Singulair

Asthma, Hay Fever, Asthma, Exercise-Induced + 2 more
Treatment
9 FDA approvals
20 Active Studies for Singulair

What is Singulair

MontelukastThe Generic name of this drug
Treatment SummaryMontelukast was approved by the FDA in 1998 and is a type of drug used to treat asthma. It is typically prescribed in addition to, or along with, inhaled corticosteroids. In 2008-2009, investigations were conducted into the possibility of montelukast causing neuropsychiatric effects such as agitation, hallucinations, and suicidal behavior. Although these effects are listed in the official prescribing information for montelukast, the drug is still widely used and millions of prescriptions are issued each year. It is now available as a generic and brand name product.
Singulairis the brand name
image of different drug pills on a surface
Singulair Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Singulair
Montelukast
1998
281

Approved as Treatment by the FDA

Montelukast, otherwise called Singulair, is approved by the FDA for 9 uses such as Rhinitis, Allergic and Hay Fever .
Rhinitis, Allergic
Helps manage Perennial Allergic Rhinitis (PAR)
Hay Fever
Helps manage Seasonal Allergic Rhinitis
Asthma
Exercise-Induced Bronchospasm
Seasonal Allergic Rhinitis
Helps manage Seasonal Allergic Rhinitis
Asthma
Perennial Allergic Rhinitis (PAR)
Helps manage Perennial Allergic Rhinitis (PAR)
Disease
Helps manage inadequate response to conventional therapy
Asthma, Exercise-Induced

Effectiveness

How Singulair Affects PatientsMontelukast is a drug that blocks the leukotriene receptor in the airways, reducing inflammation and narrowing of the airways to help with asthma and allergies. It takes effect within two hours of being taken, and can be taken with a beta agonist drug for added benefit. Clinical studies have shown that taking doses higher than 10mg per day do not provide any additional benefit. Montelukast has been shown to reduce eosinophils (a type of white blood cell) by 13-15% in people with asthma, and by 13% in those with seasonal allergies.
How Singulair works in the bodyCysteinyl leukotrienes are molecules released by cells like mast cells and eosinophils. When these molecules bind to specific receptors, they can cause symptoms of asthma and allergic rhinitis like bronchoconstriction, mucus production, and inflammation. Montelukast is a drug that binds to these receptors, blocking the molecules from causing these symptoms. This helps relieve asthma and allergic rhinitis.

When to interrupt dosage

The advised measure of Singulair is contingent upon the diagnosed condition, like Exercise-Induced Bronchospasm, inadequate response to conventional therapy and Hay Fever. The dose of dosage is subject to the administration form (e.g. Tablet, chewable or Granule - Oral) featured in the table below.
Condition
Dosage
Administration
Asthma, Exercise-Induced
10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral
Asthma
10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral
Hay Fever
10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral
Disease
10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral
Rhinitis, Allergic
10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Warnings

There are 20 known major drug interactions with Singulair.
Common Singulair Drug Interactions
Drug Name
Risk Level
Description
Brigatinib
Major
The metabolism of Brigatinib can be decreased when combined with Montelukast.
Cabazitaxel
Major
The metabolism of Cabazitaxel can be decreased when combined with Montelukast.
Cyclophosphamide
Major
The metabolism of Cyclophosphamide can be decreased when combined with Montelukast.
Enasidenib
Major
The metabolism of Enasidenib can be decreased when combined with Montelukast.
Erlotinib
Major
The metabolism of Erlotinib can be decreased when combined with Montelukast.
Singulair Toxicity & Overdose RiskOverdosing on montelukast may cause abdominal pain, drowsiness, excessive thirst, headaches, vomiting, or hyperactivity. Tests have shown the lowest toxic dose in mice and rats is greater than 5000mg/kg. Montelukast should not be used during pregnancy or while breastfeeding, and elderly patients may have a longer half-life of the drug in their system.

Singulair Novel Uses: Which Conditions Have a Clinical Trial Featuring Singulair?

148 ongoing trials are investigating the potential of Singulair to provide an adequate response to conventional therapy, Asthma and Perennial Allergic Rhinitis (PAR) treatment.
Condition
Clinical Trials
Trial Phases
Asthma
92 Actively Recruiting
Phase 1, Phase 4, Early Phase 1, Phase 2, Not Applicable, Phase 3
Disease
0 Actively Recruiting
Asthma, Exercise-Induced
0 Actively Recruiting
Hay Fever
0 Actively Recruiting
Rhinitis, Allergic
0 Actively Recruiting

Singulair Reviews: What are patients saying about Singulair?

5Patient Review
2/22/2020
Singulair for Allergic Asthma
I've tried everything on the market for my condition, and this is by far the best option. I don't have any issues with depression, but there has been some occasional dizziness.
5Patient Review
6/1/2022
Singulair for Allergic Asthma
This pill has been a game-changer for me. I no longer have to rely on allergy medication, steroids, or shots.
4.7Patient Review
5/29/2020
Singulair for Allergic Asthma
Zyrtec didn't do much for me in terms of my seasonal allergies, but Singulair really worked wonders. I noticed a difference within a few days of taking it, and now I don't need to use my rescue inhaler at all.
4Patient Review
11/15/2020
Singulair for Exercise-Induced Bronchospasm Prevention
While it hasn't been perfect, this drug has helped me. I haven't experienced any of the negative side effects that I've read about in other reviews. (I actually wonder if they are using this drug as a scapegoat for their issues). After years of taking this, a mix up with the pharmacy and needing a call to Dr for refill, I ended up not taking it for a couple weeks. I had lousy allergy/sinus crud that makes people look weird at you during this Covid19 snafu.
4Patient Review
6/22/2022
Singulair for Allergic Asthma
I began using Singulair yesterday and saw a significant difference in how clear my lungs felt. I was initially worried it was temporary, but after 24 hours I'm still feeling the same relief. This is really encouraging and has me excited for the future.
3.7Patient Review
5/11/2022
Singulair for Controller Medication for Asthma
Singulair is effective for my allergies-induced asthma; however, it gives me terrible tooth pain. I've been to the dentist multiple times and they can't explain it. When I stopped taking Singulair, the pain went away after a few days; but as soon as I started again, the pain came back. So unfortunately, I have to say that I cannot take this medication.
3.3Patient Review
4/27/2021
Singulair for Allergic Asthma
I had some serious mood swings while taking this, to the point where I had to stop and start a few times. If you're susceptible to that sort of thing, be warned.
3Patient Review
11/26/2021
Singulair for Controller Medication for Asthma
I've been taking this medication for over a year now, and I honestly can't tell if it's doing anything.
2.7Patient Review
2/7/2020
Singulair for Allergic Asthma
This provided excellent relief of my allergies and asthma, but the level of depression I experienced was really concerning. I felt like everything in my life was pointless, which is a shame because this otherwise would have been a great medication for me.
2.3Patient Review
9/20/2022
Singulair for Controller Medication for Asthma
Singular worked for me while I was taking it, but I experienced some very intense and vivid nightmares. My physician just brushed it off when I told him, which wasn't particularly reassuring. Be warned that this medication can really mess with your head.
1Patient Review
1/3/2020
Singulair for Inflammation of the Nose due to an Allergy
I had a really severe reaction to this drug in the form of hives. I even reported it to the FDA with pictures.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about singulair

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Singulair do for you?

"This drug prevents leukotrienes, which are natural and can cause asthma and allergies, from making breathing difficult by reducing the inflammation in the airways."

Answered by AI

Is Singulair a steroid medication?

"Smith says

You can buy it under its brand name or as a generic. According to Dr. Smith, it blocks certainimmune pathways by preventing the body from making leukotrienes. These are chemicals that contribute to inflammation."

Answered by AI

Why was Singulair taken off the market?

"The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency's most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug. Montelukast is used to treat asthma and seasonal allergies.

The FDA is requiring a boxed warning – the agency's most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug. Montelukast is used to treat asthma and seasonal allergies."

Answered by AI

Why do they recommend taking Singulair at night?

"Asthma symptoms are often worse at night, so Singulair is typically taken then. It usually starts working after the first dose, but some people don't notice a change for up to a week."

Answered by AI

Clinical Trials for Singulair

Have you considered Singulair clinical trials? We made a collection of clinical trials featuring Singulair, we think they might fit your search criteria.Go to Trials
Image of Allergy Immunology Associates in Mayfield Heights, United States.

Osteopathic Manipulative Treatment for Asthma

18 - 60
All Sexes
Mayfield Heights, OH
Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Previous research showed that OMT in asthma patients, can improve the movement of the ribs and improve the "peak flow" which is the maximum rate at which a person can exhale air after taking a deep breath. However, no studies have evaluated the impact of OMT on lung inflammation. This single-site research study at University Hospitals aims to evaluate whether Osteopathic Manipulative Treatment (OMT) can reduce lung inflammation and improve breathing and lung function in adult patients with asthma. The lung function will be evaluated by Spirometry which is a test that measures how much air you can breathe in and out of your lungs, as well as how quickly and easily you can exhale air. The lung inflammation will be measured using a device that can detect how much you are breathing out Nitric Oxide which is a gas produced by inflamed cells in the lungs, this test is called: Fractional exhaled Nitric Oxide or FeNO. Approximately 100 participants will be enrolled.
Waitlist Available
Has No Placebo
Allergy Immunology AssociatesNancy Wasserbauer-Kingston, DO
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Inhaled Corticosteroids + Azithromycin for Asthma

13 - 75
All Sexes
Aurora, CO
While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.
Phase 4
Recruiting
DARTNet Institute (+12 Sites)Wilson D Pace, MD, FAAFP
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Pharmacy Support System for Asthma

Any Age
All Sexes
Ajax, Canada
The goal of this study is to assess the effect of an electronic asthma management system in pharmacies (eAMS-Pharm) on asthma control assessment, asthma medication adjustment, asthma action plan delivery, and prompting for specialist referral in severe asthma. The study assesses the differences on pharmacy processes (affecting both the pharmacy team and patients) and pharmacy-delivered care using an interrupted time-series analysis (six-months before vs. six-months after the introduction of eAMS-Pharm in study pharmacy sites). The eAMS-Pharm uses patient data (asthma control, asthma flare-up risk, and current medications) to provide clinical decision support to pharmacists, empowering them to bridge existing gaps between guideline-recommended asthma care and patient care received.
Waitlist Available
Has No Placebo
Medical Place Pharmacy (+2 Sites)
Image of St. Paul's Hospital in Vancouver, Canada.

Salbutamol for Athletic Performance

18 - 55
All Sexes
Vancouver, Canada
β2-Agonists, commonly used to treat asthma, have also been used by athletes to enhance performance, leading to their ban by the International Olympic Committee in 1972. Research has shown non-asthmatics receive no benefit from these drugs at therapeutic dosages; however, many elite athletes still use them, and asthmatic athletes often win more Olympic medals. In some non-asthmatics, β2-agonists may improve breathing limitations during high intensity exercise, which may improve performance. Therefore, we aim to examine if there is a select group of non-asthmatic individuals who experience breathing limitations that may receive benefit from β2-agonists.
Waitlist Available
Paid Trial
St. Paul's HospitalJordan A Guenette, PhD
Have you considered Singulair clinical trials? We made a collection of clinical trials featuring Singulair, we think they might fit your search criteria.Go to Trials
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PF-07275315 for Asthma

18 - 70
All Sexes
Mobile, AL
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 18 to 70 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 12 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants will be involved in this study for about 9.5 months. During this time, they will have 10 visits at the study clinic.
Phase 2
Recruiting
Velocity Clinical Research, Mobile (+10 Sites)Pfizer CT.gov Call CenterPfizer
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Corticosteroids for Asthma

18+
All Sexes
Hamilton, Canada
Most individuals with asthma can effectively manage their symptoms and maintain normal lung function using inhaled medications, unfortunately, there is a subset of asthma sufferers whose symptoms, lung function, and risk of asthma attacks remain unimproved despite conventional inhaled medications. There could be several reasons for this. One possibility is that inhaled medications fail to reach the intended areas within the lungs, due to structural abnormalities within the airways themselves. Much like road conditions or closures can impede the speed and efficiency of vehicle travel, factors such as airway narrowing or mucus blockages, which are common in asthma, can obstruct the passage of inhaled medications through the airways. Our team has now optimized advanced medical imaging techniques, including magnetic resonance imaging (MRI) and computed tomography (CT), required to investigate this. This study will use these imaging methods to visually assess and measure individual patients' airways and determine whether abnormal airway structures impact how well they respond to inhaled and orally delivered medications. We anticipate finding that abnormal airway structures make inhaled medications less effective, but that they do not affect the response to oral medications.
Phase 4
Recruiting
St. Joseph's Healthcare Hamilton (+1 Sites)
Have you considered Singulair clinical trials? We made a collection of clinical trials featuring Singulair, we think they might fit your search criteria.Go to Trials
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