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Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

Audience: Pulmonology healthcare professionals

[UPDATED 08/28/2009] The June 12, 2009 Healthcare Professional Sheet has been updated.

FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. FDA recommends that:

  • Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
  • Patients should talk with their healthcare providers if these events occur.
  • Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.


[06/12/2009, Updated 08/28/2009 - Healthcare Professional Sheet - FDA]