Montelukast (Singulair) Timing: Evening Dosing is Recommended

Montelukast should be taken in the evening for optimal effectiveness in asthma management. 1

Evidence for Evening Dosing

Montelukast is typically administered as a once-daily dose in the evening as demonstrated in clinical trials, where efficacy was established with evening dosing without regard to time of food ingestion 1
In the Pediatric Asthma Controller Trial (PACT), children were administered montelukast 5 mg in the evening, which was the standard dosing regimen used in this major clinical trial 2
The FDA-approved drug label for Singulair (montelukast) specifically indicates that efficacy for asthma was demonstrated when montelukast was administered in the evening 1

A study specifically examining the timing of montelukast administration in children with exercise-induced bronchoconstriction found no statistical differences in effectiveness between morning and evening dosing after 2 weeks of treatment 3
However, the majority of clinical trials establishing montelukast's efficacy used evening dosing, including the pivotal trials that led to FDA approval 1, 4
The original Montelukast Clinical Research Study Group trial administered the medication once daily at bedtime, which established the standard dosing pattern 4

The pharmacokinetics of montelukast are similar whether dosed in the morning or evening, but clinical efficacy was established with evening dosing 1
Montelukast reaches peak plasma concentrations in 3-4 hours after oral administration, with a half-life of 2.7-5.5 hours in healthy adults 1
The 5 mg chewable tablet dose for children 6-14 years old was selected to provide comparable drug exposure to the 10 mg tablet used in adults 5

Montelukast is an appropriate alternative therapy for mild persistent asthma in patients who are unable or unwilling to use inhaled corticosteroids 2
Leukotriene receptor antagonists like montelukast have advantages of ease of use and high rates of compliance 2
When used as monotherapy, montelukast is less effective than inhaled corticosteroids for most asthma control outcomes, but still provides significant improvement compared to placebo 2

For optimal adherence and based on established clinical evidence, administer montelukast once daily in the evening 1
If a patient has difficulty with evening administration, morning dosing may be considered as an alternative, though the majority of clinical evidence supports evening dosing 3
Montelukast can be taken without regard to food intake 1
The standard dose is 10 mg for adults and adolescents 15 years and older, 5 mg for children 6-14 years old, and 4 mg for younger children 1, 5, 6

Montelukast should never be used as rescue medication for acute asthma symptoms due to its delayed onset of action 2
Patients should be counseled that montelukast may take several days to reach full effectiveness 1
Montelukast is less effective than inhaled corticosteroids for most asthma control outcomes, so patients with moderate to severe persistent asthma may require additional or alternative controller medications 2
Neuropsychiatric events have been reported with montelukast use, so patients should be monitored for mood changes, behavioral changes, or suicidal thoughts 1