Montelukast is a leukotriene receptor antagonist (LTRA) commonly prescribed for asthma, allergic rhinitis and sleep-related breathing disorders. Recently, some studies have reported several adverse events, such as neuropsychiatric disorders and sleep disturbances, among children. Objective: To obtain more insight into the safety profile of montelukast for children with asthma, allergic rhinitis and sleep-related breathing disorders. Method and results: We retrospectively studied all adverse drug reactions to montelukast among 385 children 6 months or older in six tertiary centers over a two-year period. A total of 89.6% were asthmatic, 50% had allergic rhinitis and 13.6% had sleep-related breathing disorders; Singulair was the most common type of montelukast used (67.9%). This study reported a high prevalence of adverse drug reactions among 123 patients (31.9%), predominantly in those aged 4–9 years (52.8%), followed by adolescents (24.4%) and toddlers (22.8%). Two (ADRs) were reported in 9.8% of the children, while three or more were reported in 5.5%. Sleep disturbance was the most common (ADRs), affecting 15.1% of participants (overlap was common; 5.5% of children experienced sleep difficulties, 4.4% experienced sleep interruption and decreased sleep, and 1.82% experienced nightmares), followed by agitation (10.4%), pain (9.4%) and hyperactivity (6.8%). No serious (ADRs) were reported. Eleven percent of families faced difficulties in purchasing montelukast, and only 57% of families had insurance. Misconceptions were common (9.8% reported it to be a steroid, while 30.6% believed it to be a bronchodilator). Although 81% of the families believed it was an effective and preventive medication, 5.3% stopped the drug due to concern about side effects, especially agitation (3%) and nightmares (0.6%). Conclusion: These data demonstrate that montelukast is effective, but the associated adverse neuropsychiatric drug reactions are more prevalent than those reported in the literature. In particular, sleep disturbance, agitation, pain and hyperactivity were observed. Pediatricians should be aware of such (ADRs). Misconceptions about montelukast are still common, and parental counseling and urgent epidemiological studies are needed to quantify the risk for management plans.

Asthma is a common childhood condition. Its prevalence in Saudi Arabia is high, increasing, and could exceed 20% at the current trajectory. Asthma is a syndrome with different clinical presentations and phenotypes. Many conditions are often misdiagnosed as asthma because they share the same symptoms, particularly coughing and shortness of breath; physical findings, such as wheezing; radiological findings, such as hyperinflation on chest X-ray; or even responses to asthma therapies, as in some patients with bronchiolitis. When treating the younger age group (>5 years old), there should be a high degree of suspicion of alternative causes when evaluating patients presenting with clinical features suggestive of asthma or patients who do not respond well to asthma therapies. This study will highlight common conditions that may mimic asthma and, as a result of incorrect treatment, unnecessarily expose patients to steroids and other therapies for extended periods. Furthermore, we seek to alert healthcare providers to common symptoms and signs that suggest a cause other than asthma and suggest when to refer the patient to subspecialists.