Abstract

To the Editors: Montelukast, a leukotriene receptor antagonist, was approved in Spain in 1998 for the treatment of asthma in both adults and children. Sleep disturbances, including nightmares, related to leukotriene receptor antagonists have not been described in clinical trials. However, several cases of sleep abnormalities, including nightmares, have been reported in post-marketing experience in patients treated with montelukast [1]. Up to December 2011, the Spanish System of Pharmacovigilance had gathered 24 reports of nightmares in patients (17 children, seven adults) treated with montelukast (table 1). Of the 24 patients, 15 were males and nine were females. 14 patients presented with other concomitant psychiatric symptoms: insomnia (n=5), nervousness (n=4), hallucinations (n=3), aggressiveness (n=2), irritability (n=2) and anxiety (n=1). Cases with aggressiveness were rated as serious. In all cases the only suspect medicine was montelukast. Six patients had taken other medicines concomitantly, although on a long-term basis. In 18 patients the nightmares appeared within the first …

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