Singulair (montelukast) is not available over the counter. It is a prescription-only medication in the United States, and there are no current plans to change that status. The manufacturer, Merck, did apply for over-the-counter approval in 2014, but the FDA’s advisory committee rejected the request.
Why Singulair Remains Prescription-Only
The FDA denied the OTC switch partly because of serious safety concerns that have only grown more prominent since then. In March 2020, the FDA added a Boxed Warning to montelukast, the strongest safety warning the agency can require. The warning highlights mental health side effects including mood changes, behavioral changes, and suicidal thoughts. Completed suicides have been reported in people taking the drug.
These risks are a major reason why montelukast requires a doctor’s oversight. When you fill a prescription, you receive a Medication Guide explaining the potential side effects. Your prescriber can monitor you for mood or behavior changes and weigh whether the benefits justify the risks for your specific situation. That kind of individualized decision-making is exactly what the prescription requirement is designed to protect.
Because of the Boxed Warning, the FDA also restricted when doctors should prescribe montelukast for allergies specifically. For allergic rhinitis (hay fever), it should only be used when other treatments haven’t worked or aren’t tolerated. For asthma and exercise-induced breathing difficulty, the benefit-risk balance is considered more favorable, so it remains a standard option.
What Singulair Is Approved to Treat
Montelukast works differently from the allergy medications you can buy at a pharmacy. It blocks chemicals called leukotrienes, which your immune system releases in response to allergens or exercise. Leukotrienes latch onto receptors in your airways and trigger inflammation, excess mucus, and narrowing of the airway. Montelukast prevents leukotrienes from binding to those receptors, which reduces all three of those effects.
The FDA has approved montelukast for three uses:
- Long-term asthma management in patients 12 months and older
- Prevention of exercise-induced breathing difficulty in patients 6 years and older
- Allergic rhinitis relief, including seasonal allergies in patients 2 years and older and year-round allergies in patients 6 months and older
It comes in regular tablets, chewable tablets, and oral granules depending on the patient’s age.
OTC Alternatives for Allergies
If you’re searching for Singulair over the counter, you’re likely dealing with allergies and hoping to skip a doctor’s visit. Several effective allergy medications are available without a prescription, and for most people with hay fever, these are the recommended first-line treatments anyway.
Second-generation antihistamines like cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) are widely available OTC. They block histamine, a different inflammatory chemical than the leukotrienes that montelukast targets. For most people with seasonal or year-round allergies, antihistamines control sneezing, itching, and runny nose effectively.
Nasal corticosteroid sprays like fluticasone (Flonase) and triamcinolone (Nasacort) are also available over the counter. These reduce inflammation directly inside the nasal passages and are particularly effective for congestion, which antihistamines alone don’t always relieve. Many allergists consider nasal steroid sprays the single most effective OTC option for nasal allergy symptoms.
These OTC options target different parts of the allergic response than montelukast does. For many people, one or a combination of these medications provides sufficient relief. If you’ve tried OTC antihistamines and nasal sprays without adequate results, that’s the situation where a doctor might consider prescribing montelukast, keeping in mind the mental health risks that come with it.
How to Get a Prescription
If you believe you need montelukast specifically, whether for asthma, exercise-induced breathing problems, or allergies that haven’t responded to OTC treatments, you’ll need to see a healthcare provider. Generic montelukast is widely available and significantly less expensive than the brand-name Singulair, which may ease the cost concern that often drives people to look for OTC options. Most pharmacies carry the generic version, and with a prescription, a 30-day supply is typically affordable even without insurance.