MONTELUKAST
and neuropsychiatric symptoms
Vega, a medical student, posed a poignant question: “Sir, MONTELUKAST is very commonly prescribed in India for patients with allergy with or without asthma, along with other medicines, whereas in countries like the USA, the UK and Australia it is discretely used. Why ?” Yes, caution is exercised in various countries (due to warnings and regulations) while, in India, this drug is largely used routinely and irrationally with little warning and regulation. It is very common to see Montelukast in the prescriptions given for Allergy / Asthma. The sale of the drug in India increased exponentially -- the annual sales of Montelukast (April 2023–2024) reached over Rs. 2400 crore !
After the publication of various neuropsychiatric side effects, including the suicide of a 14-year-old British teenager Harry Miller in 2018, some countries issued regulatory warnings. Harry Miller died by suicide after struggling to cope with mental health issues for two years. Miller, who had been suffering from asthma, had been prescribed Montelukast on an ongoing basis for two years. In March 2020, the US FDA affixed a black box warning (its strongest type) for Montelukast due to serious mental health side effects. These include agitation, depression, sleep disturbances, hallucinations, anxiety, behavioural changes, and, in some cases, suicidal thoughts, actions, or suicides. The FDA noted that reports continued even after earlier warnings (from 2008/2009), and many healthcare providers/patients were unaware of the risks. They advised restricting use for allergic rhinitis / hay fever to cases where other treatments fail or aren't tolerated, and to weigh benefits vs. risks for asthma, while monitoring patients closely.
Montelukast was developed by Merck and Co in 1990, and was approved by the FDA of USA in 1998. The oral medication was approved to be prescribed daily for long-term use as a “preventer” or “controller” of asthma and allergic rhinitis. There is universal consensus, based on multiple comparative studies, that as a treatment for asthma, the drug is inferior to inhaled corticosteroids, which are considered as the first-line therapy for the control of the disease. For allergic rhinitis, most guidelines across the world recommend intranasal corticosteroids and/or antihistamines; montelukast is not recommended as the first-line therapy. Of course, the steroids have their own side effects. That’s a different story.
The concerns about the neuropsychiatric side effects of Montelukast, including rare cases leading to suicidal thoughts or actions, are valid and well-documented in medical literature and recognised by various international medical regulatory bodies. The side effects include agitation, depression, sleep disturbances, hallucinations, anxiety, behavioural changes, and—in some cases—suicidal thoughts, actions, or suicides. The FDA noted that reports continued even after earlier warnings (from 2008/2009), and that many healthcare providers/patients were unaware of the risks. They advised restricting use for allergic rhinitis / hay fever to cases where other treatments fail or aren't tolerated, and to weigh benefits vs. risks for asthma, while monitoring patients closely.
Alerts similar to that of the FDA exist from other regulators:
- The UK's MHRA (and later updates) reminds prescribers to watch for neuropsychiatric reactions and consider stopping if they occur.
- Australia's TGA (as recently as 2025) strengthened warnings, noting reports of suicidality (including rare fatalities) across age groups.
- Events are generally rare (e.g., suicidal behaviour very rare, <1 in 10,000 in some estimates), but can be serious and persist if not addressed promptly.
Regarding causality and validity:
- Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
- Some large observational studies and systematic reviews find no strong association with suicide/depression overall in asthma patients, though risks may be higher for anxiety, insomnia, or in certain subgroups (e.g., older adults or children in some analyses).
- Recent meta-analyses suggest a modest increased risk for anxiety but not consistently for depression or suicidal behaviours.
- A 2025 study in children/adolescents found no increased risk for neuropsychiatric events.
- Overall, the evidence supports the warnings as precautionary and evidence-based, not that the drug always causes these effects, but that they can occur (sometimes reversibly upon discontinuation), and alternatives should be considered when possible, especially for mild cases.
In India, Montelukast remains widely overused and overprescribed. Some Indian specialists have echoed the global concerns, advising caution or avoiding it in mild cases due to these potential neuro side effects. The core concern is legitimate: Montelukast carries recognized neuropsychiatric risks (including rare suicidality), backed by regulatory actions worldwide. Doctors should discuss these with patients/caregivers, monitor for mood/behaviour changes, and consider alternatives (e.g., inhaled corticosteroids for asthma and intranasal corticosteroids for nasal allergy) if risks outweigh benefits.
If you have the time to waste, click on :
https://drtramaprasad.blogspot.com/2017/04/asthma-allergy-copd_29.html
NEUROPSYCHIATRIC symptoms
In India, the neuropsychiatric symptoms (with or without Montelukast) are not well recognised, not well acknowledged, annd not well documented (both by people and doctors). And there are no broad-based and well-structured comprehensive and robust studies on the subject. Large-scale studies, including the Global Burden of Disease (GBD) study and India's National Mental Health Survey (NMHS 2016) indicate that in 2017 approximately 197.3 million people in India (about 14.3% of the population) had mental disorders.
And it is difficult to come to the conclusion that the symptoms in some cases are due to Montelukast, as the symptoms might have already been present unidentified, and detected during the course of treatment. Many Indian students do have the symptoms due to enormous stress in coping with studies and scoring high marks (marks oriented education with a lot of pressure from parents and others “to do or die”). Studies indicate that even after scoring high marks and getting admitted into a medical college, the stress persists in many cases. "The NATIONAL MEDICAL COMMISSION (NMC) has revealed in August 2024 that an alarming number of MBBS students have MENTAL HEALTH DISORDERS (28%) and suicidal ideation (16%).
This problem is present among other students also, and also among the public. More so, after the onset of the COVID pandemic. Post-COVID (Long COVID) studies in India report neuropsychiatric symptoms (e.g., anxiety 9-13%, depression 9-10%, stress 10%, cognitive issues 5%) in recovered individuals, sometimes affecting 30-40% with persistent symptoms.
Important Notes
- Treatment gaps remain large (often >80% for many conditions like anxiety), due to stigma, access issues, and under-diagnosis.
- Prevalence varies by region (higher in urban/metropolitan areas), gender (e.g., anxiety/depression higher in females; substance use higher in males), socioeconomic status, and age.
- The burden has increased over time (e.g., mental disorders' share of DALYs rose from ~2.5% in 1990 to ~4.7% in 2017), driven by population growth, aging, and lifestyle changes.
These figures highlight a substantial public health challenge in India, with common symptoms like those in depression, anxiety, and substance-related issues being prominent. For the most current or specific sub-population data, consulting recent NMHS updates or GBD reports is recommended.
This seems to be a part of the evolution due to changes in mind set and lifestyle, and the resultant STRESS in life coupled with increasingly unrealistic goals.
Dr. T. Rama Prasad, Perundurai, India
If you have the time to waste, click on :
(1) Mental Health -- https://drtramaprasad.blogspot.com/2023/01/mental-health.html
(2) Stress & Psychosis -- https://drtramaprasad.blogspot.com/2023/01/fear-stress-and-psychosis.html
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