What is a medication like Singulair (montelukast) that doesn't have psychiatric side effects?

Alternative to Montelukast Without Psychiatric Side Effects

For asthma and allergic rhinitis, intranasal corticosteroids are the preferred first-line alternative to montelukast, as they are more effective than montelukast for allergic rhinitis and lack the serious neuropsychiatric risks associated with montelukast. 1

Why Avoid Montelukast

The FDA issued a black box warning in 2020 regarding serious neuropsychiatric events with montelukast, including suicidal thoughts and actions, depression, anxiety, sleep disturbances, and behavioral changes 2, 1. The FDA explicitly states that montelukast's benefits may not outweigh risks, especially when disease symptoms are mild and can be adequately treated with other medications 1. Real-world data shows psychiatric adverse reactions occur in approximately 32% of pediatric patients, with sleep disturbances (15.1%), agitation (10.4%), and hyperactivity (6.8%) being most common 3.

Recommended Alternatives by Condition

For Allergic Rhinitis

• Intranasal corticosteroids are superior to montelukast and should be first-line therapy 1
• Montelukast is less effective than intranasal corticosteroids for allergic rhinitis and should not be considered first-line when intranasal steroids are appropriate 1
• The EPOS2020 steering group does not advise adding montelukast to nasal corticosteroids due to lack of demonstrated benefit 1

For Asthma

• Inhaled corticosteroids (ICS) are the gold-standard therapy for persistent asthma 4
• ICS can be used as monotherapy or in combination with long-acting beta-agonists for better control 4
• When comparing montelukast to ICS in a large observational study (n=457,377), ICS showed comparable or better safety profiles regarding psychiatric outcomes 5

Clinical Decision Algorithm

1. First, determine the primary indication:

   • If allergic rhinitis (with or without asthma): Start intranasal corticosteroids 1
   • If asthma alone: Start inhaled corticosteroids 4

2. Assess disease severity:

   • For mild disease: Avoid montelukast entirely, as safer alternatives are available 1
   • For moderate-to-severe disease: ICS remains preferred over montelukast 4

3. Consider patient-specific factors:

   • Patients with any psychiatric history should absolutely avoid montelukast, as most psychiatric adverse events occur in those with past psychiatric history 5
   • Pediatric patients aged 4-9 years show highest prevalence of adverse reactions to montelukast (52.8%) 3

Key Safety Advantages of Alternatives

Intranasal corticosteroids and inhaled corticosteroids do not carry the black box warning for neuropsychiatric events that montelukast does 2, 1. The psychiatric adverse reactions seen with montelukast—including hallucinations, sleep disturbances, agitation, and suicidal ideation—are not associated with corticosteroid therapy 6, 3.

Common Pitfalls to Avoid

• Do not prescribe montelukast for mild disease when safer alternatives like intranasal or inhaled corticosteroids are available and appropriate 1
• Do not assume montelukast is "just as safe" as other asthma medications—the FDA's black box warning reflects serious documented risks 2, 1
• Do not overlook that montelukast has systemic effects, while inhaled/intranasal corticosteroids act primarily locally with minimal systemic absorption 4