and improving airway function measures (FEV1, peak flow) 1
  • Montelukast can provide near-maximal effect within the first day of treatment, although the exact timing may vary 1
  • Common side effects of montelukast include headache, which occurs at a rate similar to placebo, and monitoring for changes in behavior, mood, or sleep patterns is important 1

Role in Therapy

  • Montelukast is considered an alternative, but not preferred, therapy for step 2 care (mild persistent asthma) and can be used as adjunctive therapy with inhaled corticosteroids, according to the American Academy of Allergy, Asthma, and Immunology 1
  • Correct dosing is critical, and using the adult dose (10 mg) instead of the recommended pediatric dose (5 mg) for an 8-year-old may lead to unnecessary medication exposure without additional clinical benefit 1