The FDA just approved Tonmeyer for fibromyalgia, though you might know it is cyclobenzaprine or flexoril.

What you may not know is that it carries three serious risks for your patients and your license.

Welcome to the Carlet Psychiatry Podcast, keeping psychiatry honest since 2003.

I'm Chris Akin, the editor-in-chief of the Carlat's Psychiatry Report.

And I'm Kelly Newsom, a psychiatric MP and a dedicated reader of every issue.

There are three FDA-approved medications for fibromyalgia, And the FDA just added a fourth. All of them have

psychiatric risks and benefits. And today we'll cover a new one. Cyclobenzaprine, which was just

approved as a sublingal form, branded Tonmaier. Like we covered in our recent ketamine podcast,

this is a secondary approval. New form, new use, new brand name.

In terms of symptoms, it's an important advance for patients, improving sleep and physical pain.

But it carries three risks you need to know about.

There are overdose deaths when combined with benzos or opioids, and the DEA is in hot pursuit

of clinicians who prescribe those three together.

It can cause mania and psychosis, and in the elderly it may cause more trouble than it's worth.

First, let's review past fibromyalgia approvals.

It started with pre-gabalin Lyrica in 2007.

Pre-Gabalin may lack FDA approvals in psychiatry, but it is useful there. It's actually approved in Europe for generalized anxiety disorder, and I think it should be

recommended there here in the U.S. as well.

Pre-Gabalin is more effective than SSRIs and SNRIs in anxiety disorders,

judging by its effect size, and it has better evidence than its gabapentinoid cousin,

gabapentin, in anxiety, especially in GAD and social anxiety disorder, where pre-gabalin is dosed at 300 to 600 milligrams a day, usually all at night.

With its ability to deepen sleep quality, pre-gabalin is preferred in fibromyalgia for patients with sleep problems and pain.

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