What is the recommended dosage and treatment guidelines for Dayvigo (lemborexant) in adults with insomnia?

Recommended Dosage and Treatment Guidelines for Dayvigo (lemborexant) in Adults with Insomnia

Dayvigo (lemborexant) should be initiated at 5 mg taken once daily at bedtime, with the option to increase to 10 mg if needed, and should be taken at least 7 hours before planned awakening to minimize morning drowsiness. 1

Dosage Recommendations

• The recommended starting dose of lemborexant is 5 mg taken orally once per night, immediately before bedtime 1
• Dose may be increased to 10 mg based on clinical response and tolerability 1, 2
• Lemborexant should be taken at least 7 hours before the planned time of awakening to avoid morning drowsiness 1
• Treatment can be maintained long-term as efficacy has been demonstrated for up to 12 months of continuous use 2

Clinical Efficacy

• Lemborexant is effective for both sleep onset and sleep maintenance insomnia in adults 3
• Lemborexant significantly improves:
  • Sleep onset latency (time to fall asleep) 3
  • Sleep efficiency (percentage of time in bed spent sleeping) 3
  • Total sleep time 3, 4
  • Wake after sleep onset (time spent awake during the night) 3
• Benefits are observed as early as the first week of treatment and are sustained through 12 months of continuous use 5, 2

Special Considerations for Older Adults

• Lemborexant has demonstrated efficacy and safety in adults ≥65 years with insomnia disorder 5
• In older adults, lemborexant shows:
  • Significant improvements in subjective sleep onset latency, sleep efficiency, and total sleep time 5
  • Improvements in daytime functioning and reduced fatigue 5
  • Better sleep maintenance in the second half of the night compared to zolpidem extended release 3
• No significant dose adjustments are required based on age 1

Pharmacological Properties

• Lemborexant is a dual orexin receptor antagonist similar to suvorexant 1
• Pharmacokinetic properties:
  • Rapidly absorbed with peak concentration reached in 1-3 hours 1
  • Half-life of 17-19 hours 1
  • Metabolized primarily by CYP3A4/5 1

Adverse Effects and Safety Monitoring

• Most common adverse effects include:
  • Somnolence (approximately 10% at 10 mg dose) 1, 2
  • Headache (2-5%) 1
  • Nightmares (2-5%) 1
• Potential rare adverse effects requiring monitoring:
  • Sleep paralysis 1
  • Hypnagogic/hypnopompic hallucinations 1
  • Cataplexy-like symptoms 1
  • Complex sleep behaviors 1
• Most adverse events are mild to moderate in severity 2
• No evidence of tolerance to sedation or withdrawal effects upon discontinuation has been observed 1, 2

Treatment Context in Insomnia Management

• While the American Academy of Sleep Medicine (AASM) guidelines from 2017 do not specifically mention lemborexant (as it was approved after guideline publication), they do suggest the use of orexin receptor antagonists like suvorexant for sleep maintenance insomnia 6
• Lemborexant, like other pharmacological treatments for insomnia, carries a WEAK recommendation strength according to GRADE methodology used by AASM 6
• The ultimate judgment regarding treatment must be made by the clinician considering individual patient circumstances, available diagnostic tools, and accessible treatment options 6

Monitoring and Follow-up

• Assess treatment response after initiating therapy 5
• Monitor for morning sleepiness, especially when initiating treatment or increasing dose 1
• Evaluate for emergence of depression or suicidal ideation 1
• Consider using standardized assessments such as the Insomnia Severity Index (ISI) to track treatment response 5