What is the maximum recommended dose of Dayvigo (Lemborexant) for insomnia?

Maximum Dose of Dayvigo (Lemborexant)

The maximum recommended dose of Dayvigo (lemborexant) is 10 mg taken once per night immediately before bedtime, with at least 7 hours remaining before planned awakening.

Dosing Recommendations

• Starting dose: 5 mg once nightly is the recommended initial dose for most adults 1, 2
• Maximum dose: 10 mg once nightly if the 5 mg dose is well-tolerated but insufficiently effective 1, 2
• Do not exceed: 10 mg per night—higher doses (15 mg, 25 mg) were studied but are not FDA-approved, and the 10 mg dose provides optimal efficacy while minimizing next-morning residual sleepiness 1

Clinical Efficacy by Dose

Both the 5 mg and 10 mg doses demonstrate significant improvements in insomnia parameters:

• Sleep onset latency (sSOL): Reduced by 9.23 minutes with 5 mg and 12.56 minutes with 10 mg compared to placebo 2
• Wake after sleep onset (sWASO): Reduced by 19.9 minutes with 5 mg and 22.24 minutes with 10 mg 2
• Sleep efficiency: Increased by 6.08% with 5 mg and 7.46% with 10 mg 2
• Sustained efficacy: Improvements maintained through 12 months of treatment without tolerance development 3

Special Populations

Elderly patients (≥65 years):

• Both 5 mg and 10 mg doses are effective and well-tolerated in older adults 3
• No mandatory dose reduction required, though starting with 5 mg is prudent given increased sensitivity to CNS effects 3
• Improvements in sleep parameters and daytime functioning sustained through 12 months 3

Safety Profile

• Most common adverse event: Somnolence, typically mild to moderate in severity 4, 2
• Somnolence risk: Dose-related, occurring more frequently with 10 mg than 5 mg (RR = 4.95 compared to placebo) 2
• Next-day impairment: Lemborexant does not substantially impair next-morning postural stability, cognitive performance, or driving ability at approved doses 4
• Morning alertness: Significantly improved compared to placebo, sustained through 12 months 3

Critical Dosing Considerations

Timing requirements:

• Take only when at least 7 hours of sleep time is available before planned awakening 4
• Administer immediately before bedtime to minimize risk of next-day somnolence 4

Dose selection rationale:

• The 5 mg dose provides substantial efficacy with lower somnolence risk and should be preferred in patients at higher risk for daytime sedation 2
• Escalate to 10 mg only if 5 mg is insufficient after adequate trial duration 1
• Do not use doses above 10 mg—these were studied (15 mg, 25 mg) but offer no additional benefit over 10 mg while increasing adverse effects 1

Common Pitfalls to Avoid

• Do not exceed 10 mg: Higher doses studied in clinical trials are not approved and increase somnolence without proportional efficacy gains 1
• Do not take with insufficient sleep time: Taking lemborexant with less than 7 hours available for sleep increases risk of next-morning impairment 4
• Do not assume tolerance develops: Unlike older sedative-hypnotics, lemborexant maintains efficacy through at least 12 months without dose escalation 3
• Do not overlook the 5 mg dose: Many patients achieve adequate symptom control with 5 mg, avoiding unnecessary exposure to higher doses and associated somnolence risk 2