SUBLINOX 10 MG
ZOLPIDEM TARTRATE : 10 MG · DIN 02370433 · BAUSCH HEALTH, CANADA INC.
Health Canada status: MARKETED
What is SUBLINOX?
SUBLINOX 10 MG contains ZOLPIDEM TARTRATE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02370433, held by BAUSCH HEALTH, CANADA INC., supplied as TABLET (ORALLY DISINTEGRATING) for SUBLINGUAL administration. Health Canada currently lists it as marketed, status dated 05-Jul-2019. 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 SUBLINOX 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.
Product details and regulatory record
| DIN | 02370433 |
|---|---|
| Brand name | SUBLINOX |
| Generic / active ingredient | ZOLPIDEM TARTRATE : 10 MG |
| Manufacturer | BAUSCH HEALTH, CANADA INC. |
| Strength | 10 MG |
| Dosage form | TABLET (ORALLY DISINTEGRATING) |
| Route of administration | SUBLINGUAL |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| ATC code | N05CF02 ZOLPIDEM |
| AHFS class | 84:80.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 05-Jul-2019 |
| Original market date | 2012-03-01 00:00:00 |
How is it administered?
Take once per night immediately before bedtime with 7-8 hours before awakening. Initial dose: 5 mg for women, 5 or 10 mg for men. Max 10 mg/day. Place under tongue; do not chew/swallow.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in the provided text (refer to section 11 of full monograph).
How is it supplied?
Blister packs (aluminum/aluminum) of 30 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 if stopped abruptly; risks from concomitant use with opioids; complex sleep-related behaviours (e.g., sleep-driving).
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 |
| APO-ZOLPIDEM ODT | 5 MG | TABLET (ORALLY DISINTEGRATING) | APOTEX INC | MARKETED | DIN 02436159 |
| 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 |
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.