Neuropsychiatric adverse drug reactions induced by montelukast impair the quality of life in children with asthma.

Introduction: Montelukast-induced neuropsychiatric adverse drug reactions (ADRs) have been reported in retrospective studies. This study aimed to reveal the neuropsychiatric ADRs triggered in patients taking montelukast due to asthma in real time, and to evaluate the effect of these ADRs on quality of life (QoL).
Methods: Patients, ages 3-18 years, taking montelukast for the first time and their parents were included. Ages 3-7 years were defined as the preschool and ages 8-18 years as the school-age group. At the beginning of the study and at the end of the second week of treatment, the neuropsychiatric complaint assessment questionnaire and the KINDL QoL scale were administered to patients and their parents. The effect of ADRs on the decrease in QoL was evaluated by multivariable logistic regression.
Results: Neuropsychiatric ADRs were reported in 78 (62.4%) of 125 patients, who recovered when the drug was discontinued. Temperamental behavior, nightmares and sleep disorders occurred significantly more often in both groups compared with pretreatment ( p  < 0.001 for each). In both groups, except in the child-reported family relationships subscale in the school-age group, significant decreases were found in both child and parent proxy-reported QoL total/sub-scores compared with pretreatment ( p ˂0.001 for each). It was found in the evaluation that the overall QoL of those experiencing ADRs in both age groups was more affected. (Child-reported QoL OR _{preschool age} =2.66, p  = 0.048; OR _school-age =5.95, p  = 0.027; parent-proxy QoL OR _{preschool age} =3.52, p  = 0.010, OR _school-age =6.43, p  = 0.027).
Conclusions: Montelukast-induced neuropsychiatric ADRs are more frequent than reported in the literature and negatively impact children's QoL.