APO-ZOLPIDEM ODT 10 MG — DIN 02434946
ZOLPIDEM TARTRATE : 10 MG · APOTEX INC · TABLET (ORALLY DISINTEGRATING) · wholesale supply in Canada
Health Canada status: MARKETED
What is APO-ZOLPIDEM ODT?
APO-ZOLPIDEM ODT 10 MG contains ZOLPIDEM TARTRATE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02434946, held by APOTEX INC, supplied as TABLET (ORALLY DISINTEGRATING) for SUBLINGUAL administration. Health Canada currently lists it as marketed, status dated 13-Feb-2015. 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 APO-ZOLPIDEM ODT used for?
Short-term (7-10 days) treatment and symptomatic relief of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Zolpidem cost around the world?
Zolpidem is listed on 11 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Greece publishes a producer price (ex-factory); Iceland publishes a max wholesale; Morocco publishes a PPV (public price). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Sweden | AIP (pharmacy purchase price) | 8 | 38 | SEK███.██ |
| United States | acquisition | 3 | 28 | USD███.██ |
| Slovakia | categorised final price | 7 | 14 | EUR███.██ |
| South Africa | single exit price | 8 | 12 | ZAR███.██ |
| Morocco | PPV (public price) | 3 | 6 | MAD███.██ |
| Romania | max producer price | 2 | 6 | RON███.██ |
| Saudi Arabia | public | 4 | 4 | SAR███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Spain | PVP con IVA (public price) | 1 | 1 | EUR███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
113 pack listings across 40 brand entries and 11 price bases, refreshed 05 Sep 2026. Ranges span every Zolpidem pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Zolpidem 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.
8 holders have a Canadian DIN containing Zolpidem, across 18 DINs, of which 12 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| BAUSCH HEALTH, CANADA INC. | 4 | 2 | SUBLINOX, ZOLPIDEM TARTRATE ODT | Sourceable in Canada |
| APOTEX INC | 2 | 2 | APO-ZOLPIDEM ODT | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 2 | 2 | JAMP ZOLPIDEM ODT | Sourceable in Canada |
| MINT PHARMACEUTICALS INC | 2 | 2 | MINT-ZOLPIDEM ODT | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-ZOLPIDEM ODT | Sourceable in Canada |
| PRO DOC LIMITEE | 2 | 2 | PRO-ZOLPIDEM ODT | Sourceable in Canada |
| ANGITA PHARMA INC. | 2 | 0 | AG-ZOLPIDEM ODT | No marketed DIN |
| SANOFI-AVENTIS CANADA INC | 2 | 0 | IVADAL | No marketed DIN |
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 | 10 MG |
|---|---|
| Dosage form | TABLET (ORALLY DISINTEGRATING) |
| Route | SUBLINGUAL |
| Pack configuration (monograph) | Blister packs of 30; Bottles of 30, 100, and 500 tablets. |
| Storage | Store at 15-30°C. (Note: Standard pharmaceutical storage based on monograph context, though specific text was truncated). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Zolpidem |
|---|---|
| ATC code | N05CF02 |
| AHFS class | 28:24.92 |
| 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) | 02434946 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2434946 |
| Brand name | APO-ZOLPIDEM ODT |
| Generic / active ingredient | ZOLPIDEM TARTRATE : 10 MG |
| Market authorization holder | APOTEX INC |
| Health Canada schedule | TARGETED SUBSTANCES (CDSA IV) |
| ATC code | N05CF02 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N05CF |
| Current status | MARKETED |
| Status date | 13-Feb-2015 |
| Original market date | 2015-02-13 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Take once per night immediately before bedtime with 7-8 hours before awakening. Sublingual ODT should be placed under the tongue; do not swallow, chew, or take with water. Max 10 mg/day.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to zolpidem; obstructive sleep apnoea; severe respiratory impairment; myasthenia gravis; severe hepatic impairment; history of complex sleep behaviours or sleepwalking.
Warnings and precautions
Risk of addiction, abuse, and misuse; complex sleep-related behaviours (e.g., sleep-driving); CNS depression and next-day impairment; risks from concomitant use with opioids.
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
12 of 18 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | APOTEX INC | MARKETED | 02436159 |
| JAMP ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | JAMP PHARMA CORPORATION | MARKETED | 02540606 |
| JAMP ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | JAMP PHARMA CORPORATION | MARKETED | 02540592 |
| MINT-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | MINT PHARMACEUTICALS INC | MARKETED | 02472848 |
| MINT-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | MINT PHARMACEUTICALS INC | MARKETED | 02472821 |
| PMS-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | PHARMASCIENCE INC | MARKETED | 02436183 |
| PMS-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | PHARMASCIENCE INC | MARKETED | 02436175 |
| PRO-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | PRO DOC LIMITEE | MARKETED | 02537346 |
| PRO-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | PRO DOC LIMITEE | MARKETED | 02537354 |
| SUBLINOX | 5 MG | TABLET (ORALLY DISINTEGRATING) | BAUSCH HEALTH, CANADA INC. | MARKETED | 02391678 |
2 · Same class — other molecules in ATC N05CF
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Zopiclone | ACT ZOPICLONE · AG-ZOPICLONE · APO-ZOPICLONE · AVA-ZOPICLONE · +31 more | 94 | 36 | Yes |
| Zolpidem | AG-ZOLPIDEM ODT · APO-ZOLPIDEM ODT · IVADAL · JAMP ZOLPIDEM ODT · +5 more | 18 | 12 | Yes |
| Eszopiclone | LUNESTA · M-ESZOPICLONE · MAR-ESZOPICLONE | 9 | 9 | Yes |
| Zaleplon | STARNOC | 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 |
|---|---|---|---|
| N05CD | Estazolam · Flurazepam · Midazolam · Nitrazepam · Temazepam · +1 more | 108 | 21 |
| N05CM | Dexmedetomidine · Ethchlorvynol · Scopolamine · Valerianae Radix | 31 | 11 |
| N05CC | Chloral Hydrate · Paraldehyde | 9 | 1 |
| N05CJ | Daridorexant · Suvorexant | 6 | 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 APO-ZOLPIDEM ODT called?
The same molecule, Zolpidem, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Zolpidem Orifarm | Latin | Sweden |
| Zolpidem ratiopharm | Latin | Sweden |
| Zolpidem Forza | Latin | Sweden |
| Stilnoct | Latin | Iceland, Sweden |
| Zolpinox | Latin | Slovakia |
| Stilnox | Latin | Morocco, Slovakia, South Africa |
| STILNOX CR | Latin | Morocco |
| Zolpidem STADA | Latin | Sweden |
| Ivedal | Latin | South Africa |
| Zolpidem HEXAL | Latin | Sweden |
| Zolpidem Vitabalans | Latin | Sweden |
| Zolpidem Sandoz | Latin | Sweden |
| Adco-Zolpidem Hemitartrate | Latin | South Africa |
| HYPNOGEN | Latin | Slovakia |
| ZOLPIGEN | Latin | Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.