Prescription medicine
Daridorexant Brand names: Quviviq
Daridorexant (Quviviq) is a prescription medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $16.70 per Quviviq 25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- DEA Schedule IV
Check it at the source: the daridorexant FDA label on DailyMed (effective February 26, 2026, Idorsia Pharmaceuticals Ltd); the NDA 214985 record on Drugs@FDA; every daridorexant label on DailyMed.
Highlights of the record
FDA label of February 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageQUVIVIQ 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
- 25 mg
- 50 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 7, 2022 Quviviq, Idorsia; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- December 2, 2034 Quviviq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $16.70 per tablet Quviviq 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,574 through July 30, 2026
What is daridorexant used for?
From the label: indications and usageQUVIVIQ 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) ]. QUVIVIQ 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 daridorexant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Orexin Receptor Antagonist.
Source: FDA drug label (QUVIVIQ), Idorsia Pharmaceuticals Ltd, effective February 26, 2026 (SPL set 3a2d1503-b816-40c9-9fac-7e03c5a3bcef), via openFDA; the full label on DailyMed
What does the patient leaflet for daridorexant 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 QUVIVIQ?QUVIVIQ may cause serious side effects, including: Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Sleepiness may increase your risk for falls. Do not take more QUVIVIQ than prescribed. Do not take QUVIVIQ unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. Take QUVIVIQ in the evening within 30 minutes before going to bed. See " What are the possible side effects of QUVIVIQ? " for more information about side effects.
From the patient leaflet: What should I avoid while taking QUVIVIQ?Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous. You may still feel drowsy the next day after taking QUVIVIQ. Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you have taken QUVIVIQ as prescribed but do not feel fully awake, you have taken QUVIVIQ and have had less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed by your healthcare provider.
From the patient leaflet: How should I store QUVIVIQ?Store QUVIVIQ at room temperature between 68°F to 77°F (20°C to 25°C). Keep QUVIVIQ and all medicines out of the reach of children.
Source: FDA drug label (QUVIVIQ), Idorsia Pharmaceuticals Ltd, effective February 26, 2026 (SPL set 3a2d1503-b816-40c9-9fac-7e03c5a3bcef), via openFDA; the full label on DailyMed
Is there a generic for daridorexant (Quviviq)?
No generic daridorexant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Quviviq tablets: the compound patent runs to December 2, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for daridorexant (Quviviq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $16.70 per Quviviq 25 mg tablet, up 3% from $16.22 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.
- Quviviq 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Quviviq 25 mg tablet | Brand | $16.70 per tablet | $501.14 | +3% |
| Quviviq 50 mg tablet | Brand | $16.70 per tablet | $501.14 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for daridorexant?
The FDA Adverse Event Reporting System holds 2,574 reports that list daridorexant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 67 are coded as a death and 263 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 rose sharply in 2023 (1,154, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 daridorexant?
11 other medicines are given the same way (oral) and in the same FDA class as daridorexant 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 |
| Lemborexant | Insomnia | none listed | $11.57 per tablet 10 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 daridorexant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to daridorexant
- 11 medicines for the same use
- Other orexin receptor antagonists
- the pharmacologic class, with prices and generics
- Daridorexant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other