Asthma Management Handbook

Guide to preventers: montelukast


Preventers are used in maintenance treatment to reduce airway inflammation. They include leukotriene receptor antagonists (montelukast).

Table. Classification of asthma medicines Opens in a new window Please view and print this figure separately:

More information

Montelukast for adults: efficacy

In adults and adolescents with asthma that is not controlled by low-dose inhaled corticosteroid, the addition of a leukotriene receptor antagonist is less effective than the addition of a long-acting beta2 agonist in reducing the rate of asthma flare-ups that require treatment with oral corticosteroids.1 The addition of a leukotriene receptor antagonist is also associated with lesser improvement in lung function and quality of life than the addition of a long-acting beta2 agonist.1

Montelukast taken 1 hour before exercise can be used to manage exercise-induced bronchoconstriction, but it is less effective than short-acting beta2 agonists.2

Retrospective analysis of clinical trial data suggests that some people with asthma who smoke,3 or are obese,4 may achieve better asthma control with montelukast than an inhaled corticosteroid. However, prospective studies would be needed to confirm this.

Some individuals may also achieve better asthma control with montelukast than with an inhaled corticosteroid for reasons that are unknown and cannot be predicted from currently available data.

Although montelukast was previously thought to have particular benefits for people with aspirin-intolerant asthma, this has not been consistently demonstrated in clinical trials.

Within specialised severe asthma clinics, montelukast is sometimes prescribed as add-on treatment for adults.​

Note: PBS status as at October 2016: Montelukast treatment is not subsidised by the PBS for people aged 15 years or over. Special Authority is available for DVA gold card holders or white card holders with approval for asthma treatments.

Montelukast for adults and adolescents: psychiatric effects

Post-marketing surveillance reports led to concerns about a possible association between leukotriene receptor antagonist use and suicide risk.5 A recent case-control study reported a statistically significant association between the use of leukotriene receptor antagonists and suicide attempts in people aged 19–24 years. However, this association was no longer statistically significant after adjusting for potential confounding factors, including previous exposure to other asthma medicines and previous exposure to other medicines associated with suicide.5

Montelukast for children

Montelukast is registered by the TGA for use in children aged 2 years and older.6

Based on data from placebo-controlled trials, it has not been possible to define clinical indicators that predict which children will benefit most from montelukast therapy, compared with other treatment options.71

Comparative studies suggest that the main role for montelukast is as an alternative to low-dose inhaled corticosteroid in children with frequent intermittent asthma or mild persistent asthma.7

Children 0–5 years

In preschool children with multiple-trigger wheeze, montelukast protects against airway hyperresponsiveness when taken with or without inhaled corticosteroids.8 Inhaled corticosteroids are more effective than montelukast in children with multiple-trigger wheeze aged 2–8 years,9 but this comparison has not been made in preschool children as a separate group.8

In children aged 2–5 years with episodic (viral) wheeze, regular montelukast treatment reduces the risk of wheezing episodes.10 However, montelukast may not reduce symptoms in children aged 6–24 months with recurrent wheeze.11 

Note: Montelukast is not TGA-registered for use in children younger than 2 years.

A short course of montelukast, introduced at the first signs of an asthma episode or upper respiratory tract infection, can achieve a small reduction in symptoms, school absence and medical consultations in preschool and school-aged children with episodic wheeze.12 However, montelukast is not TGA-registered for intermittent use.

Children 6 years and over

In school-aged children with persistent asthma, inhaled corticosteroids are more effective than montelukast for a range of measures, including lung function.7

In school-aged children with persistent exercise-induced symptoms despite taking regular inhaled corticosteroids, montelukast is effective in controlling symptoms and is more effective than long-acting beta2 agonists.1314

In children who are already taking regular inhaled corticosteroids and have a beta2 receptor genotype associated with increased susceptibility to flare-ups during regular long-acting beta2 agonist therapy,15 montelukast may be more effective than salmeterol in reducing symptoms, reliever use and days absent from school due to asthma, based on the findings of a small randomised controlled clinical trial.15

Montelukast for children: warning parents about potential psychiatric adverse effects

Montelukast is generally very well tolerated.13 However, post-marketing surveillance reports suggested a slight increase in the rate of psychiatric disorders that was possibly associated with use of leukotriene receptor antagonists in children;16 this association may have been confounded by asthma severity and concomitant medication.13 Montelukast use has also been associated with suicidal ideation, but a recent nested case-control study concluded that children with asthma aged 5–18 years taking leukotriene receptor antagonists were not at increased risk of suicide attempts.5 Behavioural and psychiatric adverse effects were rare in clinical trials.17,18

A recent analysis of databases of adults and children taking montelukast suggests it is associated with nightmares, depression, and aggression.19 Allergic granulomatous angiitis has also been reported, but a causal relationship has not been established.19

The Thoracic Society of Australia and New Zealand advises that it is prudent to mention to parents the potential association of montelukast with behaviour-related adverse events when commencing treatment, and to cease therapy if such adverse events are suspected.13

Montelukast for exercise-induced bronchoconstriction

Montelukast is less effective against exercise-induced bronchoconstriction than short-acting beta2 agonists, but regular use is not associated with receptor tolerance.2

Montelukast taken either intermittently before exercise or daily is at least partially effective in protecting against exercise-induced bronchoconstriction in some, but not all patients.2 Some experience strong protection against exercise-induced bronchoconstriction while others experience only partial protection or no effect.2 Very few patients experience complete protection against exercise-induced bronchoconstriction.2

In children, regular montelukast, either as the child’s only preventer or in combination with an inhaled corticosteroid, is more effective than long-acting beta2 agonists in protecting against exercise-induced bronchoconstriction,14, 20 and is associated with a greater bronchodilator response to short-acting beta2 agonist after exercise.14

The onset of protection occurs within 2 hours of dosing. The duration of protective effect is 12–24 hours. Recommended doses are as follows:20

  • children aged 2–5 years 4 mg daily, or 1–2 hours before exercise
  • children aged 6–14 years 5 mg daily, or 1–2 hours before exercise
  • adults 10 mg daily, or 1–2 hours before exercise.


PBS status as at October 2016: Montelukast treatment is not subsidised by the PBS for:

  • people aged 15 years or over (Special Authority is available for DVA gold card holders, or white card holders with approval for asthma treatments.)
  • children aged 2 to 5 years in combination with any other preventer
  • children aged 6 to 14 years with moderate to severe asthma, when used use as a single second-line preventer as an alternative to corticosteroids
  • people of any age, when used in addition to a long-acting beta-agonist.
Oral montelukast in acute asthma

Evidence from randomised controlled clinical trials does not support routine use of oral leukotriene receptor agonists in acute asthma in adults or children.21

In children with acute asthma, the addition of oral montelukast to usual care does not reduce hospital admission rates, based on the findings of a systematic review and meta-analysis.21

In adults with acute asthma, the addition of oral montelukast to usual care may slightly reduce beta2 agonist requirement.21 The addition of oral zafirlukast was associated with improvement in lung function, compared with usual care.21



  1. Ducharme FM. Addition of anti-leukotriene agents to inhaled corticosteroids for chronic asthma. Cochrane Database Syst Rev. 2004; Issue 1: CD003133. Available from:
  2. Weiler JM, Anderson SD, Randolph C, et al. Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter. Ann Allergy Asthma Immunol. 2010; 105: S1-47. Available from:
  3. Lazarus SC, Chinchilli VM, Rollings NJ, et al. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. Am J Respir Crit Care Med. 2007; 175: 783-790. Available from:
  4. Peters-Golden M, Swern A, Bird SS, et al. Influence of body mass index on the response to asthma controller agents. Eur Respir J. 2006; 27: 495-503. Available from:
  5. Schumock GT, Stayner LT, Valuck RJ, et al. Risk of suicide attempt in asthmatic children and young adults prescribed leukotriene-modifying agents: a nested case-control study. J Allergy Clin Immunol. 2012; 130: 368-75. Available from:
  6. Merck, Sharp and Dohme Australia Pty Ltd. Product Information: Singulair (montelukast sodium) Tablets. Therapeutic Goods Administration, Canberra, 2013. Available from:
  7. National Asthma Council Australia. Leukotriene receptor antagonists in the management of childhood asthma. National Asthma Council Australia, Melbourne, 2010. Available from:
  8. Brand PL, Baraldi E, Bisgaard H, et al. Definition, assessment and treatment of wheezing disorders in preschool children: an evidence-based approach. Eur Respir J. 2008; 32: 1096-1110. Available from:
  9. Szefler SJ, Baker JW, Uryniak T, et al. Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma. J Allergy Clin Immunol. 2007; 120: 1043-50. Available from:
  10. Bisgaard H, Zielen S, Garcia-Garcia ML, et al. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005; 171: 315-322. Available from:
  11. Pelkonen AS, Malmström K, Sarna S, et al. The effect of montelukast on respiratory symptoms and lung function in wheezy infants. Eur Respir J. 2013; 41: 664-670. Available from:
  12. Robertson CF, Price D, Henry R, et al. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med. 2007; 175: 323-329. Available from:
  13. van Asperen PP, Mellis CM, Sly PD, Robertson C. The role of corticosteroids in the management of childhood asthma. The Thoracic Society of Australia and New Zealand, 2010. Available from:
  14. Fogel RB, Rosario N, Aristizabal G, et al. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010; 104: 511-517. Available from:
  15. Lipworth BJ, Basu K, Donald HP, et al. Tailored second-line therapy in asthmatic children with the Arg(16) genotype. Clin Sci (Lond). 2013; 124: 521-528. Available from:
  16. Wallerstedt SM, Brunlöf G, Sundström A, Eriksson AL. Montelukast and psychiatric disorders in children. Pharmacoepidemiol Drug Saf. 2009; 18: 858-864. Available from:
  17. Philip G, Hustad C, Noonan G, et al. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol. 2009; 124: 691-6.e6. Available from:
  18. Philip G, Hustad CM, Malice MP, et al. Analysis of behavior-related adverse experiences in clinical trials of montelukast. J Allergy Clin Immunol. 2009; 124: 699-706.e8. Available from:
  19. Haarman, MG, van Hunsel, F, de Vries, TW. Adverse drug reactions of montelukast in children and adults. Pharmacol Res Perspect. 2017; 5: e00341. Available from:
  20. Stelmach I, Grzelewski T, Majak P, et al. Effect of different antiasthmatic treatments on exercise-induced bronchoconstriction in children with asthma. J Allergy Clin Immunol. 2008; 121: 383-389. Available from:
  21. Watts K, Chavasse RJ. Leukotriene receptor antagonists in addition to usual care for acute asthma in adults and children. Cochrane Database Syst Rev. 2012; Issue 5: CD006100. Available from: