APO-ZOLPIDEM ODT 5 MG
ZOLPIDEM TARTRATE : 5 MG · DIN 02436159 · APOTEX INC
Health Canada status: MARKETED
What is APO-ZOLPIDEM ODT?
APO-ZOLPIDEM ODT 5 MG contains ZOLPIDEM TARTRATE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02436159, 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 of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings with impaired daytime functioning.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02436159 |
|---|---|
| Brand name | APO-ZOLPIDEM ODT |
| Generic / active ingredient | ZOLPIDEM TARTRATE : 5 MG |
| Manufacturer | APOTEX INC |
| Strength | 5 MG |
| Dosage form | TABLET (ORALLY DISINTEGRATING) |
| Route of administration | SUBLINGUAL |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| ATC code | N05CF02 ZOLPIDEM |
| AHFS class | 28:24.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 13-Feb-2015 |
| Original market date | 2015-02-13 00:00:00 |
How is it administered?
Take once per night immediately before bedtime with 7-8 hours before awakening. Sublingual tablet: place under tongue; do not chew, swallow, or take with water. Max 10 mg/day.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (Section 11 is listed in TOC but content is missing).
How is it supplied?
Blister packs of 30; Bottles of 30, 100, and 500 tablets.
Contraindications
Hypersensitivity to zolpidem; 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; severe withdrawal symptoms; risks from concomitant use with opioids; complex sleep-related behaviours (e.g., sleep-driving); next-day impairment.
What can be used instead?
Other Canadian products sharing ATC code N05CF02 ZOLPIDEM. 12 of 18 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | APOTEX INC | MARKETED | DIN 02434946 |
| JAMP ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | JAMP PHARMA CORPORATION | MARKETED | DIN 02540606 |
| JAMP ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | JAMP PHARMA CORPORATION | MARKETED | DIN 02540592 |
| MINT-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | MINT PHARMACEUTICALS INC | MARKETED | DIN 02472848 |
| MINT-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | MINT PHARMACEUTICALS INC | MARKETED | DIN 02472821 |
| PMS-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | PHARMASCIENCE INC | MARKETED | DIN 02436183 |
| PMS-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | PHARMASCIENCE INC | MARKETED | DIN 02436175 |
| PRO-ZOLPIDEM ODT | 10 MG | TABLET (ORALLY DISINTEGRATING) | PRO DOC LIMITEE | MARKETED | DIN 02537354 |
| PRO-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | PRO DOC LIMITEE | MARKETED | DIN 02537346 |
| SUBLINOX | 10 MG | TABLET (ORALLY DISINTEGRATING) | BAUSCH HEALTH, CANADA INC. | MARKETED | DIN 02370433 |
Who else supplies ZOLPIDEM worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ZOLPIDEM appears in 1425 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.