Lemborexant
DAYVIGO
What it isDual orexin receptor antagonist; insomnia.
Why this oneIt outperformed extended-release zolpidem on late-night sleep maintenance in older adults.
What limits itNext-morning somnolence, and seven hours must remain before waking. CYP3A4-dependent; Schedule IV.
FDA-approved for
- insomnia (2019)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Insomnia | Adults | 5 mg QHS | 5-10 mg QHS | 10 mg QHS |
Renal Undefined
Hepatic Moderate impairment: max 5 mg QHS; severe impairment: not recommended
No more than once per night
Instructions
- Take immediately before bed with at least 7 hours remaining before planned awakening
- Time to sleep onset may be delayed if taken with or soon after a meal
- Avoid strong/moderate CYP3A inhibitors or inducers; max 5 mg with weak CYP3A inhibitors
Contraindications
- Narcolepsy
Cautions
- CNS depressant effects and next-day impairment (esp. 10 mg; driving)
- Sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms
- Complex sleep behaviors (discontinue immediately)
- Compromised respiratory function
- Worsening of depression / suicidal ideation
Adverse reactions
- Somnolence
Pregnancy No human data; animal toxicity only at high multiples of exposure; registry available
Lactation Transferred into breast milk (low, <2% of maternal dose); monitor infant for excessive sedation
NO BOXED WARNINGS
Principal riskNext-morning somnolence; allow seven hours
Cost, est. cash$300–$2,500/month
Generic entry2035 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityNext-day somnolence, abnormal sleep behaviors and additive CNS depression.
Mechanism of action: Lemborexant ballicule
Open Lemborexant in the interactive console ↗
Memory aids: mascots and interaction avatars
Blocks orexin, allowing sleep
