What is the recommended lower dose of lamborexant (Dayvigo) for patients with insomnia?

Recommended Lower Dose of Lemborexant (Dayvigo) for Insomnia

The recommended lower dose of lemborexant (Dayvigo) for patients with insomnia is 5 mg taken once per night, immediately before going to bed, with at least 7 hours remaining before planned awakening. 1

Dosing Guidelines and Considerations

• Lemborexant (Dayvigo) is FDA-approved for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance 1
• The starting dose is 5 mg, which may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability 1
• Lemborexant should be taken no more than once per night, immediately before bedtime 1
• The medication should be taken with at least 7 hours remaining before the planned time of awakening to minimize next-day impairment 1

Special Populations Requiring Lower Dosing

• Patients with moderate hepatic impairment: Maximum recommended dose is 5 mg no more than once per night 1
• Patients taking weak CYP3A inhibitors: Maximum recommended dose is 5 mg no more than once per night 1
• Lemborexant is not recommended for patients with severe hepatic impairment 1
• Concomitant use with strong or moderate CYP3A inhibitors or inducers should be avoided 1

Efficacy of Lower Dose (5 mg)

• The 5 mg dose of lemborexant provides significant improvements in:

  • Sleep efficiency (SE) 2
  • Latency to persistent sleep (LPS) 2
  • Wake after sleep onset (WASO) 2
  • Subjective sleep onset latency 2

• In clinical trials, lemborexant doses ranging from 2.5-10 mg provided efficacy for insomnia treatment while minimizing next-morning residual sleepiness 2

Pharmacokinetic Properties of Lower Dose

• Time to maximum concentration for the 5 mg dose ranges from approximately 1-3 hours 3
• The mean effective half-life is 17 hours for lemborexant 5 mg (compared to 19 hours for 10 mg) 3
• There were no clinically relevant effects on next-morning residual sleepiness for doses through 10 mg/day 3

Safety Considerations

• The most common adverse effects with lemborexant include:

  • Somnolence (occurs in approximately 10% at 10 mg dose, less frequent at 5 mg) 4
  • Headache (affects 2-5% of patients) 4
  • Nightmares (affects 2-5% of patients) 4

• Rare but serious adverse effects include:

  • Sleep paralysis 1
  • Hypnagogic/hypnopompic hallucinations 1
  • Cataplexy-like symptoms 1
  • Complex sleep behaviors 4

• Long-term safety data shows that most treatment-emergent adverse events are mild to moderate in severity 5

Clinical Pearls

• Time to sleep onset may be delayed if lemborexant is taken with or soon after a meal 1
• Lemborexant is a CNS depressant that can impair daytime wakefulness even when used as prescribed 1
• Driving ability may be impaired in some subjects taking lemborexant, particularly at the 10 mg dose 1
• Co-administration with other CNS depressants (benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression 1
• Lemborexant has shown effectiveness in treating insomnia with benefits persisting at 12 months of continuous treatment 5