Singulair (Montelukast Sodium) - Summary

SINGULAIR SUMMARY

What is SINGULAIR¹?

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.

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

See all Singulair indications & dosage >>

SINGULAIR NEWS HIGHLIGHTS

Media Articles Related to Singulair (Montelukast)

Merck Statement In Response To The FDA's June 12, 2009 Communication With Updated Information On Leukotriene Inhibitors, Including SINGULAIR(R)
Source: Allergy News From Medical News Today [2009.06.15]
Merck & Co., Inc. issued the following statement in response to today's communication from the U.S. Food & Drug Administration (FDA) addressing updated information on leukotriene inhibitors, including SINGULAIR® (montelukast sodium).

FDA Checks Into Singulair Suicide Risk
Source: MedicineNet montelukast Specialty [2008.03.28]
Title: FDA Checks Into Singulair Suicide Risk
Category: Health News
Created: 3/28/2008
Last Editorial Review: 3/28/2008

Knocking The Wind Out Of Asthmatics: Help From Hippocrates
Source: Allergy News From Medical News Today [2009.06.23]
Last week the FDA knocked the wind out of asthmatics by requesting the manufacturers of Singulair, a popular leukotriene blocking asthma and allergy drug, to upgrade their warning against psychotic side effects. Further respiratory distress was imposed on Zicam users when the FDA also last week announced warnings that the drug may cause a loss of smell.

FDA Requests Labeling Change For Leukotriene Modifiers
Source: Allergy News From Medical News Today [2009.06.15]
The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

FDA flags psychiatric risks of asthma drugs (AP)
Source: Y! Health Asthma News [2009.06.12]
AP - New labels on popular asthma drugs like Merck's Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, federal regulators said Friday.

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Published Studies Related to Singulair (Montelukast)

A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. [2008.12]
BACKGROUND: Cysteinyl leukotrienes are implicated in the inflammation of bronchiolitis. Recently, a specific cysteinyl leukotriene receptor antagonist, montelukast (Singulair [MSD, Haarlem, Netherlands]), has been approved for infants in granule sachets. OBJECTIVE: Our goal was to evaluate the effect of montelukast on clinical progress and on cytokines in acute bronchiolitis... CONCLUSIONS: Montelukast did not improve the clinical course in acute bronchiolitis. No significant effect of montelukast on the T-helper 2/T-helper 1 cytokine ratio when given in the early acute phase could be demonstrated.

Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study. [2008.12]
BACKGROUND: Clinical trials in children with moderate-to-severe persistent asthma are limited. OBJECTIVE: We sought to determine whether azithromycin or montelukast [generic for Singulair] are inhaled corticosteroid sparing... CONCLUSION: Based on these results, neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma.

Montelukast as an adjunct to oral and inhaled steroid therapy in chronic nasal polyposis. [2008.11]
OBJECTIVE: To examine the potential of montelukast [generic for Singulair], a leukotriene receptor antagonist, as an adjunct to oral and inhaled steroid in subjects with chronic nasal polyps... CONCLUSION: Montelukast therapy may have clinical benefit as an adjunct to oral and inhaled steroid in chronic nasal polyposis, but effects are not maintained after cessation of treatment.

Study of montelukast for the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children. [2008.10.15]
RATIONALE: A pilot study (Bisgaard H; Study Group on Montelukast [generic for Singulair] and Respiratory Syncytial Virus. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. Am J Respir Crit Care Med 2003;167:379-383) reported the efficacy of montelukast in post-respiratory syncytial virus (RSV) bronchiolitic respiratory symptoms. OBJECTIVES: To evaluate the efficacy and safety of montelukast, 4 and 8 mg, in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large, multicenter study... CONCLUSIONS: In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.

Fluticasone or montelukast for preschool children with asthma-like symptoms: Randomized controlled trial. [2008.10]
RATIONALE: Beneficial effects of anti-inflammatory therapy such as fluticasone propionate (FP) and montelukast [generic for Singulair] (Mk) have been demonstrated in preschool children with asthma. However, comparative studies are lacking in this age group. Therefore, we conducted a study to evaluate and compare the effect of FP and Mk in preschool children with asthma-like symptoms... CONCLUSIONS: In spite of a lack of power, our results suggest that FP has a beneficial effect on symptoms and Mk on blood eosinophil level as compared to placebo. Except for a difference in one lung function parameter after 3 months between FP and Mk in favor of the FP group, this study revealed no differences between FP and Mk.

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Clinical Trials Related to Singulair (Montelukast)

Exercise Induced Bronchospasm in Children [Completed]
The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease [Completed]
This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow measurements, and health care utilization were also assessed as secondary outcomes. Participants were recruited from the Kaiser Permanente Northwest member population. One hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or placebo, and were followed for a six-week period. No differences in lung function measures, health-related quality of life, health care utilization, and asthma symptom scores were observed; however, the montelukast group had slightly improved asthma control scores compared to the placebo group.

A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years [Completed]

Montelukast in Acute RSV Bronchiolitis [Completed]
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased

cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast

(Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.

First Step With Singulair® Therapy [Completed]
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

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SINGULAIR PATIENT REVIEWS / RATINGS / COMMENTS

Singulair review by care giver of 4 year old male patient
		Rating
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
		Rating
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 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Asthma, Allergies
Dosage & duration:		10 mg per day taken once a day for the period of 6 years
Other conditions:		severe asthma, environmental allergies, depression
Other drugs taken:		inhaled cortisteroids, antihistamines, ssri
		Reported Results
Benefits:		some reduction in lung inflammation
Side effects:		Severe mood swings, depression, frequent lung infections
Comments:		I took singulair for years before I realized that it was not really doing much and I strongly suspect that it contributed to my severe depression and mood swings. I have always had severe asthma and allergies and was hospitalized many times as a youngster. I did have allergy shots which I truly think helped with my allergies. When I got older, and inhaled cortisteroids were invented I started taking them, along with Singulair. I was told that it was the "most benign medication that I was on" so I never thought twice about popping that small pill each day. I suffered from frequent chest infections - that is a side effect of the singulair since it blocks the leuketrines that react and cause inflammation. When I was 25, I started having severe mood swings and had to start taking an anti-depressant. I continued the singulair without any thoughts. However, after my third child, we were broke and I was trying to cut some medications down to save money and I stopped the singulair for a while. I did notice that my asthma got worse so I figured oh well, have to start the Singulair again, that's when I started having the severe mood swings again. I started doing some research online and read an article written by a mother who lost her son to suicide and attributed it to the singulair. In my heart of hearts, I truly believe that more attention should be given to this drug, and it's affects on the brain. I am no longer taking it and I am having much better luck with zyrtec.