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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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ZOPICLONE

All products: not a benefit

Other products in the same Health Canada class (N05C, N05CF) — coverage varies; not interchangeable

  • Eszopiclone (Lunesta): not a benefit
  • Zolpidem (Sublinox): not a benefit
  • Flurazepam (Dalmane): general benefit, Not a benefit
  • Nitrazepam (Mogadon): general benefit
  • Temazepam (Restoril): general benefit
  • Triazolam (Halcion): general benefit, Not a benefit

1 more in the class list below

M-Zopiclone · DIN 02467968 · 7.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Zopiclone Brand(s): Imovane + generic brands DOSAGE FORM/ STRENGTH: 5 mg, 7.5 mg tablet For the treatment of insomnia as a single hypnotic agent in patients who meet the following criteria; • Have failed at least two benzodiazepines; OR • Have failed or experienced intolerance to at least one benzodiazepine and one other hypnotic (i.e., amitriptyline, trazodone, etc) Duration of Approval: 2 Years For the treatment of insomnia if patient has an identified psychiatric diagnosis. Renewals will be considered in patients who are responding to therapy AND who continues to require therapy AND who are using zopiclone as a single agent. Duration of Approval: 2 Years 160 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 160, record 93, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)
1 brand, same coverage
M-Zopiclone · DIN 02467968 Manufacturer: Mantra Pharma Inc.; listing date 2021-10-29 Health Canada: Marketed since 2018-04-16 · brand M-ZOPICLONE · ATC N05CF01 ZOPICLONE · form Tablet · route Oral · ingredients ZOPICLONE 7.5 MG · company Mantra pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

M-Zopiclone: Formulary list price $0.4685/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.4685 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95632 · Verify on the e-Formulary ↗ (DIN 02467968)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02467968). DIN 02467968: M-Zopiclone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 282400179; group id 531; item number 1437; lccId None; manufacturer id MAT Source form: Tab; strength: 7.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $0.4685; ministry $0.4685 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02467968 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95632
Interchangeable products
AG-Zopiclone · DIN 02475847 · $0.4685 Apo-Zopiclone · DIN 02218313 · $0.4685 Co Zopiclone · DIN 02271958 · $0.4685 Imovane · DIN 01926799 · not recorded Jamp Zopiclone · DIN 02549301 · $0.4685 Jamp-Zopiclone · DIN 02356805 · $0.4685 Jamp-Zopiclone Tablets · DIN 02406977 · $0.4685 Mar-Zopiclone · DIN 02386798 · $0.4685 Mint-Zopiclone · DIN 02391724 · $0.4685 NRA-Zopiclone · DIN 02477386 · $0.4685 PMS-Zopiclone · DIN 02240606 · $0.4685 Ran-Zopiclone · DIN 02267926 · $0.4685 Ratio-Zopiclone · DIN 02242481 · $0.4685 Riva-Zopiclone · DIN 02278049 · $0.4685 Sandoz Zopiclone Tablet · DIN 02008203 · $0.4685 Septa-Zopiclone · DIN 02386917 · $0.4685 Zopiclone · DIN 02282445 · $0.4685 Zopiclone · DIN 02385848 · $0.4685
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02467968
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (28:24 Sedatives and Hypnotics) and how they are covered

Matched class: 28:24 Sedatives and Hypnotics

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: NITRAZEPAM, PHENOBARBITAL, TEMAZEPAM Some products covered without a code (check the product listing): BUSPIRONE HYDROCHLORIDE, FLURAZEPAM, METHOTRIMEPRAZINE, TRIAZOLAM 28:24 Sedatives and Hypnotics

ESZOPICLONE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 1mg, 2mg, 3mg · Tab

ZOLPIDEM TARTRATE

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 10mg · SL Tab

FLURAZEPAM

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 15mg, 30mg · Cap

NITRAZEPAM

· 2 products · General benefit · strengths: 5mg, 10mg · Tab

TEMAZEPAM

· 2 products · General benefit · strengths: 15mg, 30mg · Cap

TRIAZOLAM

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 0.125mg, 0.25mg · Tab

MIDAZOLAM

· 3 products · Listed, not a benefit (1), Limited Use, codes 495, 496 (2) · strengths: 5mg/mL · Inj Sol (with Preservative)

BUSPIRONE HYDROCHLORIDE

· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 10mg · Tab

METHOTRIMEPRAZINE

· 9 products · General benefit (5), Listed, not a benefit (4) · strengths: 25mg/mL, 2mg, 5mg, 25mg, 50mg · Inj Sol-1mL Pk, Tab

PHENOBARBITAL

· 5 products · General benefit · strengths: 5mg/mL, 15mg, 30mg, 60mg, 100mg · Oral Elixir, Tab

LORAZEPAM

· 9 products · Listed, not a benefit (1), Limited Use, codes 481 (2), Off-Formulary Interchangeable, not an ODB benefit (6) · strengths: 4mg/mL, 0.5mg, 1mg, 2mg · Inj Sol (with preservative), SL Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:24
Full class listing Related classes: 28:08 Analgesics, 28:10 Opiate Antagonists, 28:12 Anticonvulsants, 28:16 Psychotherapeutic Agents, 28:20 C.N.S. Stimulants, 28:36 Antiparkinsonian Agents, 28:92 Miscellaneous Central Nervous System Drugs Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 Indications IMOVANE (zopiclone) is indicated for short-term (usually not exceeding 7-10 days) use for: • treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep • frequent nocturnal awakenings and/or early morning awakenings where disturbed sleep results in impaired daytime functioning (see 4.1 Dosing Considerations). 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (≥65 years of age):Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness (see 4.1 Dosing Considerations, 4.2 Recommended Dose and Dosage Adjustments, 7.1.4 Geriatrics). Long-term use of IMOVANE should be avoided, including in geriatric patients. Enhanced monitoring is recommended (see 7 Warnings and Precautions, Falls and Fractures; 4.1 Dosing Considerations). https://pdf.hres.ca/dpd_pm/00082951.PDF PM date: not printed or not captured Source product: IMOVANE; DIN 01926799; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Zopiclone (Imovane + generic brands)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of insomnia as a single hypnotic agent in patients who meet the following criteria;

Ministry criteria corpus 2025-01-01; page 160

Zopiclone Brand(s): Imovane + generic brands DOSAGE FORM/ STRENGTH: 5 mg, 7.5 mg tablet
For the treatment of insomnia as a single hypnotic agent in patients who meet the following criteria;
• Have failed at least two benzodiazepines; OR
• Have failed or experienced intolerance to at least one benzodiazepine and one other hypnotic (i.e., amitriptyline, trazodone, etc)
Duration of Approval: 2 Years
For the treatment of insomnia if patient has an identified psychiatric diagnosis. Renewals will be considered in patients who are responding to therapy AND who continues to require therapy AND who are using zopiclone as a single agent.
Duration of Approval: 2 Years
160

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.