Dayvigo (Lemborexant) for Insomnia: Treatment Recommendations
Recommended Dosing
Lemborexant should be prescribed at 5 mg or 10 mg taken once nightly immediately before bedtime, with at least 7 hours remaining before planned awakening. 1
Clinical Context and Evidence Base
The American Academy of Sleep Medicine provides a WEAK recommendation for orexin receptor antagonists like lemborexant in treating sleep maintenance insomnia, meaning clinicians must weigh individual patient circumstances when prescribing. 1 This weak recommendation strength reflects the relative newness of this drug class compared to established benzodiazepine receptor agonists that carry stronger evidence bases from older guidelines. 2
Efficacy Profile
Both the 5 mg and 10 mg doses demonstrate significant improvements across multiple sleep parameters:
Sleep Onset:
- 5 mg reduces sleep onset latency by 9.2 minutes versus placebo 3
- 10 mg reduces sleep onset latency by 12.6 minutes versus placebo 3
Sleep Maintenance:
- 5 mg reduces wake after sleep onset by 19.9 minutes and increases sleep efficiency by 6.1% 3
- 10 mg reduces wake after sleep onset by 22.2 minutes and increases sleep efficiency by 7.5% 3
Sustained Effect Through the Night:
- Both doses significantly reduce wake time in the second half of the night compared to zolpidem extended-release (6.7-8.0 minutes greater reduction), addressing a common limitation of shorter-acting agents 4
Dose Selection Algorithm
Start with 5 mg for:
- Older adults (≥65 years), who showed robust efficacy with this dose 5, 4
- Patients concerned about next-day sedation
- Those taking concomitant CNS depressants
- Patients with hepatic impairment (use caution and lower dose) 2
Consider 10 mg for:
- Younger adults with severe sleep onset difficulties requiring maximal effect 3
- Patients who fail to respond adequately to 5 mg after 1-2 weeks
Both doses show similar tolerability profiles, but the 5 mg dose provides substantial benefit with potentially less somnolence risk. 3
Safety and Tolerability
Common Adverse Effects:
- Somnolence is the most frequent adverse event (typically mild to moderate severity) and occurs approximately 5 times more often than placebo 3
- Treatment-emergent adverse events occur about twice as frequently as placebo 3
- Serious adverse events are rare and generally not treatment-related 4
Next-Day Functioning:
- Lemborexant does not impair morning postural stability, cognitive performance, or driving ability compared to placebo 6
- In contrast to zolpidem (which impaired multiple cognitive measures) and zopiclone (which impaired driving), lemborexant shows a favorable next-day safety profile 6
- Patients report significantly greater morning alertness compared to placebo through 6-12 months of treatment 5, 7
Duration of Treatment
Lemborexant has no short-term usage restriction unlike many benzodiazepines, and efficacy is maintained through 12 months of continuous treatment without evidence of tolerance or rebound insomnia upon discontinuation. 5, 7
Daytime Functioning Benefits
Beyond sleep improvement, lemborexant significantly reduces:
- Insomnia Severity Index total scores and daytime functioning subscores at 1 month (maintained through 6 months) 7
- Fatigue Severity Scale scores by month 3 (maintained through 6 months) 7
These improvements in daytime impairment represent clinically meaningful benefits beyond simply increasing sleep time. 7
Administration Guidelines
- Take on an empty stomach to maximize effectiveness 2
- Avoid alcohol and other CNS depressants due to additive psychomotor effects 2
- Ensure at least 7 hours available for sleep to minimize next-day somnolence risk 2
- Not recommended during pregnancy or nursing 2
Special Populations
Older Adults (≥65 years): Lemborexant demonstrates excellent efficacy and tolerability in this population, with improvements evident from the first week and sustained through 12 months. 5, 4 The 5 mg dose is particularly appropriate as initial therapy.
Patients with Comorbid Conditions: Exercise caution in patients with compromised respiratory function (asthma, COPD, sleep apnea), depression, or hepatic/cardiac disease. 2 Consider lower starting doses in these populations.