Nightmares induced by montelukast in children and adults

Cereza, Glòria; Doladé, Núria Garcia; Laporte, Joan‐Ramon

doi:10.1183/09031936.00092812

Cited by 29 publications

(43 citation statements)

References 5 publications

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“…Because the original clinical trials gathered adverse event information from participants by asking general, open‐ended questions, there could have been underreporting of NE. Our results are also consistent with five other published studies that found no positive association between montelukast and suicidality or depression but do not support the findings of previous studies, mostly based on spontaneous reporting systems that have suggested a possible positive signal for NE with montelukast exposure . None of the studies that found a positive association had a comparison group and only one study used statistical analysis to suggest a strong association between montelukast and psychiatric disorders, particularly sleep disorders, aggressive disorders, and anxiety .…”

Section: Discussionsupporting

confidence: 76%

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Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Ali

O’Brien

Cleves

et al. 2015

Pharmacoepidemiology and Drug

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Section: Discussionsupporting

confidence: 76%

“…The previous evidence regarding an association between montelukast and NE has been mixed . Evidence suggesting a possible positive association between montelukast and NE has identified this risk primarily among children, detecting positive signals as early as 1998 using spontaneous adverse event reporting systems (SRS) .…”

Section: Introductionmentioning

confidence: 99%

Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Ali

O’Brien

Cleves

et al. 2015

Pharmacoepidemiology and Drug

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“…In 21 cases, the nightmares rapidly resolved after montelukast had been discontinued (Cereza et al. ). The relatively high ROR indicates a strong statistical relation between montelukast and nightmares.…”

Section: Discussionmentioning

confidence: 99%

Adverse drug reactions of montelukast in children and adults

Haarman

Hunsel

Vries

2017

Pharmacology Res & Perspec

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Montelukast, a selective leukotriene receptor antagonist, is recommended in guidelines for the treatment of asthma in both children and adults. However, its effectiveness is debated, and recent studies have reported several adverse events such as neuropsychiatric disorders and allergic granulomatous angiitis. This study aims to obtain more insight into the safety profile of montelukast and to provide prescribing physicians with an overview of relevant adverse drug reactions in both children and adults. We retrospectively studied all adverse drug reactions on montelukast in children and adults reported to the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase® until 2016. Depression was reported most frequently in the whole population to the global database VigiBase® (reporting odds ratio (ROR) 6.93; 95% CI: 6.5–7.4). In the VigiBase®, aggression was reported the most in children (ROR, 29.77; 95% CI: 27.5–32.2). Headaches were reported the most frequently to the Dutch database (ROR, 2.26; 95% CI: 1.61–3.19). Furthermore, nightmares are often reported for both children and adults to the Dutch and the global database. Eight patients with allergic granulomatous angiitis were reported to the Dutch database and 563 patients in the VigiBase®. These data demonstrate that montelukast is associated with neuropsychiatric adverse drug reactions such as depression and aggression. Especially in children nightmares are reported frequently. Allergic granulomatous angiitis is also reported, a causal relationship has not been established.

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“…Cereza et al [46] reviewed 24 cases who reported nightmares, both in adults (n = 7) and in children (n = 17). Among them, 14 patients had other concomitant psychiatric symptoms, and in all these cases the suspect medication was montelukast.…”

Section: Psychiatric and Nervous System Disordersmentioning

confidence: 99%

“…Among them, 14 patients had other concomitant psychiatric symptoms, and in all these cases the suspect medication was montelukast. All these symptoms are, however, included in the SPC of montelukast [46]. Four children, aged between 1 and 5 years, developed sleep disorders (i.e.…”

Section: Psychiatric and Nervous System Disordersmentioning

confidence: 99%

Montelukast-Induced Adverse Drug Reactions: A Review of Case Reports in the Literature

Calapai¹,

Casciaro²,

Miroddi³

et al. 2014

Pharmacology

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Background: Montelukast, a leucotriene receptor antagonist, binds the cysteinyl leucotriene type 1 receptor. Montelukast is commonly prescribed to asthma patients as add-on therapy to inhaled corticosteroids. Several clinical trials emphasized that montelukast can be considered a safe drug. However, recent evidence reconsidered the benefit/risk ratio of the use of montelukast for both paediatric and adult patients. Summary: The present review analyzed the previous published case reports regarding montelukast-induced adverse drug reactions (ADRs). They included agitation, anxiety, depression, sleep disturbance, hallucinations, suicidal thinking and suicidality, tremor, dizziness, drowsiness, neuropathies and seizures. The immune system can be involved, in particular, cases of Churg-Strauss syndrome have been published. Furthermore, it can induce hypersensitivity reactions, including anaphylaxis and eosinophilic infiltration. In addition, hepatobiliary, pancreatic and uropoietic disorders have been observed. Some of these cases are characterized by severe prognosis (i.e. neurological deficit and fatal hepatotoxicity). Key Message: The use of montelukast can be burdened by several ADRs, of which physicians should be aware in their clinical practice. A better understanding of the mechanisms causing ADRs after using montelukast could help researchers and clinicians in defining a risk-reduction strategy aimed to lessen montelukast toxicity. More accurate epidemiological studies, in order to discover risk factors favouring montelukast-associated ADRs, are demanded.

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Nightmares induced by montelukast in children and adults

Cited by 29 publications

References 5 publications

Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case‐control study

Adverse drug reactions of montelukast in children and adults

Montelukast-Induced Adverse Drug Reactions: A Review of Case Reports in the Literature

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