MONTELUKAST (SINGULAIR): MENTAL HEALTH RISK YOU NEED TO KNOW ABOUT

This article is for educational purposes only and should not replace professional medical advice. Always consult with your healthcare provider regarding medication decisions and mental health concerns.

Montelukast, commonly known by its brand name Singulair, is one of the most widely prescribed medications for asthma, allergic rhinitis, and even exercise-induced bronchospasm. As a leukotriene receptor antagonist (LTRA), it has helped millions of people, especially children and adults in regions like South Asia, manage their breathing problems effectively. Many families trust it as a safe, daily treatment.

However, over the past decade, mounting clinical evidence has raised serious concerns about its neuropsychiatric side effects. In March 2020, the U.S. FDA issued a Black Box Warning, the strongest type of warning, for montelukast, citing mental health risks such as depression, anxiety, aggression, nightmares, and even suicidal thoughts, particularly in children and adolescents.

These warnings followed years of case reports and observational studies. Today, understanding these potential side effects is crucial for parents, patients, and healthcare providers to ensure informed decisions are made before starting or continuing montelukast treatment.

Let’s explore the lesser-known but important mental health risks linked to this commonly used asthma medication.

WHAT IS MONTELUKAST AND HOW DOES IT WORK?

Montelukast is a leukotriene receptor antagonist (LTRA) prescribed to treat:
• Asthma
• Allergic rhinitis (hay fever)
• Exercise-induced bronchoconstriction

It works by blocking leukotrienes, inflammatory chemicals in the body that trigger swelling, mucus buildup, and airway tightening, especially in those with asthma or allergies. Montelukast targets the cysteinyl leukotriene receptor type 1 (CysLT1), reducing: airway inflammation, bronchospasm, mucus production, relieves breathing symptoms and improves overall lung function.

WHY IS MONTELUKAST A CONCERN FOR MENTAL HEALTH?

Montelukast has the ability to cross the blood brain barrier. Within 24 hours of use, it can accumulate in brain tissue at higher levels than in other organs. This allows it to interact with brain cells, including neurons and glial cells, possibly altering brain function, raising concerns about mental health side effects such as mood changes, sleep disturbances, and even depression, especially in children and young adults.

HOW DOES MONTELUKAST AFFECT THE BRAIN?

The possible reasons for montelukast affecting the brain are as follows:

• Disruption of neurotransmitters and stress responses
• Oxidative stress on brain cells
• Interference with energy production in neurons
• Action on non-respiratory receptors in the brain

These mechanisms may contribute to the neuropsychiatric effects linked with this asthma and allergy medicine.

THE FDA BLACK BOX WARNING: A TIMELINE OF SAFETY CONCERNS

While montelukast has been prescribed for years, safety concerns have grown:

2008: The FDA received reports of mood changes, irritability, and behavioral issues, and subsequently updated the prescribing information.

MARCH 2020: After reviewing a decade of data, the FDA issued a Black Box Warning due to mental health risks. The review included:
• Case reports from the FDA Adverse Event Reporting System (FAERS)
• Observational studies from the FDA Sentinel System
• Medical literature
• Animal studies on brain effects

The warning listed mental health risks like:
• Mood changes
• Depression
• Anxiety
• Aggression or irritability
• Nightmares or vivid dreams
• Hallucinations
• Sleep disturbances
• Suicidal thoughts or behaviors

Even people with no prior mental health history were affected. Reports continued through 2023 and 2024, especially among children, teens, and young adults.

OVERVIEW OF NEUROPSYCHIATRIC EFFECTS

While montelukast improves breathing, research shows it may also affect the brain and mental health especially in younger users: The following common neuropsychiatric side effects of montelukast have been reported:

• SLEEP PROBLEMS LINKED TO MONTELUKAST

Clinical studies have found that users are more likely to report:
• Insomnia
• Nightmares
• Vivid dreams
• Poor sleep quality
These issues are more common in people taking montelukast than in those not on it.

• ANXIETY AND MOOD CHANGES

Some people report:
• Depression
• Anxiety
• Mood swings
• Irritability
• New need for antidepressants

These symptoms can develop even if you’ve never had mental health issues before taking this asthma medicine.

• SERIOUS MENTAL HEALTH CONCERNS

The FDA has noted rare but serious side effects such as:
• Aggression
• Hallucinations
• Suicidal thoughts or behavior

Over 80 cases of suicide have been linked to montelukast, prompting international concern.

IS MONTELUKAST SAFE FOR CHILDREN?

Children may be more vulnerable to side effects. Parents should look out for:
• Night terrors
• Sudden behavior changes
• Aggression
• Difficulty focusing or learning

These effects may appear soon after starting the medicine.

WHAT ABOUT ADULTS?

While children are more at risk, adults can also experience:
• Mood changes
• Anxiety
• sleep disorders

This confirms that the risks aren’t limited to children alone.

WHAT SHOULD DOCTORS AND PATIENTS DO?

Healthcare providers should follow the following pre-prescription counselling:

• Inform patients and families about potential mental health side effects.
• Assess mental health history before prescribing.
• Monitor closely after starting treatment
• Discontinue or switch treatment if symptoms develop

Patients and families have to monitor the following warning signs:
• Watch for signs like anxiety, mood swings, or nightmares
• Don’t stop the medicine suddenly consult your doctor
• Ask about safer asthma medicine alternatives if needed.

WHEN IS MONTELUKAST STILL USEFUL?

Montelukast may be helpful if:
• Asthma is severe or uncontrolled
• You suffer from exercise-induced asthma
• Other treatments are ineffective or not tolerated
In such cases, benefits may outweigh the risks, but only under close medical supervision.

FINAL THOUGHTS: STAY INFORMED, STAY SAFE

Montelukast has helped many people breathe better, but it’s not without risks. Its link to mental health changes, especially in children and adolescents, should not be ignored.