Three manufacturers supplying the U.S. market have flumazenil injection on back order, according to an October 1, 2026 ADA News report, and of the vials listed, only one size from one supplier was reported available as of September 21. Flumazenil is on the Royal College of Dental Surgeons of Ontario (RCDSO) required emergency drug list for every oral and parenteral sedation modality, so Ontario sedation practices should check their stock and expiry dates now rather than waiting for an inspection.
As of October 2026, a reversal agent the RCDSO requires in Ontario sedation emergency kits is harder to buy in the United States. ADA News reported on October 1 that dentists may have trouble accessing flumazenil, a drug used to reverse benzodiazepine overdoses in oral sedation. The report draws on a September 21 drug shortage bulletin from the University of Utah Drug Information Service and the American Society of Health-System Pharmacists (ASHP).
The shortage is a U.S. report. Whether Canadian supply is affected was not confirmed for this article. But Ontario practices have a specific reason to pay attention: the RCDSO sedation standard does not treat flumazenil as optional.
What the ADA Reported
ADA News, citing the September 21 bulletin, listed the status of three manufacturers:
- Baxter: 5 mL and 10 mL vials on back order. Baxter attributed the shortage to manufacturing delays from a third-party supplier and gave no estimated recovery date.
- Fresenius Kabi: 5 mL and 10 mL vials on back order, with 10 mL vials expected in early October and 5 mL vials in mid-October. No reason was given.
- Hikma: 5 mL vials available as of September 21; 10 mL vials on back order, expected mid- to late October. No reason was given.
The ADA also noted that some state laws may require flumazenil to be on hand for these procedures. The ADA points dentists to the sedation guidelines on its anesthesia and sedation webpage.
Why the RCDSO Standard Makes This an Ontario Issue
The RCDSO Standard of Practice Use of Sedation and General Anesthesia in Dental Practice, approved by the College in November 2018 and still the version linked from the College's sedation and anesthesia page, sets the minimum requirements every Ontario dentist must meet. Flumazenil appears by name in the required emergency drug list for each of these settings:
- Offices performing oral minimal sedation
- Offices performing oral moderate sedation
- Offices performing parenteral moderate sedation
- Offices performing deep sedation or general anesthesia
The wording is direct. The standard states that emergency equipment and drugs must be available at all times, and that drugs must be current and stored in a readily identifiable, organized way, such as labelled trays or bags. It is the dentist's responsibility to make sure the office is equipped. A vial that expired during a shortage is not a current drug.
The link to benzodiazepines is just as clear. In the oral minimal sedation section, the standard says that where a patient needs a prescription sedative before arrival, only a benzodiazepine may be prescribed, and its dosing table lists benzodiazepines such as lorazepam, alprazolam, temazepam and oxazepam. If your practice sedates with benzodiazepines, flumazenil is the reversal agent the standard lists for that purpose.
Authorization raises the stakes. Since April 1, 2020, dentists who administer minimal sedation, including oral minimal sedation and nitrous oxide and oxygen sedation, have needed RCDSO authorization, and facilities where it is given are subject to random on-site inspections.
Is Canadian Supply Affected?
EBIKO Dental could not confirm the Canadian status of flumazenil injection for this article. Do not assume either way. A U.S. back order does not automatically mean a Canadian one, and the reverse is also true.
Health Canada states that, for certain drugs, manufacturers are required by law to report anticipated and actual shortages and discontinuations on Drug Shortages Canada (healthproductshortages.ca). That database, not a U.S. bulletin, is the right place to check the products your practice actually buys.
Pro Tip: Search Drug Shortages Canada for "flumazenil" this week, note the DIN of the product in your kit, and ask your pharmacy or medical supplier to confirm in writing whether that exact DIN is on allocation.
What Ontario Sedation Practices Should Check This Week
1. Count what you have, kit by kit
Multi-operatory practices often keep more than one emergency kit. Count flumazenil in each one, along with any backup stock in the dispensary, and record the lot and expiry date of every vial.
2. Look at expiry dates against the shortage window
The ADA report gives recovery estimates from early to late October for two manufacturers and no estimate for the third. If any of your vials expire in the next few months, start sourcing replacements now rather than waiting for the expiry month.
3. Check the Canadian database for your exact product
Use Drug Shortages Canada to check the specific product and DIN you stock. Ask your supplier for written confirmation of availability and expected lead time.
4. Document what you find
Keep a dated note of your kit check, the products and expiry dates found, and the steps taken to restock. Should a random RCDSO facility inspection happen during a supply gap, a record of what you checked and when is far better than an explanation from memory.
Pro Tip: Put one team member in charge of the emergency drug log and set a recurring monthly reminder to review every expiry date. Shortages are easier to handle when you see them coming three months out instead of three days out.
A Reminder on Reversal Agents and Reporting
A shortage is also a good moment to review how the standard treats the use of a reversal agent. The RCDSO standard says that if a reversal agent is administered before discharge criteria have been met, the patient must be monitored beyond the expected duration of action of the reversal agent to guard against re-sedation, and a Tier Two Event must be reported to the RCDSO in writing. The standard also states that the practitioner must not be alone while treating a sedated patient.
Nothing in the ADA report changes these rules. The shortage simply makes it more important that the drug is physically in the kit and in date, and that your team knows the reporting step that follows its use.
If a supply gap leaves your practice unable to meet the emergency drug requirements for a sedation modality, contact the RCDSO directly for guidance before you proceed with sedation appointments. The College, not a supplier or a colleague, is the authority on what your authorization requires.
What Happens Next
Two of the three manufacturers in the ADA report gave October recovery estimates, but estimates in drug shortage bulletins can and do move. EBIKO Dental will continue monitoring this shortage and any Canadian reporting on flumazenil supply. For other updates relevant to Canadian dental practices, visit EBIKO Dental.
Sources
- ADA News: Manufacturers report flumazenil injection shortage (October 1, 2026)
- RCDSO Standard of Practice: Use of Sedation and General Anesthesia in Dental Practice (PDF)
- Health Canada: Drug shortages in Canada
Frequently Asked Questions
Q: Do Ontario dentists have to keep flumazenil for oral sedation?
Yes, under the RCDSO sedation standard. Flumazenil is listed among the emergency drugs an office must be equipped with when performing oral minimal sedation, and it also appears in the lists for oral moderate, parenteral moderate, and deep sedation or general anesthesia.
Q: Is the flumazenil shortage affecting Canada?
That was not confirmed for this article. The ADA reported a U.S. shortage based on a September 21 bulletin. Check Drug Shortages Canada (healthproductshortages.ca), where Health Canada says manufacturers of certain drugs are legally required to report shortages.
Q: When is flumazenil expected to be available again?
According to ADA News, Fresenius Kabi expected 10 mL vials in early October and 5 mL vials in mid-October, Hikma expected 10 mL vials in mid- to late October, and Baxter gave no estimate. Hikma's 5 mL vials were reported available as of September 21.