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FDA Medical Review for Singulair10 MG Depression and insomnia were documented in a clinical study (pages 84-86 of the PF or pages 78-80 on the document)
FDA Medical Review for Singulair5 MG Chewable Depression and insomnia were documented in children taking montelukast (Singulair) in a clinical study (page 24 of the PDF or page 21 on the document)
Psychiatric Adverse Effects of Montelukast - A Nationwide Cohort Study (March 20, 2023) Among younger individuals, montelukast use was significantly associated with an increased risk of neuropsychiatric events such as use of neuropsychiatric medicine and hospital treatment. Clinicians should increase awareness of such adverse effects when prescribing montelukast.
This
study confirms the concern of a high prevalence of adverse
neuropsychiatric effects among patients receiving montelukast,
especially agitation, sleep disturbance, pain, and hyperactivity.
Families and physicians should be aware of the (ADRs) of montelukast
when it is prescribed; fortunately, no serious side effects have been
reported. Misconceptions about montelukast are still common; therefore,
education of the families is necessary. Further epidemiological studies
are urgently needed to quantify the risk for management.
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase (June 2022) The nature and potential severity of this adverse drug reaction, as described in these reports, present important knowledge for patients and healthcare providers that could help reduce drug-induced harm. This study highlights the value of post-marketing reports for further characterisation of known adverse drug reactions. The benefit–risk balance should be continuously monitored while patients are taking montelukast.
Analysis of Neuropsychiatric Diagnoses After Montelukast Initiation (May 2022) In this cohort study of electronic health records for 72 490 patients with asthma and 82 456 patients with allergic rhinitis, montelukast was associated with higher odds of incident neuropsychiatric outcomes, including anxiety and insomnia.
This finding suggests that clinicians should consider monitoring for potential mental health symptoms during montelukast treatment.
Neuropsychiatric Event on Withdrawal of Montelukast (March 2022) A 5-year-old-boy was treated for 12 months with montelukast, in combination with inhaled corticosteroids, after a life-threatening asthma attack. The parents were counselled prior to commencement regarding the potential for neuropsychiatric symptoms during treatment with montelukast.
A decision was made by the parents to cease the montelukast a year later as the boy had had an event-free year. Five days after ceasing the montelukast, he developed severe agitation and anxiety, obsession with insects ‘crawling over him’, had nightmares and panic attacks and described auditory hallucinations. He has no prior psychiatric history and had been a well-adjusted social little boy. Over the following 8 weeks, his symptoms gradually improved, although he continued to have nightmares for some months. He required psychology intervention. No other stressors have been identified, nor is there any genetic susceptibility present.
Neuropsychiatric reactions with the use of montelukast (March 2022) A 13 year old boy was started on 5 mg montelukast daily in addition to low dose inhaled corticosteroids to treat his asthma. Within a few days, his mother noted that he was constantly arguing and wanted to hit and kick other people. He had not shown this behaviour earlier. At the time of prescribing, their doctor had asked for any history of psychiatric illnesses in their family, which they had none. The doctor had advised her to observe the child and report any changes in behaviour after starting the drug
Montelukast-induced neuropsychiatric ADRs are more frequent than reported in the literature and negatively impact children’s QoL.
Montelukast and Neuropsychiatric Events in Children with Asthma:
A Nested Case–Control Study (March 2019) “Conclusions: Children prescribed montelukast were almost twice as likely to
experience a new-onset neuropsychiatric event, compared to controls on a
different asthma maintenance therapy. Our findings echo the 2014 FDA’s Pediatric
Advisory Committee recommendations, suggesting increased provider awareness
and continued monitoring of neuropsychiatric adverse events in patients
administered montelukast. Clinicians should be aware of the potential risks of
montelukast, as it may inform their prescribing practices and clinical follow-up
visits.”
Montelukast and Churg-Strauss Syndrome Turkish Respiratory Journal, Füsun Topçu, Levent Akyıldız, Tekin Yıldız, Kenan İltumur, Faruk Oktay, Nihal Kılınç.CSS does not appear to relate to steroid tapering in our patient. Long-term data on these drugs are lacking and leukotriene's role in vasculitis remains to be elucidated. Cardiac involvement in CSS, may present as a serious course. The blockade of the cysteinyl leukotriene receptors could provoke an imbalance in leukotriene receptor stimulation, leading to an increase in circulating LTB4. This leukotriene is a strong chemoattractant for neutrophils and eosinophils and could trigger an eosinophilic state, and thereby intitiate vasculitic involvement.
Churg–Strauss syndrome and leukotriene antagonist use: a respiratory perspective Thorax Online, May 2008, N. Nathani, M A Little, H Kunst, D Wilson, D R Thickett. Authors conclude that based on the available clinical evidence there is a suggestion of a causal relationship between LTA and CSS. Respiratory physicians need to be aware of the risk of CSS when treating patients with asthma with LTAs. Patients should be made aware of the signs and symptoms of CSS after initiation of LTA therapy and they should be regularly monitored for complications.
Montelukast and Churg-Strauss syndrome Swiss Med Weekly, 2004, David Conena, Jörg Leuppib, Lukas Bubendorfc, Anke Ronsdorfa, Michael Tammb, Thomas Hauserd. Almost 150 cases of LRA associated CSS have been reported by the US FDA...An as yet unknown direct pathogenic effect of these drugs appears to be possible...Given the various, inconclusive reports, a controlled study with a large number of patients is needed...clinicians should be aware of this rare but potentially severe complication of LRA.
Churg–Strauss syndrome in two patients receiving montelukast Oxford Journals, Rheumatology 2002, P. Guilpain, J.-F. Viallard, P. Lagarde, P. Cohen, M. Kambouchner, J.L. Pellegrin and L. Guillevin. Both patients presented with CSS after 4–5 months of treatment with montelukast. Neither patient received long-term systemic steroids for asthma, but both were on inhaled steroids.
Montelukast and Churg-Strauss syndrome Thorax online 2002, R Solans, J A Bosch, A Selva, R Orriols, M Vilardell. To our knowledge, no case of CSS relapse has previously been reported in association with leukotriene antagonists.
