FAQs about Flumazenil Access
The Hypersomnia Foundation receives many questions about the use of flumazenil in treating IH, including where to find flumazenil. Accordingly, we have put together a list of “Frequently Asked Questions” concerning flumazenil access. These FAQs (and our answers) are set forth below.
1. Has flumazenil been approved by the FDA to treat IH? If not, can my physician still prescribe it to me for my IH symptoms?
Flumazenil is FDA-approved in the U.S. as an intravenous (IV) medication to reverse excessive or prolonged sedation suspected to be caused by benzodiazepines (e.g. Valium, Ambien, etc.). It is not FDA-approved for the treatment of idiopathic hypersomnia (IH) or any other central disorder of hypersomnolence. However, as with any medication approved by the FDA, physicians can choose to prescribe flumazenil “off-label” for indications other than that for which it is approved. This includes use of flumazenil for the treatment of IH and related disorders. Because flumazenil is currently approved in liquid form for IV use, the solid form of flumazenil must be formulated into a transdermal cream or lozenge – for topical or mucosal absorption, respectively – by what is referred to as a compounding pharmacy for use by IH patients.
2. I live outside the U.S., and flumazenil is not approved for any use in my country. Am I out of luck?
If you are not in the U.S., and flumazenil is NOT approved for any use in your country, WEP Clinical may be able to help you with access.
3. Is there any scientific evidence that flumazenil might help my IH symptoms?
The relevant journal articles discussing the use of flumazenil in treating IH and related disorders are as follows:
- Modulation of vigilance in the primary hypersomnias by endogenous enhancement of GABAA receptors (request from a medical library).
- Flumazenil for the Treatment of Refractory Hypersomnolence: Clinical Experience with 153 Patients (free full text).
4. Where can my doctor find flumazenil in a compounded form?
Atlanta Hypersomnia Support maintains a list of compounding pharmacies in the U.S. who compound flumazenil. The Hypersomnia Foundation is not affiliated with this Atlanta support group or any of these pharmacies, and thus cannot speak to the accuracy of this list; however, it is a good place to start. Our 2015 SomnusNooze articles on flumazenil supply may also be helpful.
5. Will my health insurance company pay for my flumazenil?
Many insurance companies will not pay for this medication to treat IH; however, a few will do so, as part of their coverage for compounded medications. You may be able to find further information via support groups, such as Facebook’s Flumazenil for Hypersomnia. Given that there are very few pharmacies in the U.S. that compound flumazenil, we understand from some patients that they have successfully argued with their insurance companies that they must cover the available compounding pharmacies as in-network, on the grounds that the insurance company can provide no in-network options for coverage. However, this is a question that each individual must ask of their own health insurance company, since coverage plans vary greatly.
LEGAL DISCLAIMER: Please note that the information contained in these FAQs is for general informational purposes only. It is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your own personal physician concerning any condition or treatment.