Montelukast and Nightmares: Further Characterisation Using Data from VigiBase

Area of Science:

• Pharmacovigilance
• Neuroscience
• Pediatric Medicine

Background:

• Montelukast is prescribed for asthma management.
• Nightmares are a reported post-marketing adverse drug reaction not detailed in clinical trials.
• Previous literature on montelukast-induced nightmares lacked comprehensive case information.

Purpose of the Study:

• To characterize post-marketing adverse drug reactions of nightmares associated with montelukast.
• To provide additional information to patients and healthcare professionals for safer montelukast use.
• To understand the impact and nature of montelukast-associated nightmares.

Main Methods:

• Clinical review of nightmare reports involving montelukast in VigiBase (WHO global database).
• Analysis of data collected until May 3, 2020.
• Focus on detailed descriptions and impact of reported nightmares.

Main Results:

• 1118 reports of montelukast-associated nightmares were analyzed.
• Many cases reported severe impact on daily life; about half were classified as serious.
• Nightmares predominantly affected children (two-thirds), especially those aged 5-10 years.
• Discontinuation of montelukast led to nightmare resolution in most cases, though sometimes delayed.

Conclusions:

• Montelukast-associated nightmares represent a significant adverse drug reaction with potential severity.
• Post-marketing surveillance is crucial for characterizing known adverse drug reactions.
• Continuous monitoring of the montelukast benefit-risk balance is recommended for patient safety.