Daridorexant
Daridorexant is an orexin receptor antagonist (a sleep medicine that quiets the brain's wake signals) used to treat insomnia in adults who have trouble falling asleep, staying asleep, or both.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Daridorexant: Patient Information Guide
A plain-language walkthrough of Daridorexant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Daridorexant is used for
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Daridorexant is used for one condition:
- Insomnia in adults, including trouble falling asleep and/or staying asleep (Quviviq tablets).
How Daridorexant works
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Daridorexant blocks orexin A and orexin B, natural brain chemicals that promote wakefulness. It does this by binding to the orexin receptors OX1R and OX2R. Blocking these signals is thought to reduce the brain's wake drive, which helps you fall asleep and stay asleep.
How Daridorexant is taken (dosage)
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Quviviq is a tablet taken by mouth, no more than once a night. Take it within 30 minutes before bed, with at least 7 hours left before you plan to wake up.
- A meal can delay when it starts working.
- Your prescriber may use a lower maximum dose if you have moderate liver problems or take certain other medicines.
Follow your prescriber's directions and the label.
Daridorexant side effects in detail
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The most common side effects in studies were:
- Headache
- Sleepiness or fatigue
- Dizziness
- Nausea
Nightmares or abnormal dreams and allergic reactions (including swelling, rash, and hives) have also been reported. Get help right away for swelling of the face or throat, complex sleep behaviors, or worsening depression or suicidal thoughts.
Daridorexant warnings and precautions
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- Daytime impairment: It can reduce alertness and coordination, including the next morning. Effects may last several days after stopping in some people.
- Complex sleep behaviors: Sleepwalking, sleep driving, and similar activities can occur. Stop the medicine immediately if this happens.
- Depression and suicidal thoughts: These may worsen. Use caution if you have symptoms of depression.
- Sleep paralysis, hallucinations, and cataplexy-like symptoms: These can occur.
- Breathing problems: Your doctor should consider this if you have sleep apnea or COPD.
- Falls: Drowsiness raises fall risk, especially in older adults.
- Ongoing insomnia: If it does not improve after 7 to 10 days, you may need to be checked for another medical or mental health cause.
Daridorexant interactions: what it interacts with
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Several medicines and substances can change how daridorexant works or add to its effects.
- Alcohol: adds to impairment, so avoid it.
- Other CNS depressants (benzodiazepines, opioids, tricyclic antidepressants): add to drowsiness.
- Other insomnia medicines: not recommended together.
- Strong CYP3A4 inhibitors: raise levels a lot, so avoid them.
- Moderate CYP3A4 inhibitors: raise levels, so a lower dose is used.
- Strong or moderate CYP3A4 inducers: lower levels and may reduce effect, so avoid them.
- CYP3A4 or P-gp substrate drugs with a narrow safety margin: daridorexant can raise their levels.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Daridorexant
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- Do not use if you have narcolepsy.
- Do not use if you are allergic to daridorexant or any ingredient in Quviviq.
- Tell your doctor about depression or suicidal thoughts.
- Liver problems: lower maximum dose for moderate impairment, and not recommended for severe impairment.
- Breathing conditions such as sleep apnea or COPD.
- Older adults are at higher risk of falls.
- Pregnancy: no human data are available, and a registry monitors outcomes.
- Breastfeeding: low amounts pass into breast milk.
Daridorexant overdose: if you take too much
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In studies, healthy people given up to four times the maximum recommended dose had sleepiness, muscle weakness, cataplexy-like symptoms, sleep paralysis, trouble with attention, fatigue, headache, and constipation. There is no specific antidote, and care is supportive. If you suspect an overdose, call Poison Help at 1-800-222-1222.
Pharmacodynamics: what Daridorexant does in the body
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Daridorexant binds to and blocks both orexin receptors, OX1R and OX2R. At four times the maximum recommended dose, it did not prolong the QTc interval (a heart rhythm measure) to any clinically relevant extent. With alcohol, it added to impairment of balance and alertness.
Pharmacokinetics: how your body processes Daridorexant
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Daridorexant reaches its peak level in the blood within 1 to 2 hours. A high-fat, high-calorie meal delays the peak by about 1.3 hours. Its half-life is about 8 hours. It is mostly broken down by the liver enzyme CYP3A4 and leaves the body mainly in feces, with some in urine, as metabolites. Age, sex, race, body size, and kidney impairment did not have a clinically significant effect on how the body handles it.
How to store Daridorexant
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Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) .
📄 Written from Daridorexant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Daridorexant
195 supplements and herbal products have documented interactions with Daridorexant in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 147
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Daridorexant: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Daridorexant — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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When and how should I take it?
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Can I drive the next day?
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Can I have a drink with it?
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What side effects should I expect, and when should I call?
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Is it safe during pregnancy or breastfeeding?
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Is Daridorexant available over the counter?
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Is Daridorexant a controlled substance?
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When was Daridorexant first available?
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Who makes Daridorexant?
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💬 Answers drafted from Daridorexant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Daridorexant on HelloPharmacist
💊 Daridorexant forms and strengths (how it comes)
Daridorexant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Quviviq is used to treat insomnia in adults, including trouble falling asleep and staying asleep.
- Quviviq is taken by mouth no more than once per night.
- Quviviq should be taken within 30 minutes before bed, with at least 7 hours left before you plan to wake.
- Quviviq may take longer to start working if taken with or soon after a meal.
📊 Daridorexant on the U.S. market: products, makers and brands
How Daridorexant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Daridorexant is used (Medicaid data)
A general measure of how commonly Daridorexant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Daridorexant is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Daridorexant prescribed? Of the 1,597 medications we measure, Daridorexant ranks #786 by Medicaid prescriptions — more than 51% of them.
Utilization by Daridorexant product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
daridorexant 50 MG Oral Tablet Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2599096
daridorexant 25 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2591502
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Daridorexant, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 6 listed Daridorexant NDCs with Medicaid activity.
🔍 Compare Daridorexant products
A representative set of FDA-listed product records for Daridorexant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 25 mg | Oral | Idorsia Pharmaceuticals Ltd × 3 listings | NDA | View NDC → |
| 50 mg | Oral | Idorsia Pharmaceuticals Ltd × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Dasami Lab Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Daridorexant NDCs →
📈 Daridorexant side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Daridorexant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Daridorexant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Daridorexant FDA approval history
How Daridorexant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Daridorexant recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2591497 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2591501In current FDA listings
Look up RxCUI 2591497 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Daridorexant supply and shortage status
Whether Daridorexant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Daridorexant brand names
🏭 Who makes Daridorexant: manufacturers and labelers
Daridorexant drug class (RxNorm)
Daridorexant belongs to the Orexin Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Daridorexant page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Idorsia Pharmaceuticals Ltd is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.