Prescription medicine
Lemborexant Brand names: Dayvigo
Lemborexant (Dayvigo) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $11.57 per Dayvigo 10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- DEA Schedule IV
Check it at the source: the lemborexant FDA label on DailyMed (effective February 24, 2025, Eisai Inc.); the NDA 212028 record on Drugs@FDA; every lemborexant label on DailyMed.
Highlights of the record
FDA label of February 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )].
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 20, 2019 Dayvigo, Eisai Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 21, 2035 Dayvigo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.57 per tablet Dayvigo 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,745 through July 30, 2026
What is lemborexant used for?
From the label: indications and usageDAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )]. DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Conditions named in the indications of lemborexant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Orexin Receptor Antagonist.
Source: FDA drug label (DAYVIGO), Eisai Inc., effective February 24, 2025 (SPL set 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd), via openFDA; the full label on DailyMed
What does the patient leaflet for lemborexant say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DAYVIGO?DAYVIGO may cause serious side effects including: Decreased awareness and alertness. The morning after you take DAYVIGO, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. ○ Do not take more DAYVIGO than prescribed. ○ Do not take DAYVIGO unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. ○ Take DAYVIGO right before going to bed. See “What are the possible side effects of DAYVIGO?” for more information about side effects.
From the patient leaflet: What should I avoid while taking DAYVIGO?Do not drink alcohol while taking DAYVIGO. It can increase your chances of getting serious side effects. Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you take DAYVIGO and have had less than a full night of sleep (at least 7 hours) or if you have taken more DAYVIGO than prescribed by your healthcare provider. You may still feel drowsy the next day after taking DAYVIGO. Do not drive or do other dangerous activities until you feel fully awake.
From the patient leaflet: How should I store DAYVIGO?Store DAYVIGO at room temperature between 68°F to 77°F (20°C to 25°C). Keep DAYVIGO and all medicines out of the reach of children.
Source: FDA drug label (DAYVIGO), Eisai Inc., effective February 24, 2025 (SPL set 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd), via openFDA; the full label on DailyMed
Is there a generic for lemborexant (Dayvigo)?
No generic lemborexant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Dayvigo tablets: the compound patent runs to September 20, 2031, and the last listed entry to October 21, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lemborexant (Dayvigo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.57 per Dayvigo 10 mg tablet, up 3% from $11.26 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dayvigo 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dayvigo 10 mg tablet | Brand | $11.57 per tablet | $347.01 | +3% |
| Dayvigo 5 mg tablet | Brand | $11.58 per tablet | $347.33 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the lemborexant label say about other medicines?
The lemborexant label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name lemborexant. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bosentan | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. … inducers: rifampin, carbamazepine, St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil |
| Bupropion | drug interactions | CYP2B6 Substrates Clinical Impact: Concomitant use of DAYVIGO decreases the AUC of drugs that are CYP2B6 substrates, which may result in reduced efficacy for these concomitant medications. … Increasing the doses of CYP2B6 substrates may be considered as needed. Examples: Bupropion, methadone |
| Carbamazepine | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. Intervention: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Dosage and Administration ()]. Examples: Strong CYP3A inducers: rifampin, carbamazepine, St. … |
| Chlorzoxazone | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
| Clarithromycin | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … and Administration ()]. Examples: Strong CYP3A inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
| Efavirenz | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. … rifampin, carbamazepine, St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil |
| Etravirine | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. … carbamazepine, St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil |
| Fluconazole | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … CYP3A inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
| Itraconazole | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … mg [see Dosage and Administration ()]. Examples: Strong CYP3A inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
| Methadone | drug interactions | CYP2B6 Substrates Clinical Impact: Concomitant use of DAYVIGO decreases the AUC of drugs that are CYP2B6 substrates, which may result in reduced efficacy for these concomitant medications. … doses of CYP2B6 substrates may be considered as needed. Examples: Bupropion, methadone |
| Modafinil | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. … St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil |
| Ranitidine | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
| Rifampin | drug interactions | Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy. Intervention: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Dosage and Administration ()]. Examples: Strong CYP3A inducers: rifampin, carbamazepine, St. … |
| Verapamil | drug interactions | Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions. … inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine |
Other labels that name lemborexant
Source: FDA drug label (DAYVIGO), Eisai Inc., effective February 24, 2025 (SPL set 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd), via openFDA; the full label on DailyMed
What do FAERS reports show for lemborexant?
The FDA Adverse Event Reporting System holds 2,745 reports that list lemborexant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 326 are coded as a death and 1,206 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lemborexant?
11 other medicines are given the same way (oral) and in the same FDA class as lemborexant or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Suvorexant | Insomnia | none listed | $15.21 per tablet 10 mg tablet | No current entry |
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Ramelteon | Insomnia | 27 labelers | $0.660 per tablet 8 mg tablet | A presentation being discontinued |
| Zaleplon | Insomnia | 9 labelers | $0.141 per capsule 10 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
Every medicine labeled for the same conditions as lemborexant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lemborexant
- 11 medicines for the same use
- Other orexin receptor antagonists
- the pharmacologic class, with prices and generics
- Lemborexant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other