The findings of a new study highlight the potential side effects of Singulair, indicating that the popular asthma drug may increase an individual’s chance of suffering from nightmares, depression and aggressive behavior.
Both adults and children who took Singulair (montelukast) frequently reported experiencing neurological side effects, according to research published in the medical journal Pharmacology Research & Perspectives on September 20.
The retrospective study looked at adverse drug reactions among both children and adults taking Singulair in the Netherlands. Reactions were reported to both the Netherlands Pharmacovigilance Center Lareb database and the World Health Organization Global database, VigiBase, until 2016.
Overall, depression was the most frequently reported Singulair side effect for both children and adults, as reported to the worldwide VigiBase. In only children, aggression was the most common side effect reported in VigiBase.
Headaches were reported most frequently to the Netherlands Pharmacovigilance Center database. Nightmares were often reported for both children and adults to both the Dutch and WHO worldwide database.
In 2013, the consumer watchdog group Public Citizen placed Singular on it’s “Do Not Use” list, highlighting the risk of nightmares, hallucinations, insomnia and other psychiatric problems, especially among children. The group also noted that the benefits of Singulair were minimal.
Among other side effects, the Dutch database indicated eight patients reported allergic granulomatous angiitis; whereas 563 reported the condition in the WHO VigiBase.
“These data demonstrate that montelukast is associated with neuropsychiatric adverse drug reactions such as depression and aggression,” the researchers concluded.
In 2009 the FDA ordered a Singulair warning label update, adding information about reports of suicide, suicidal thinking, aggression and other neuropsychiatric side effects.
Singulair belongs to a class of drugs known as selective leukotriene receptor antagonists. It is a pill taken orally once a day to treat asthma, exercise induced asthma and seasonal allergies. It is one of the top selling medications in the U.S., with sales of $3.5 billion in 2008.
Singulair is recommended and prescribed regularly for both children and adults. The manufacturer indicates common side effects include stomach pain, diarrhea, fever, flu-like symptoms, stuffy nose, sinus pain or headache. Other side effects may include skin rashes, ear pain or swelling, severe tingling, and changes in mood or behavior.
The effectiveness of Singulair is commonly debated. Some doctors believe it is not an effective treatment for asthma and other medications should be used instead, especially considering the widespread side effects.
A 2014 study indicated Singular did not prevent wheezing episodes among children who took the medication. In fact, children saw no improvement in wheezing episodes, compared to children who did not take the drug.