What is the recommended dose of Singulair (montelukast)?

Singulair (Montelukast) Dosing

The recommended dose of Singulair (montelukast) is 10 mg once daily for adults and adolescents ≥15 years, 5 mg once daily for children 6-14 years, and 4 mg once daily for children 2-5 years, administered in the evening. 1

Adult Dosing (≥15 years)

• 10 mg film-coated tablet once daily 1, 2
• This dose was selected as the lowest dose producing maximal improvement in airway function and patient-reported outcomes in chronic asthma 2
• Should be taken in the evening or at bedtime 3
• Can be taken without regard to meals, though administration with meals may improve gastrointestinal tolerability 4

Pediatric Dosing

Children 6-14 Years

• 5 mg chewable tablet once daily 1, 2
• This dose provides systemic exposure comparable to the adult 10 mg dose based on area under the plasma concentration-time curve 2
• The chewable tablets contain phenylalanine (0.842 mg per 5-mg tablet), which is important for phenylketonuric patients 1

Children 2-5 Years

• 4 mg chewable tablet once daily 1, 5
• This dose has been validated in large multicenter studies showing efficacy and safety in preschool children with persistent asthma 5
• The 4-mg chewable tablet contains 0.674 mg phenylalanine 1
• Clinical benefit is evident within 1 day of starting therapy 5

Infants and Young Children (<2 years)

• Montelukast is not FDA-approved for children under 2 years of age 1
• Safety and efficacy have not been established in this age group 1

Important Clinical Considerations

Timing of Administration

• The long elimination half-life (approximately 24-30 hours) supports once-daily dosing 3
• Do not increase frequency to twice daily - this does not provide additional clinical benefit and may increase adverse effects 3
• Evening administration is specifically recommended based on clinical trial design 3

Special Populations

• No dose adjustment required for patients with normal hepatic and renal function when used with other medications like DayQuil 6
• Patients with moderate renal impairment may require dose adjustment, but the once-daily frequency remains unchanged 3

FDA Black Box Warning

• The FDA issued a black box warning regarding serious neuropsychiatric events including suicidal thoughts or actions 4, 6
• Monitor patients for unusual behavioral or mood changes when starting montelukast 6
• The FDA recommends that benefits may not outweigh risks when symptoms are mild and can be treated with other medications 4

Key Prescribing Points

• Montelukast is not for acute asthma attacks - patients must have short-acting inhaled β-agonist available for rescue 1
• Take daily as prescribed, even when asymptomatic 1
• Do not abruptly discontinue other asthma medications without physician instruction 1
• No tachyphylaxis has been observed after up to 140 weeks of therapy in adults and 80 weeks in children 5

Concomitant Therapy

• Can be safely used with inhaled corticosteroids, with demonstrated additive clinical benefit 1, 7
• No clinically important drug interactions with theophylline, prednisone, oral contraceptives, or other commonly prescribed asthma medications 1
• When used with potent cytochrome P450 enzyme inducers (phenobarbital, rifampin), no dose adjustment is required, but appropriate clinical monitoring is reasonable 1