RESTORIL 15 MG — DIN 00604453
TEMAZEPAM : 15 MG · AA PHARMA INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is RESTORIL?
RESTORIL 15 MG contains TEMAZEPAM : 15 MG. It is listed in the Health Canada Drug Product Database under DIN 00604453, held by AA PHARMA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 31-Jan-2018. 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 RESTORIL used for?
RESTORIL (temazepam) is indicated for the symptomatic relief of transient and short-term insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Temazepam cost around the world?
Temazepam is listed on 4 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. Australia publishes a ex-manufacturer; South Africa publishes a single exit price; United Kingdom publishes a hospital. 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 |
|---|---|---|---|---|
| United States | acquisition | 4 | 37 | USD███.██ |
| Australia | ex-manufacturer | 5 | 20 | AUD███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| South Africa | single exit price | 2 | 3 | ZAR███.██ |
63 pack listings across 14 brand entries and 4 price bases, refreshed 08 Sep 2026. Ranges span every Temazepam 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 Temazepam 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.
12 holders have a Canadian DIN containing Temazepam, across 28 DINs, of which 2 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 |
|---|---|---|---|---|
| AA PHARMA INC | 2 | 2 | RESTORIL | Sourceable in Canada |
| APOTEX INC | 4 | 0 | APO-TEMAZEPAM, TEMAZEPAM | No marketed DIN |
| PHARMASCIENCE INC | 4 | 0 | PMS-TEMAZEPAM, PMS-TEMAZEPAM - 15MG, PMS-TEMAZEPAM - 30MG | No marketed DIN |
| COBALT PHARMACEUTICALS COMPANY | 2 | 0 | CO TEMAZEPAM CAPSULES 15MG, CO TEMAZEPAM CAPSULES 30MG | No marketed DIN |
| DOMINION PHARMACAL | 2 | 0 | DOM-TEMAZEPAM | No marketed DIN |
| GENPHARM ULC | 2 | 0 | GEN-TEMAZEPAM 15MG, GEN-TEMAZEPAM 30MG | No marketed DIN |
| NT PHARMA CANADA LTD | 2 | 0 | NTP-TEMAZEPAM | No marketed DIN |
| PENTAPHARM LTD. | 2 | 0 | PENTA-TEMAZEPAM CAPSULES | No marketed DIN |
| PHARMEL INC | 2 | 0 | PHL-TEMAZEPAM | No marketed DIN |
| PRO DOC LIMITEE | 2 | 0 | TEMAZEPAM-15, TEMAZEPAM-30 | No marketed DIN |
| RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | 2 | 0 | RATIO-TEMAZEPAM | No marketed DIN |
| TEVA CANADA LIMITED | 2 | 0 | TEVA-TEMAZEPAM | 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 | 15 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | RESTORIL 15mg: Available in bottles of 100. RESTORIL 30mg: Available in bottles of 100. |
| Storage | null |
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 | Temazepam |
|---|---|
| ATC code | N05CD07 |
| AHFS class | 28:24.08 |
| 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) | 00604453 |
|---|---|
| DIN (unpadded, as printed on some documents) | 604453 |
| Brand name | RESTORIL |
| Generic / active ingredient | TEMAZEPAM : 15 MG |
| Market authorization holder | AA PHARMA INC |
| Health Canada schedule | TARGETED SUBSTANCES (CDSA IV) |
| ATC code | N05CD07 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N05CD |
| Current status | MARKETED |
| Status date | 31-Jan-2018 |
| Original market date | 1980-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
2 of 28 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| RESTORIL | 30 MG | CAPSULE | AA PHARMA INC | MARKETED | 00604461 |
| APO-TEMAZEPAM | 30 MG | CAPSULE | APOTEX INC | DORMANT | 02225972 |
| APO-TEMAZEPAM | 15 MG | CAPSULE | APOTEX INC | DORMANT | 02225964 |
| CO TEMAZEPAM CAPSULES 15MG | 15 MG | CAPSULE | COBALT PHARMACEUTICALS COMPANY | CANCELLED POST MARKET | 02244814 |
| CO TEMAZEPAM CAPSULES 30MG | 30 MG | CAPSULE | COBALT PHARMACEUTICALS COMPANY | CANCELLED POST MARKET | 02244815 |
| DOM-TEMAZEPAM | 15 MG | CAPSULE | DOMINION PHARMACAL | CANCELLED POST MARKET | 02229756 |
| DOM-TEMAZEPAM | 30 MG | CAPSULE | DOMINION PHARMACAL | CANCELLED POST MARKET | 02229758 |
| GEN-TEMAZEPAM 15MG | 15 MG | CAPSULE | GENPHARM ULC | CANCELLED POST MARKET | 02231615 |
| GEN-TEMAZEPAM 30MG | 30 MG | CAPSULE | GENPHARM ULC | CANCELLED POST MARKET | 02231616 |
| NTP-TEMAZEPAM | 15 MG | CAPSULE | NT PHARMA CANADA LTD | CANCELLED PRE MARKET | 02347865 |
2 · Same class — other molecules in ATC N05CD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Midazolam | APO-MIDAZOLAM INJECTABLE 1 MG/ML · APO-MIDAZOLAM INJECTABLE 5 MG/ML · BUCCOLAM · MIDAZOLAM INJECTION · +7 more | 32 | 14 | Yes |
| Temazepam | APO-TEMAZEPAM · CO TEMAZEPAM CAPSULES 15MG · CO TEMAZEPAM CAPSULES 30MG · DOM-TEMAZEPAM · +14 more | 28 | 2 | Yes |
| Flurazepam | BIO-FLURAZEPAM · DALMANE · FLURAZEPAM · FLURAZEPAM 15 · +12 more | 20 | 2 | Yes |
| Nitrazepam | APO-NITRAZEPAM · MOGADON · NITRAZADON · NITRAZEPAM-10 · +2 more | 10 | 2 | Yes |
| Triazolam | ALTI-TRIAZOLAM TAB 0.125MG · ALTI-TRIAZOLAM TAB 0.25MG · HALCION · MYLAN-TRIAZOLAM · +8 more | 16 | 1 | Yes |
| Estazolam | PROSOM TAB 1MG · PROSOM TAB 2MG | 2 | 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 |
| 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 RESTORIL called?
The same molecule, Temazepam, 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 |
|---|---|---|
| APO-Temazepam | Latin | Australia |
| Normison | Latin | Australia |
| Temaze | Latin | Australia |
| TEMAZEPAM-WGR | Latin | Australia |
| Temtabs | Latin | Australia |
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.