On December 22, 2025, China’s National Medical Products Administration (NMPA) issued an announcement requiring unified revisions to the labeling of montelukast preparations, adding a warning about severe neuropsychiatric adverse reactions such as depression and suicidal ideation associated with the drug. Montelukast sodium is a commonly used antitussive and antiasthmatic medication, primarily indicated for asthma and allergic rhinitis, and is especially widely prescribed for children. The revision is based on the results of adverse drug reaction assessments, aiming to further safeguard public medication safety. This means patients must pay closer attention to changes in their mental state while taking such drugs and seek medical attention promptly if abnormalities occur.

I. Indications and Mechanism of Action of Montelukast Sodium

Primary Therapeutic Uses: Montelukast sodium is mainly used for the prevention and treatment of asthma, including the prevention of daytime and nighttime asthma symptoms, treatment of aspirin-sensitive asthma patients, and prevention of exercise-induced bronchoconstriction. It is also indicated for relieving symptoms of seasonal and perennial allergic rhinitis, such as nasal congestion, rhinorrhea, and sneezing.

Mechanism of Action: Montelukast sodium is a selective cysteinyl leukotriene receptor antagonist that inhibits leukotriene-mediated airway inflammatory responses. Leukotrienes are potent inflammatory mediators that trigger airway reactions such as bronchoconstriction, increased mucus secretion, and enhanced vascular permeability. By blocking the binding of leukotrienes to their receptors, the drug exerts anti-inflammatory and antiallergic effects, thereby alleviating asthma and allergic rhinitis symptoms.

Populations Indicated: The drug is suitable for children aged 1 year and above, as well as adults. The 4mg granules are for asthmatic children aged 1–5 years and children with allergic rhinitis aged 2–5 years; 4mg chewable tablets are for children aged 2–5 years; 5mg chewable tablets are for children aged 6–14 years; and 10mg tablets are for adults aged 15 years and above. Different formulations correspond to different age groups and must be used in accordance with the labeling or medical advice.

II. Specific Content and Significance of the New Warning

Warning Content: According to the NMPA announcement, the "Warning" section of the montelukast preparation labeling must include: Neuropsychiatric adverse reactions have been reported in patients of all ages taking montelukast, including rare severe reactions such as depression and suicidal ideation; these symptoms may persist if the drug is not discontinued. If neuropsychiatric symptoms occur during montelukast treatment, the drug should be discontinued and medical attention sought. Patients or caregivers are advised to remain vigilant for neuropsychiatric adverse reactions and inform physicians if such symptoms develop during treatment.

Updated Adverse Reactions: The "Adverse Reactions" section of the labeling should include: "Post-marketing experience: Psychiatric disorders should include 'stuttering'". This means stuttering has been officially listed as a neuropsychiatric adverse reaction of the drug and requires attention.

Revision Timeline: All marketing authorization holders must complete labeling revisions and submit filings by March 12, 2026. Within 9 months of filing, they must replace the labeling and packaging inserts of already manufactured drugs or inform patients of updated information through other means. This means montelukast preparations on the market will use the new labeling starting from the second half of 2026.

III. Medication Safety Precautions

Close Monitoring of Psychiatric Symptoms: During montelukast sodium treatment, patients and their families should closely monitor for the following neuropsychiatric adverse reactions: anxiety, depression, low mood, irritability, aggressive behavior, restlessness, insomnia, nightmares, hallucinations, attention disorders, and paresthesia. Pediatric patients are particularly prone to symptoms such as irritability and attention abnormalities. If these symptoms occur, discontinue the drug immediately and seek medical attention.

Caution in Special Populations: Patients with a history of psychiatric illness must use the drug with extreme caution under close medical supervision. Children and adolescents are high-risk groups for neuropsychiatric adverse reactions, and parents should pay special attention to changes in their children’s mood and behavior. Pregnant and lactating women should use the drug under medical guidance and avoid it unless clearly necessary.

Correct Administration Methods: The drug is generally recommended for bedtime administration, as the vagus nerve is more active at night, easily triggering tracheal spasms; bedtime dosing can prevent nocturnal asthma attacks. For the prevention of exercise-induced asthma, it should be taken at least 2 hours before exercise. Granules must be dissolved in light-protective vehicles (e.g., formula milk) and not taken with plain water, and should be consumed within 15 minutes of opening the package.

Avoid Misuse: Montelukast sodium should not be used as a first-line drug for allergic rhinitis or asthma. For allergic rhinitis, antihistamines (e.g., loratadine, cetirizine) or intranasal corticosteroids (e.g., fluticasone, budesonide) should be prioritized. Montelukast sodium should only be considered when other treatments are ineffective or intolerable. Asthma patients should use the drug under standardized medical guidance.

IV. Special Reminders for Pediatric Medication

Higher Susceptibility to Adverse Reactions in Children: Children are the primary users of montelukast sodium and also high-risk groups for neuropsychiatric adverse reactions. When administering the drug to children, parents must carefully observe changes in their mood and behavior, such as irritability, aggressive behavior, inattention, and sleep disturbances. If abnormalities are detected, discontinue the drug immediately and consult a doctor.

Avoid Arbitrary Use of Antitussives: Coughing is a protective reflex of the respiratory tract that helps clear secretions and foreign bodies. For children with productive cough, expectorants (e.g., ambroxol, bromhexine) should be prioritized; potent antitussives should be avoided to prevent airway obstruction from retained sputum and subsequent difficulty breathing. Potent antitussives should only be used under medical guidance for paroxysmal severe dry cough or frequent coughing that disrupts rest.

Indications for Immediate Medical Attention: If a child under 4 months old develops a cough, or if coughing is accompanied by difficulty breathing, poor mental status, vomiting after severe coughing, or if the cough persists for more than 2 weeks without improvement, parents should immediately take the child to a formal hospital for treatment and avoid self-medication.

V. Selection of Other Common Antitussives

Medications for Dry Cough: For non-productive dry cough, central antitussives such as dextromethorphan and pentoxyverine may be used. Dextromethorphan is a commonly used antitussive with a wide safety margin, but adults should not exceed 120mg within 24 hours; overdose may cause confusion, bronchospasm, and respiratory depression, and long-term high-dose use may lead to drug addiction and psychological dependence.

Medications for Productive Cough: For productive cough, expectorants such as ambroxol and bromhexine should be prioritized. Ambroxol breaks down mucopolysaccharide protein fibers in sputum, reduces secretion viscosity, and promotes sputum excretion. Expectorants dissolve and dilute sticky sputum and enhance ciliary movement to facilitate sputum expulsion; concurrent use with potent antitussives may cause airway obstruction from retained sputum and lead to difficulty breathing.

Chinese Patent Medicine Options: Chinese patent medicines such as Lianhua Qingke Tablets, composed of pure Chinese herbal ingredients, have high safety profiles and no dependence or addiction. They inhibit airway inflammation, protect airway mucosa, reduce airway hyperresponsiveness, decrease sputum production, dilute sputum, and promote sputum excretion, effectively relieving cough and expectoration caused by various respiratory diseases such as colds, pharyngitis, and tracheobronchitis.

The NMPA’s revision of montelukast preparation labeling reflects a high priority on public medication safety. While montelukast sodium effectively treats asthma and allergic rhinitis, it may cause severe neuropsychiatric adverse reactions such as depression and suicidal ideation, requiring full vigilance from doctors, patients, and their families. Strict adherence to medical advice is essential before use, and close monitoring of psychiatric symptoms during treatment is necessary; immediate drug discontinuation and medical attention are required if abnormalities occur. Additionally, misuse of the drug should be avoided, and safer alternatives should be prioritized for allergic rhinitis and asthma. Remember: medication safety is paramount, and scientific medication use is the key to protecting health.

On December 22, 2025, China’s National Medical Products Administration (NMPA) issued an announcement requiring unified revisions to the labeling of montelukast preparations, adding a warning about severe neuropsychiatric adverse reactions such as depression and suicidal ideation associated with the drug. Montelukast sodium is a commonly used antitussive and antiasthmatic medication, primarily indicated for asthma and allergic rhinitis, and is especially widely prescribed for children. The revision is based on the results of adverse drug reaction assessments, aiming to further safeguard public medication safety. This means patients must pay closer attention to changes in their mental state while taking such drugs and seek medical attention promptly if abnormalities occur.

I. Indications and Mechanism of Action of Montelukast Sodium

Primary Therapeutic Uses: Montelukast sodium is mainly used for the prevention and treatment of asthma, including the prevention of daytime and nighttime asthma symptoms, treatment of aspirin-sensitive asthma patients, and prevention of exercise-induced bronchoconstriction. It is also indicated for relieving symptoms of seasonal and perennial allergic rhinitis, such as nasal congestion, rhinorrhea, and sneezing.

Mechanism of Action: Montelukast sodium is a selective cysteinyl leukotriene receptor antagonist that inhibits leukotriene-mediated airway inflammatory responses. Leukotrienes are potent inflammatory mediators that trigger airway reactions such as bronchoconstriction, increased mucus secretion, and enhanced vascular permeability. By blocking the binding of leukotrienes to their receptors, the drug exerts anti-inflammatory and antiallergic effects, thereby alleviating asthma and allergic rhinitis symptoms.

Populations Indicated: The drug is suitable for children aged 1 year and above, as well as adults. The 4mg granules are for asthmatic children aged 1–5 years and children with allergic rhinitis aged 2–5 years; 4mg chewable tablets are for children aged 2–5 years; 5mg chewable tablets are for children aged 6–14 years; and 10mg tablets are for adults aged 15 years and above. Different formulations correspond to different age groups and must be used in accordance with the labeling or medical advice.

II. Specific Content and Significance of the New Warning

Warning Content: According to the NMPA announcement, the "Warning" section of the montelukast preparation labeling must include: Neuropsychiatric adverse reactions have been reported in patients of all ages taking montelukast, including rare severe reactions such as depression and suicidal ideation; these symptoms may persist if the drug is not discontinued. If neuropsychiatric symptoms occur during montelukast treatment, the drug should be discontinued and medical attention sought. Patients or caregivers are advised to remain vigilant for neuropsychiatric adverse reactions and inform physicians if such symptoms develop during treatment.

Updated Adverse Reactions: The "Adverse Reactions" section of the labeling should include: "Post-marketing experience: Psychiatric disorders should include 'stuttering'". This means stuttering has been officially listed as a neuropsychiatric adverse reaction of the drug and requires attention.

Revision Timeline: All marketing authorization holders must complete labeling revisions and submit filings by March 12, 2026. Within 9 months of filing, they must replace the labeling and packaging inserts of already manufactured drugs or inform patients of updated information through other means. This means montelukast preparations on the market will use the new labeling starting from the second half of 2026.

III. Medication Safety Precautions

Close Monitoring of Psychiatric Symptoms: During montelukast sodium treatment, patients and their families should closely monitor for the following neuropsychiatric adverse reactions: anxiety, depression, low mood, irritability, aggressive behavior, restlessness, insomnia, nightmares, hallucinations, attention disorders, and paresthesia. Pediatric patients are particularly prone to symptoms such as irritability and attention abnormalities. If these symptoms occur, discontinue the drug immediately and seek medical attention.

Caution in Special Populations: Patients with a history of psychiatric illness must use the drug with extreme caution under close medical supervision. Children and adolescents are high-risk groups for neuropsychiatric adverse reactions, and parents should pay special attention to changes in their children’s mood and behavior. Pregnant and lactating women should use the drug under medical guidance and avoid it unless clearly necessary.

Correct Administration Methods: The drug is generally recommended for bedtime administration, as the vagus nerve is more active at night, easily triggering tracheal spasms; bedtime dosing can prevent nocturnal asthma attacks. For the prevention of exercise-induced asthma, it should be taken at least 2 hours before exercise. Granules must be dissolved in light-protective vehicles (e.g., formula milk) and not taken with plain water, and should be consumed within 15 minutes of opening the package.

Avoid Misuse: Montelukast sodium should not be used as a first-line drug for allergic rhinitis or asthma. For allergic rhinitis, antihistamines (e.g., loratadine, cetirizine) or intranasal corticosteroids (e.g., fluticasone, budesonide) should be prioritized. Montelukast sodium should only be considered when other treatments are ineffective or intolerable. Asthma patients should use the drug under standardized medical guidance.

IV. Special Reminders for Pediatric Medication

Higher Susceptibility to Adverse Reactions in Children: Children are the primary users of montelukast sodium and also high-risk groups for neuropsychiatric adverse reactions. When administering the drug to children, parents must carefully observe changes in their mood and behavior, such as irritability, aggressive behavior, inattention, and sleep disturbances. If abnormalities are detected, discontinue the drug immediately and consult a doctor.

Avoid Arbitrary Use of Antitussives: Coughing is a protective reflex of the respiratory tract that helps clear secretions and foreign bodies. For children with productive cough, expectorants (e.g., ambroxol, bromhexine) should be prioritized; potent antitussives should be avoided to prevent airway obstruction from retained sputum and subsequent difficulty breathing. Potent antitussives should only be used under medical guidance for paroxysmal severe dry cough or frequent coughing that disrupts rest.

Indications for Immediate Medical Attention: If a child under 4 months old develops a cough, or if coughing is accompanied by difficulty breathing, poor mental status, vomiting after severe coughing, or if the cough persists for more than 2 weeks without improvement, parents should immediately take the child to a formal hospital for treatment and avoid self-medication.

V. Selection of Other Common Antitussives

Medications for Dry Cough: For non-productive dry cough, central antitussives such as dextromethorphan and pentoxyverine may be used. Dextromethorphan is a commonly used antitussive with a wide safety margin, but adults should not exceed 120mg within 24 hours; overdose may cause confusion, bronchospasm, and respiratory depression, and long-term high-dose use may lead to drug addiction and psychological dependence.

Medications for Productive Cough: For productive cough, expectorants such as ambroxol and bromhexine should be prioritized. Ambroxol breaks down mucopolysaccharide protein fibers in sputum, reduces secretion viscosity, and promotes sputum excretion. Expectorants dissolve and dilute sticky sputum and enhance ciliary movement to facilitate sputum expulsion; concurrent use with potent antitussives may cause airway obstruction from retained sputum and lead to difficulty breathing.

Chinese Patent Medicine Options: Chinese patent medicines such as Lianhua Qingke Tablets, composed of pure Chinese herbal ingredients, have high safety profiles and no dependence or addiction. They inhibit airway inflammation, protect airway mucosa, reduce airway hyperresponsiveness, decrease sputum production, dilute sputum, and promote sputum excretion, effectively relieving cough and expectoration caused by various respiratory diseases such as colds, pharyngitis, and tracheobronchitis.

The NMPA’s revision of montelukast preparation labeling reflects a high priority on public medication safety. While montelukast sodium effectively treats asthma and allergic rhinitis, it may cause severe neuropsychiatric adverse reactions such as depression and suicidal ideation, requiring full vigilance from doctors, patients, and their families. Strict adherence to medical advice is essential before use, and close monitoring of psychiatric symptoms during treatment is necessary; immediate drug discontinuation and medical attention are required if abnormalities occur. Additionally, misuse of the drug should be avoided, and safer alternatives should be prioritized for allergic rhinitis and asthma. Remember: medication safety is paramount, and scientific medication use is the key to protecting health.