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Dayvigo (LEMBOREXANT)
Dayvigo blocks the action of orexin, a neurotransmitter that helps regulate sleep-wake cycles.
Dayvigo (LEMBOREXANT) is a small molecule orexin receptor antagonist developed by Eisai Inc, targeting the orexin receptor type 2 to treat insomnia. It was FDA approved in 2019 and remains a patented product with no generic manufacturers. As an orexin receptor antagonist, Dayvigo works by blocking the action of orexin, a neurotransmitter involved in regulating sleep-wake cycles. Key safety considerations include the potential for next-day impairment and the need for caution in patients with a history of substance use disorder. Eisai Inc remains the current owner of the product.
At a glance
| Generic name | LEMBOREXANT |
|---|---|
| Sponsor | Eisai |
| Drug class | Orexin Receptor Antagonist [EPC] |
| Target | Orexin receptor type 2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin and orexin to receptors OX1R and OX2R is thought to suppress wake drive.
Approved indications
- Insomnia
Common side effects
- Somnolence
- Headache
- Nightmare or abnormal dreams
- Sleep paralysis
- Nightmares
- Palpitations
- Hypnagogic hallucinations
- Complex sleep behavior
Drug interactions
- Strong CYP3A inhibitors (e.g., itraconazole, clarithromycin)
- Moderate CYP3A inhibitors (e.g., fluconazole, verapamil)
- Weak CYP3A inhibitors (e.g., chlorzoxazone, ranitidine)
- Strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort)
- Moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil)
- Alcohol
- CYP2B6 substrates (e.g., bupropion, methadone)
Key clinical trials
- Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep (PHASE3)
- Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease (PHASE4)
- Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems (PHASE2)
- Lemborexant in Delayed Sleep Phase Syndrome (PHASE4)
- A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
- Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients (PHASE4)
- Lemborexant Shift Work Treatment Study (PHASE4)
- DORA and LP in Alzheimer's Disease Biomarkers (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dayvigo CI brief — competitive landscape report
- Dayvigo updates RSS · CI watch RSS
- Eisai portfolio CI