Singulair / Montelukast Psychiatric Injuries

Montelukast, sold as Singulair since 1998, treats asthma and allergies. In March 2020 FDA required a boxed warning, its strongest, about serious mental health side effects, including suicidal thoughts and actions1. FDA also advised that montelukast be reserved for allergic rhinitis patients who cannot use or do not respond to other allergy medicines1. A Singulair lawyer looks at the dates of use, the symptoms and when they started.

What the Singulair boxed warning says

On March 4, 2020, FDA announced it was requiring a boxed warning for montelukast. The warning says serious neuropsychiatric events, which may include suicidal thoughts or actions, have been reported in patients taking it1. The Singulair label tells doctors to discuss benefits and risks, monitor for symptoms and stop the drug right away if they occur2.

For allergic rhinitis, or hay fever, the label says to reserve montelukast for patients who have not responded to or cannot tolerate other treatments, because the benefits may not outweigh the risk2. FDA had communicated about mental health side effects before, in 2008 and 20091.

Neuropsychiatric events FDA listed

FDA's list of reported side effects includes1:

• Agitation, aggression or hostility
• Depression
• Anxiety
• Trouble sleeping, bad or vivid dreams, sleepwalking
• Hallucinations
• Memory or attention problems
• Confusion or disorientation
• Irritability and restlessness
• Obsessive-compulsive symptoms
• Stuttering, tremor or uncontrolled movements
• Suicidal thoughts and actions

What FDA reviewed and newer studies

In its 2020 review, FDA identified 82 reports of completed suicide associated with montelukast, including 19 in people 17 or younger. FDA noted that such reports do not prove the drug caused the deaths. Its own Sentinel study of asthma patients did not find an increased risk of self-harm or hospital-treated depression compared with inhaled steroids1.

Research continues:

• A 2026 pooled study of more than 97,000 children with asthma found montelukast was associated with a higher risk of ADHD (hazard ratio 1.40) and of oppositional defiant and conduct disorders compared with inhaled steroids3.
• A 2026 review of six studies in children found more neuropsychiatric events with montelukast plus inhaled steroids (12.1% vs 8.6%), but the difference was not statistically significant4.

These findings describe groups and are not consistent. They do not show that montelukast caused any one person's symptoms.

The litigation

There is no federal multidistrict litigation for montelukast on the JPML's Nov. 2, 2026 report5. Claims are brought as individual cases. Brand-name and generic montelukast can raise different legal questions, because federal law limits warning claims against generic makers6. A Singulair attorney will ask which product was dispensed.

Who may have a Singulair claim

• Brand Singulair or a generic, and the dates taken
• The age of the person who took it
• What symptoms began, and when compared with the first dose
• Whether symptoms eased after stopping
• Mental health history before the drug
• Hospital, therapy or crisis care that followed

You do not need every record before contacting us. Families of people who died can also ask for a review.

Who may be responsible

An investigation may look at the company that made and labeled the product dispensed, and at what the warning said on the prescription date.

Filing deadlines for Singulair lawsuits

Deadlines depend on your state and on when you learned of the injury and its possible cause. Examples:

• Arizona: generally two years for personal injury and wrongful death7.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect8.
• New York: three years for personal injury9, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body10.
• Texas: two years for personal injury and wrongful death11, and most product liability claims must be brought within 15 years of the product's sale, with an exception for certain latent diseases12.

Claims about injuries to children and wrongful death claims can have their own deadlines. Ask a Singulair attorney to check the rules for your state early.

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Records that help a Singulair review

Records worth gathering

Medicine

• Pharmacy printout showing brand or generic
• Dates started and stopped
• Prescriber notes

Symptoms

• Pediatric or primary care notes
• Therapy or psychiatric records
• ER or hospital records

Daily life

• School or work records
• Notes or messages from the time
• Bills and insurance statements

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Share what you remember about the medicine and the changes you noticed. You do not need every record first.

2. We build the timeline

   We line up the prescription dates with when symptoms began and ended.

3. We gather records

   With your permission, we request pharmacy, medical and billing records from the places that treated you.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

Mental health changes have many causes. A Singulair claim depends on the timeline, the product dispensed and the medical records.

Plain English

Medical, Health & Insurance

Terms you may see in a Singulair case.

Drug terms

Montelukast

A leukotriene receptor antagonist used for asthma and allergies.

Boxed warning

The most serious warning FDA requires on a label.

Symptom terms

Neuropsychiatric event

A change in mood, thinking, sleep or behavior.

Suicidal ideation

Thoughts of suicide.

Care and coverage

Inhaled corticosteroid

A common alternative asthma controller medicine.

Behavioral health coverage

Mental health care health plans must cover on par with medical care in many cases.

Questions

Singulair lawsuit questions

Short answers to the questions people ask first.

Is there a Singulair lawsuit?

Individual claims can be reviewed. There is no federal MDL for montelukast on the current JPML report.

When did Singulair get a boxed warning?

FDA announced the boxed warning requirement on March 4, 2020.

Does generic montelukast count?

It can, but claims against generic makers face different legal limits. A Singulair lawyer will ask which product was dispensed.

My child had nightmares on Singulair. Is that a claim?

Sleep changes are listed side effects. Whether a claim exists depends on severity, duration and records.

Did FDA say montelukast causes suicide?

No. FDA said such events have been reported and required a warning. Its own study did not find increased self-harm risk.

Should we stop montelukast?

Talk with the prescriber. The label says to stop if neuropsychiatric symptoms occur.

How long do I have to file a Singulair lawsuit?

It depends on your state, the age of the person harmed and when the link was discovered.

Can a family bring a claim after a death?

Yes, a Singulair attorney can review a wrongful death claim under your state's rules.

Do symptoms need to be diagnosed?

Medical or counseling records help document what happened and when.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If montelukast was followed by serious changes in mood, sleep or behavior, a Singulair attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about montelukast (Singulair). It is not legal or medical advice and does not create an attorney-client relationship. If someone is in danger, call 911 or 988. Do not stop any medicine without talking to the prescriber. A boxed warning does not by itself establish that the drug caused any person's symptoms. Laws and deadlines differ by state, and no outcome can be promised.