Montelukast sodium

(Singulair®)

Montelukast sodium

Drug updated on 9/4/2024

Dosage FormFilm-coated tablet (oral: 10 mg); Chewable tablet (oral: 4 mg, 5 mg); Granule (oral, 4 mg)
Drug ClassLeukotriene receptor antagonist
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
  • Indicated for acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
  • Indicated for relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older.

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Summary
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  • Singulair (montelukast sodium) is indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older; acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older; and relief of symptoms of allergic rhinitis (AR), including seasonal allergic rhinitis (SAR) in patients 2 years of age and older and perennial allergic rhinitis (PAR) in patients 6 months of age and older.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • In adults with cough variant asthma (CVA), montelukast combined with inhaled corticosteroids (ICS) and long-acting β2 agonists (LABAs) improved the total effective rate (RR = 1.20, 95% CI [1.13, 1.27], P < 0.01) and reduced the recurrence rate (RR = 0.28, 95% CI [0.15, 0.53], P < 0.01).
  • In children with asthma or allergic rhinitis, montelukast was effective in controlling asthma symptoms (SMD = 0.90, 95% CI [0.44-1.36]), though inhaled corticosteroids were superior for controlling daytime (SMD = -0.12) and night-time symptoms (SMD = -0.23).
  • The combination of loratadine and montelukast in allergic rhinitis was superior in reducing total nasal symptom scores (TNSS) compared to loratadine (SMD = -1.00), montelukast (SMD = -0.46), and placebo (SMD = -0.93).
  • In adults with cough variant asthma (CVA), montelukast as an adjuvant therapy showed a higher incidence of adverse reactions compared to the control group, but this was not statistically significant (RR = 1.32, 95% CI [0.89, 1.96], P = 0.17).
  • In pediatric patients with obstructive sleep apnea (OSA), reported adverse reactions to montelukast included headache, nausea, and vomiting.
  • The reviewed evidence includes subgroup considerations for adults with CVA (montelukast combined with ICS and LABAs), children and adolescents with asthma/allergic rhinitis (montelukast vs. placebo and inhaled corticosteroids), children with CVA (montelukast with fluticasone), pediatric patients with mild to moderate OSA (efficacy and safety of montelukast), children aged 4 to 18 years with asthma (montelukast vs. SFC), children 5 years or younger with asthma/VIW (nebulized corticosteroids vs. montelukast), and adults and children with allergic rhinitis (montelukast vs. oral antihistamines and intranasal corticosteroids).

Product Monograph / Prescribing Information

Document TitleYearSource
Singulair (montelukast sodium) Prescribing Informaiton.2012Merck & Co., Inc., Whitehouse Station, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines