QUVIVIQ 50 MG — DIN 02537443
DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) : 50 MG · IDORSIA PHARMACEUTICALS LTD · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is QUVIVIQ?
QUVIVIQ 50 MG contains DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02537443, held by IDORSIA PHARMACEUTICALS LTD, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 12-Jul-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is QUVIVIQ used for?
QUVIVIQ (daridorexant) is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Daridorexant in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Daridorexant — 2 DINs, of which 1 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| IDORSIA PHARMACEUTICALS LTD | 2 | 1 | QUVIVIQ | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 50 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | QUVIVIQ film-coated tablets are packaged in blisters with 1 or 3 blisters of 10 tablets per carton. |
| Storage | Store at room temperature (between 15 °C and 30 °C). Keep out of reach and sight of children. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Daridorexant |
|---|---|
| ATC code | N05CJ03 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02537443 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2537443 |
| Brand name | QUVIVIQ |
| Generic / active ingredient | DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) : 50 MG |
| Market authorization holder | IDORSIA PHARMACEUTICALS LTD |
| Health Canada schedule | Prescription |
| ATC code | N05CJ03 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N05CJ |
| Current status | MARKETED |
| Status date | 12-Jul-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dose of QUVIVIQ for adults is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening. Some patients may be treated with 25 mg once per night. QUVIVIQ can be taken with or without food, however, sleep onset may be delayed if taken with or soon after a high-fat and high-calorie meal. If a patient forgets to take QUVIVIQ, they should not take it later during the night, otherwise they may feel drowsy in the morning. For patients with moderate hepatic impairment, the recommended dose of QUVIVIQ is 25 mg. Concomitant use of QUVIVIQ with strong inhibitors of CYP3A4 is contraindicated. When co-administering with moderate CYP3A4 inhibitors, the recommended dose is 25 mg. Dose adjustments of QUVIVIQ and/or other CNS-depressant drugs may be required when co-administered due to potentially additive effects. Patients should not consume alcohol in combination with QUVIVIQ.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
QUVIVIQ is contraindicated in: • Patients who are hypersensitive to daridorexant or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Patients with narcolepsy. • Patients taking a concomitant strong CYP3A4 inhibitor.
Warnings and precautions
CNS-depressant effects and Daytime Impairment: Hypnotics including QUVIVIQ may impair daytime wakefulness. Patients should be cautioned about engaging in potentially hazardous activities, driving, or operating heavy machinery unless fully alert. Prescribers should advise patients about next-day somnolence. Caution should be exercised when prescribing QUVIVIQ concomitantly with CNS-depressant medications due to likely additive effects. Patients should not consume alcohol in combination with QUVIVIQ. Sleep paralysis, hallucinations, and cataplexy-like symptoms: These can occur with QUVIVIQ. Prescribers should explain the nature of these events to patients. Comorbid Diagnosis: Treatment of insomnia should be initiated only after careful evaluation. Worsening insomnia or new cognitive/behavioural abnormalities may indicate an underlying psychiatric or medical disorder. Complex Sleep Behaviours: Events such as "sleep driving" and other complex behaviours with amnesia have been reported. Discontinue QUVIVIQ immediately if a patient experiences a complex sleep-related behaviour. Use of alcohol and other CNS-depressants may increase the risk. Patients with thyroid abnormalities: Hypothyroidism and hyperthyroidism symptoms should be addressed in specialized care. Dependence/Tolerance: Daridorexant showed no signs indicative of reinforcing potential or physical dependence in rats. No evidence of withdrawal symptoms upon drug discontinuation in clinical trials. Rebound insomnia: No sign of rebound insomnia was observed upon treatment discontinuation. Driving and Operating Machinery: QUVIVIQ impaired simulated driving performance after first-dose administration. Patients should be cautioned about engaging in potentially hazardous activities, driving, or operating heavy machinery unless fully alert. Hepatic/Biliary/Pancreatic: Not recommended in patients with severe hepatic impairment. Dosage adjustment is recommended in patients with moderate hepatic impairment. Psychiatric: Worsening of depression and suicidal ideation have been reported with hypnotics. QUVIVIQ should be administered with caution in patients with depression. Isolated cases of suicidal ideation have been reported in clinical trials. Respiratory: Patients with compromised respiratory function should receive proper medical attention. QUVIVIQ did not increase apnea-hypopnea events or cause oxygen desaturation in mild/moderate OSA patients. Caution should be exercised when prescribing to patients with severe COPD.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| QUVIVIQ | 25 MG | TABLET | IDORSIA PHARMACEUTICALS LTD | APPROVED | 02537435 |
2 · Same class — other molecules in ATC N05CJ
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Daridorexant | QUVIVIQ | 2 | 1 | Yes |
| Suvorexant | BELSOMRA | 4 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC N05C
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N05CF | Eszopiclone · Zaleplon · Zolpidem · Zopiclone | 125 | 57 |
| N05CD | Estazolam · Flurazepam · Midazolam · Nitrazepam · Temazepam · +1 more | 108 | 21 |
| N05CM | Dexmedetomidine · Ethchlorvynol · Scopolamine · Valerianae Radix | 31 | 11 |
| N05CC | Chloral Hydrate · Paraldehyde | 9 | 1 |
| N05CA | Amobarbital · Barbiturates, Plain · Pentobarbital · Secobarbital | 14 | 0 |
| N05CB | Combinations Of Barbiturates | 2 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is QUVIVIQ called?
Also recorded in Canada as: DARIDOREXANT (GLOBAL), DARIDOREXANT (US), DARIDOREXANT (UK), DARIDOREXANT (JP).
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.