IVADAL 5 MG
ZOLPIDEM TARTRATE : 5 MG · DIN 02205971 · SANOFI-AVENTIS CANADA INC
Health Canada status: CANCELLED PRE MARKET
What is IVADAL?
IVADAL 5 MG contains ZOLPIDEM TARTRATE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02205971, held by SANOFI-AVENTIS CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled pre market, status dated 17-Jul-2017. 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 IVADAL used for?
Short-term treatment and symptomatic relief of insomnia (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 | 02205971 |
|---|---|
| Brand name | IVADAL |
| Generic / active ingredient | ZOLPIDEM TARTRATE : 5 MG |
| Manufacturer | SANOFI-AVENTIS CANADA INC |
| Strength | 5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| ATC code | N05CF02 ZOLPIDEM |
| AHFS class | 28:24.92 |
| Biosimilar | No |
| Health Canada status | CANCELLED PRE MARKET |
| Status date | 17-Jul-2017 |
How is it administered?
Adults: 10 mg immediately before bedtime. Elderly/Hepatic Impairment: 5 mg. Use should not exceed 7-10 days. Do not take with or immediately after a meal.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in provided text.
How is it supplied?
Not specified in provided text (mentions prescriptions should not exceed 1-month supply).
Contraindications
Hypersensitivity to zolpidem; severe hepatic insufficiency; acute and/or severe impairment of respiratory function (e.g., significant sleep apnea syndrome).
Warnings and precautions
Risk of complex sleep-related behaviors (sleep-driving); severe anaphylactic reactions; anterograde amnesia; potential for dependence/abuse; caution in depression/suicide risk.
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.