Lemborexant (Dayvigo) Effectiveness for Insomnia
Lemborexant is effective for treating insomnia, with demonstrated improvements in both sleep onset and sleep maintenance that persist for at least 12 months, though the absolute effect sizes are modest. 1, 2
Efficacy Data
Sleep Maintenance (Primary Strength):
- Reduces wake after sleep onset by 16-28 minutes at approved doses (≤20 mg) 3
- Improves total sleep time by approximately 10-22 minutes 3
- Shows greater efficacy for sleep maintenance than sleep onset at lower doses 3
- Helps patients with early morning awakenings 4
Sleep Onset:
- At 20 mg, demonstrates clinically significant reduction in sleep latency 3
- Significantly reduces latency to persistent sleep compared to placebo 2
- In phase 3 trials, showed superiority to zolpidem ER for latency to persistent sleep 2
Long-Term Effectiveness:
- Benefits maintained through 12 months of continuous treatment 1
- No evidence of tolerance development 1
- No rebound insomnia or withdrawal effects upon discontinuation 1
Important Clinical Considerations
Dosing:
- Start at 5 mg, can increase to 10 mg 5
- Must be taken at least 7 hours before planned awakening 5
- Peak concentration occurs 1-3 hours after administration 5
- Half-life: 17-19 hours (longer than suvorexant's 12 hours) 5
Adverse Effects:
- Somnolence: ~7-10% (vs 3% placebo), dose-dependent 3, 5
- Headache: 2-5% 5
- Nightmares: 2-5% 5
- Most adverse events are mild to moderate 1
- Nasopharyngitis was common in long-term studies 1
Serious but Rare Adverse Effects to Monitor:
- Sleep paralysis 5
- Hypnagogic/hypnopompic hallucinations 5
- Cataplexy-like symptoms 5
- Complex sleep behaviors 5
- Emergence of depression or suicidal ideation 5
Next-Day Effects:
- Minimal residual effects on morning alertness 4
- No significant impact on body sway or driving skills 8-9 hours post-administration 6
- Patients can respond to external auditory stimuli during the night 4
Drug Interactions:
- Metabolized by CYP3A4/5 5
- Avoid strong CYP3A4 inhibitors or adjust dose accordingly
- No significant effects from age, sex, or weight 5
Evidence Limitations:
- Not yet studied in major psychiatric disorders 5
- Effect sizes are small to modest, similar to other hypnotics 7
- Long-term safety beyond 12 months remains unknown 1
Comparative Context:
- The American Academy of Sleep Medicine suggests suvorexant (same drug class) primarily for sleep maintenance insomnia with a weak recommendation 3
- Cognitive behavioral therapy for insomnia (CBT-I) remains first-line treatment with better overall value due to fewer harms 7
- FDA recommends pharmacologic therapy for short-term use (4-5 weeks), though lemborexant has demonstrated sustained efficacy beyond this timeframe 7, 1