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Montelukast (Singulair) Depression and Mental Health Side Effects

Montelukast (Singulair) Depression and Mental Health Side Effects
Key Takeaways
  • Montelukast (Singulair), an asthma and allergy drug, carries a boxed warning (formerly known as black box warning) assigned by the U.S. Food and Drug Administration (FDA) for serious mental health side effects like anxiety, depression, sleep problems, dream abnormalities, agitation, and even suicidal thoughts and actions.

  • FDA’s boxed warning is the strongest warning for medications that carry severe potential side effects.

Montelukast is a generic drug also sold under the brand name Singulair. This prescription medication is FDA-approved to prevent asthma attacks in adults and children 12 months and older. Montelukast can help with symptoms such as breathing difficulty, wheezing, coughing, and chest tightness. Find out: What to Do for an Asthma Attack Without an Inhaler?

Montelukast works by blocking the effects of chemicals called leukotrienes that cause asthma symptoms. Your body releases leukotrienes when it comes in contact with allergens. This medicine is also used to treat allergic rhinitis (perennial or seasonal). However, montelukast is not the first-choice treatment for asthma and allergy. Many health care professionals prescribe it only after other treatments have proved ineffective because montelukast includes warnings for serious mental health side effects. Check out: “Why Are My Asthma Symptoms Worse In Summer?

Who Can Take Montelukast?

Montelukast is for:

  • Prevention of asthma attacks in adults and children 1 year of age and older.

  • Prevention of exercise-induced asthma (or bronchoconstriction) in adults and children 6 years of age and older.

  • Treatment of seasonal allergic rhinitis (hay fever) in adults and children 2 years of age and older.

  • Treatment of perennial allergic rhinitis (year-round allergies) in adults and children 6 months of age and older.

Check out “What is Adult Asthma? Causes, Symptoms, and Treatments.

Discuss Montelukast Side Effects with Your Doctor

Taking the allergy and asthma drug montelukast can lead to serious mental health side effects and neuropsychiatric events. These side effects may include sleep disturbances, abnormal dreams, depression, anxiety, agitation, hallucinations, irritability, disorientation, and even suicidal thoughts and actions. The FDA requires a boxed warning about serious mental health side effects. It’s important to discuss montelukast and depression with your doctor before starting treatment. 

Learn about more medications that can cause depression.

Safety and Awareness with Montelukast Use

If you are worried about the mental health side effects of montelukast, talk to your doctor. Many other safer medications may be available to treat your condition. Some people are at a higher risk of Singulair’s mental health side effects. For example, those with a history of mental illness. Your health care professional will carefully weigh the benefits versus risks of montelukast before prescribing this drug to you.

“Singulair Ruined My Life”: Personal Accounts and FDA Warnings

Patient Experiences and Stories

There are worries and frustration among people who have been on montelukast long-term for asthma and allergy symptoms and are not aware of how this medication can affect their mood. Talk to your health care professionals today to learn more. Your doctor may discuss a SIngulair alternative with you.

Anecdotal Evidence vs Clinical Study Data

While the mental health side effects of Singulair are serious, you should talk to your doctor if you are concerned and interested in switching to other medications. You should not stop taking any medications without talking to your doctor first. 

The FDA issues warnings or guidelines on montelukast mental health based on clinical study data. They rely on rigorous methods of collecting scientific evidence. Clinical study data is, therefore, more reliable than anecdotal evidence or personal accounts about Singulair.

FDA Statement on Neuropsychiatric Events Related to Montelukast

Given the concerns regarding Singulair and mental health, the FDA has advised healthcare professionals to do the following:

  • Ask patients if they have a history of concomitant neuropsychiatric symptoms prior to starting treatment.

  • Weigh the risks versus benefits of montelukast use in a patient.

  • Inform patients of the risk of Singulair and mental health.

  • Advise patients to stop taking montelukast if they notice any changes in behavior or mood, or suicidal ideation.

  • Monitor patients for mental health changes during treatment with montelukast.

  • Encourage patients to read the medication guide and understand the safety and risks of this medication.

The FDA’s Black Box Warning for Montelukast

In 2020, the U.S. Food and Drug Administration (FDA) issued a black box warning (the strongest type of FDA warning) about the potential mental health risks in patients receiving montelukast. This stronger warning was issued with the aim of strengthening existing warnings for montelukast users.

The FDA states that the asthma and allergy drug montelukast (Singulair) can cause severe neuropsychiatric side effects, including depression and anxiety. The boxed warning advises healthcare providers to avoid prescribing montelukast (Singulair) for mild allergic rhinitis and to use other safer treatments instead. This drug should be reserved for people who have an inadequate response to other safer drugs.

Investigating the Link Between Montelukast and Mental Health

Reports of Depression and Mood Changes in Patients Using Montelukast

In real-life settings, people taking montelukast report an increased incidence of neuropsychiatric adverse drug reactions. This is especially true for children prescribed montelukast. 

Montelukast can cause behavior changes, mood-related changes, aggressive behavior, agitation, confusion, feeling anxious, hallucinations, vivid dreams, depression, disorientation, irritability, memory problems, obsessive-compulsive symptoms, restlessness, and suicidal thinking. In addition, some people also experience uncontrolled muscle movements and tremors on Singulair. 

Review of Scientific Studies and Clinical Trials for Evidence

A study published in the medical journal JAMA found that people taking montelukast for asthma or allergic rhinitis had a higher chance of experiencing anxiety and insomnia compared to people who did not take this drug. Studies have also reported neuropsychiatric events such as depression, nightmares, aggressive behavior, hallucinations, and suicidal behavior.

Laboratory experiments have shown that montelukast crosses the blood-brain barrier and causes changes in the levels of neurotransmitters such as dopamine, serotonin, and GABA. These changes are believed to cause montelukast depression and some of the other mental health side effects associated with this drug. Children, in particular, are at a high risk of Singulair mental health side effects because their brains are still developing.

However, the mental health side effects of montelukast remain controversial. Some meta-analyses have found no link between montelukast use and a significant increase in neuropsychiatric events compared to placebo (inactive medicine). Also, an extensive review did not find any significant associations between montelukast use and suicide events. 

Risk Factors for Developing Mental Health Side Effects on Montelukast

  • Neuropsychiatric events are more likely in children younger than 18 years of age.

  • Older adults may be at a higher risk of neuropsychiatric events such as montelukast anxiety and sleep disorders.

  • People with pre-existing psychiatric disorders, sleep disorders, depression, attention deficit hyperactivity disorder (ADHD), and dementia may be at a higher risk of montelukast depression and mental health side effects.

Montelukast Safety in Children

Generally speaking, neuropsychiatric events caused by montelukast are more frequently reported in children than adults. Infants and children seem to be most likely to suffer from sleep disorders, whereas adolescents and adults have a higher likelihood of suffering from depression, anxiety, suicidal thoughts, and psychosis. 

The oral granules of montelukast (Singulair) can be prescribed to children as young as 6 months old. Studies have found the main adverse effects of this drug in children are sleep disturbances, depression, and anxiety in children under age 12, and depression, anxiety, and suicidal ideation in adolescents. However, there are no case reports of completed suicides directly related to Singulair use.

Symptoms of Montelukast-Induced Depression and Anxiety

Signs of Depression and Anxiety in Montelukast Users

  • Feelings of sadness, hopelessness, emptiness, worthlessness

  • Feeling anxious or worried all the time

  • Tiredness or lack of energy

  • Agitation, restlessness, irritability

  • Memory problems

  • Trouble thinking or making decisions

  • Disorientation or confusion

  • Bad dreams, vivid dreams, or nightmares

  • Sleep difficulties

  • Hallucinations (seeing or hearing things that aren’t there)

Avoid Self-Diagnosis and Get a Professional Evaluation

If you suspect mental health side effects from montelukast, it is important to get a professional opinion from a mental health professional. Self-diagnosis of mental health symptoms can lead to increased feelings of depression and anxiety. It can also increase the risk of self-harm and suicide.

When to Seek Help From Your Healthcare Provider

You should seek help and consult your healthcare provider if you experience symptoms of anxiety and depression persistently for weeks or months. Your doctor may take you off montelukast temporarily to see if your mental health symptoms are related to this drug. Call your health care professional immediately or seek emergency medical care if you have suicidal ideation (thoughts of harming yourself).

Managing Montelukast Side Effects and Protecting Mental Health

Discuss Singulair Alternatives and Treatment Adjustments with Your Healthcare Professional

If you suspect montelukast is causing mental health side effects, talk to your doctor. There are other, safer medications available for asthma and allergy symptoms, such as:

Therapeutic Interventions for Managing Symptoms and Improving Quality of Life

Your healthcare provider can also prescribe medications to manage symptoms of depression and anxiety. There are many different antidepressants and anti-anxiety medications available. In addition, psychotherapy can help to improve your quality of life. These talk therapies help to:

  • Change negative thinking and behavior patterns.

  • Cope with a crisis.

  • Learn ways to interact positively with others.

  • Solve problems in a healthy way.

  • Identify triggers for anxiety and depression and avoid them.

  • Set realistic goals for life.

  • Regain control of your life.

  • Develop resilience to navigate stressful situations.

Best Practices for Monitoring Mental Health While on Singulair Treatment

Montelukast can potentially cause serious neuropsychiatric events. These behavior and mood changes can mimic mental illness symptoms. If you experience any unusual changes in mood or behavior while on Singulair (montelukast), you may be experiencing mental health adverse events. In this case, you should be evaluated by a health care professional without delay.

You can lower your risk of serious mental health side effects on Singulair (montelukast) with the following strategies:

  • Educate yourself on the medication you’re prescribed (montelukast).

  • Read the prescribing information carefully and take montelukast exactly as prescribed. Do not change the dose or dosing frequency without your doctor’s approval.

  • Do not take other prescription or over-the-counter medications without checking with your healthcare provider. Possible drug interactions between montelukast and your other medicines can make side effects worse.

  • Make sure your family and friends know about the mental health risks of montelukast. They should know when and how to seek help if you cannot do so yourself.

Montelukast and Mental Wellness: A Complex Relationship

The Effects of Montelukast on Mental Health

Studies have found that taking montelukast is associated with an increased risk of neuropsychiatric events such as anxiety, depression, sleep disorders, problems with thinking, and suicidal thoughts and behaviors. However, other studies have not found a direct link between Singulair use and mental health side effects. Therefore, the effects of montelukast on mental health remain controversial.

Nonetheless, the U.S. Food and Drug Administration has issued a Black Box Warning for Singulair and generic montelukast. The agency advises restricting the use of this medicine for mild allergic rhinitis that can be treated effectively with alternative therapies. In other words, doctors should not prescribe montelukast when there are other safer, effective allergy medicines.

Patient-Physician Communication is Key

If you are taking montelukast for asthma or allergy symptoms, it is vital that you communicate with your physician. Make sure you understand the mental health risks of montelukast. Work with your doctor to weigh the benefits versus risks of this drug. Tell your doctor immediately if you develop any changes in mood or behavior while on montelukast.

Health care professionals use their clinical judgment to discontinue or continue patients on montelukast (Singulair). They will make sure you understand the potential risks of mental health side effects. Your provider will also tell you to seek emergency medical attention if you develop any changes in mood or behavior, especially thoughts of self-harm. 

Patient Awareness for Safety in Medication Use

Singulair (montelukast) should be reserved as a treatment option for asthma and allergy symptoms that do not respond to other, safer medications. This drug can cause mental health side effects even in healthy patients with no history of mental health disorders. 

If you are taking Singulair, keep these mental health risks in mind, especially if you have pre-existing mental health issues. Discuss other asthma and allergy medicines with your medical professional that may be safer alternatives. Tell your doctor immediately if you notice worsening depression, serious behavior changes, mood-related changes, or other serious mental health side effects of montelukast. A friend or family member should know to seek care for you if you are unable to do so yourself.