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Singulair (Montelukast Sodium) - Summary



Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.


SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

Exercise-Induced Bronchoconstriction

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.

Allergic Rhinitis

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

See all Singulair indications & dosage >>


Published Studies Related to Singulair (Montelukast)

Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. [2013]
in children... CONCLUSION: This study demonstrated that treatment with montelukast in

A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation. [2013]
accelerate lung function recovery when given in an acute exacerbation... CONCLUSION: Our study suggests that there is no benefit of addition of oral

[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. [2011.07]
OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children... CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The effect of montelukast on bronchial hyperreactivity and lung function in asthmatic children aged 6-13 years. [2011.06]
BACKGROUND: Cysteinyl leukotrienes have been shown to play an important role in the pathogenesis of asthma. The effect of the leukotriene receptor antagonist, montelukast, on bronchial hyperreactivity (BHR) as measured by the methacholine challenge test in school childre in has not been reported. OBJECTIVE: To determine the effect of montelukast (Singulair) on BHR measured by methacholine challenge and lung function tests in Thai asthmatic children aged 6-13 years... CONCLUSION: Montelukast significantly improved FEV1 and FEV1/FVC but not BHR in mild to moderate persistent asthmatic children aged 6-13 years after the 6 weeks of treatment.

Intermittent or daily montelukast versus placebo for episodic asthma in children. [2011.06]
BACKGROUND: No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype. OBJECTIVE: To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma... CONCLUSIONS: Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints. Copyright (c) 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Singulair (Montelukast)

The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity [Completed]
The purpose is to determine whether montelukast during 6 weeks has superior antitussive effects (measured with the LCQ) compared with placebo in patients with cough lasting > 8 weeks and enhanced bronchial hyperreactivity.

The Effect of Montelukast Treatment in Wheezy Infants [Completed]
The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.

Genotype Stratified Pharmacokinetic Study of Montelukast [Recruiting]
Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms associated with asthma. Singulair (montelukast), manufactured by Merck, is a popular LTRA, however its effectiveness varies greatly between individuals. We are interested in understanding why the effectiveness of Singulair varies so greatly. For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We have found that blood levels of Singulair vary greatly between individuals, and we think that this variability is responsible for variability in response. Drug absorption occurs primarily in the intestine. Due to differences in the chemical properties of drugs, some drugs can be absorbed easily while other drugs require help from special proteins produced by the cells that line the intestine. These proteins, or transporters act like revolving doors to allow drugs to move from the intestine to the bloodstream. The activity of a transporter can be influenced by individual genetic variability. We think that adsorption of Singulair requires help from a transport protein called OATP2B1. We have found that a single common genetic change in this protein is associated with low plasma concentration of montelukast. In this proposal we will determine plasma levels of montelukast in individuals with two copies of this genetic change. We predict that these individuals will have roughly half the plasma level of montelukast as individuals with no copies of this genetic change. Eventually, what we learn from this work will allow doctors to quickly test individuals with asthma to determine how well they will absorb Singulair and possibly other LTRAs. Knowing this will allow the doctor to adjust the drug treatment on an individual basis to maximize benefit in the treatment of asthma.

The Effectiveness of Montelukast on Atopic Dermatitis in Koreans [Completed]
The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).

Montelukast in Very Low Birthweight Infants [Completed]
The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD).

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Reports of Suspected Singulair (Montelukast) Side Effects

Aggression (70)Suicidal Ideation (68)Depression (57)Abnormal Behaviour (54)Allergic Granulomatous Angiitis (50)Anxiety (41)Agitation (39)Insomnia (36)Irritability (34)Nightmare (32)more >>


Based on a total of 21 ratings/reviews, Singulair has an overall score of 6.14. The effectiveness score is 7.33 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Singulair review by care giver of 4 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Hay fever type allergy reactions
Dosage & duration:   1 tablet disolved in mouth at night taken daily for the period of 4 months
Other conditions:   dry skin- childhood excema
Other drugs taken:   none
Reported Results
Benefits:   My son attends a preschool with many mulberry trees on the grounds. These trees drop large amounts of pollen right on the children during parts of the year. He would begin to itch all over and develop red splotches on his face. The pediatrician prescribed Singular each night and it has alleviated all his symptoms.
Side effects:   We have not seen any side effects. He is not even made sleepy by this antihisitamine.
Comments:   One tablet disolved in mouth before bed. He dislikes the taste, but we solve that by taking his gummy vitamins immediately after the Singular.


Singulair review by 45 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   asthma
Dosage & duration:   10mg taken daily for the period of several years
Other conditions:   Restless leg syndrome
Other drugs taken:   requip
Reported Results
Benefits:   I find that this drug effectively eliminates symptoms of restless leg syndrome. When having to sit in one position for extended periods (long air flights, car trips, meetings,) I experience great discomfort and an almost uncontrollable need to move my legs. This drug eliminates all discomfort and compulsion to move. It's terrific!
Side effects:   none
Comments:   I take one pill as needed.


Singulair review by care giver of 11 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   asthma
Dosage & duration:   5 mg taken daily for the period of 24 days
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   none
Side effects:   Severe neuropsychiatric side effects, including suicide ideation, nightmares, hallucinations, horrible headaches, anger/hostility, reckless/abnormal behavior, dilated pupils, fatigue, pain in joints.
Comments:   This drug is poison and should not be given to children. My daughter was prescribed this for mild asthma. Doctors don't know or don't care about the dangerous, life-threatening side effects of this drug. This is Merck's biggest money maker. There are much more effective, less dangerous treatments for asthma. Spread the word. Get active.

See all Singulair reviews / ratings >>

Page last updated: 2014-12-01

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