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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

PMS-Zopiclone · DIN 02458543 · 3.75mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Imovane + generic brands; DOSAGE FORM/ STRENGTH: 5 mg, 7.5 mg tablet — not this product; no criteria on record for this product in this block. 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
1 brand, same coverage
PMS-Zopiclone · DIN 02458543 Manufacturer: Pharmascience Inc.; listing date 2025-07-31 Health Canada: Marketed since 2017-01-01 · brand PMS-ZOPICLONE · ATC N05CF01 ZOPICLONE · form Tablet · route Oral · ingredients ZOPICLONE 3.75 MG · company Pharmascience inc · schedule Prescription
Check this DIN again · Health Canada product record

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=94567 · Verify on the e-Formulary ↗ (DIN 02458543)

Source record
DIN 02458543: PMS-Zopiclone Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 282400243; group id 531; item number 1435; lccId None; manufacturer id PMS Source form: Tab; strength: 3.75mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $0.2343; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02458543 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94567
Interchangeable products
Imovane · DIN 02125285 · not recorded Jamp Zopiclone · DIN 02549271 · not recorded
Shortage status: not checked (no credentials)
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.

Other review policies

For PMS-Zopiclone: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026