Indirectly, yes, but an "endorsement" nonetheless. The agency has approved an old sleep medication in a new form — the form I've been recommending to patients for more than a decade.
In late November, the FDA announced approval for a "new" insomnia drug called Intermezzo. This is Ambien (zolpidem) in a low-dose, sublingual form, for people who wake up during the middle of the night and have trouble falling back asleep — a common problem for people with CFS and fibromyalgia.
Basically, this "new" drug is what I have been telling patients to do for more than a decade if they wake during the night, which is take 1/3 to 1/2 of a 5 mg tab of Ambien (or in some with CFS/FMS, as much as 5 mg). Bite the pill and let it dissolve under your tongue as you go back to sleep.
The difference between that therapy and the "new" drug? The new form of Ambien is $2-3 dollars per pill instead of just 10 cents for the same amount as a generic!
I suspect this is simply a way for the drug company to continue to market a form of Ambien that is still under patent protection (i.e., expensive) now that low-cost, generic Ambien is available.
The key to using sublingual (under the tongue) Ambien during the night is to make sure you don't take an amount that causes next-day sedation and driving problems. Here's the right dose (and the equivalent of the new medication):
- For women, 1/3 of a 5 mg Ambien tab, or 1.75 mg.
- For men, 2/3 of a tab, or 3.5 mg.
I recommend that if you plan to use it, keep it by your bedside in case you wake during the night. Just be sure not to take it if you have less than 4 hours before you plan to drive anywhere.
Jacob Teitelbaum, M.D. is one of the world's leading integrative medical authorities on fibromyalgia and chronic fatigue. He is the lead author of eight research studies on their effective treatments, and has published numerous health & wellness books, including the bestseller on fibromyalgia From Fatigued to Fantastic! and The Fatigue and Fibromyalgia Solution. Dr. Teitelbaum is one of the most frequently quoted fibromyalgia experts in the world and appears often as a guest on news and talk shows nationwide including Good Morning America, The Dr. Oz Show, Oprah & Friends, CNN, and Fox News Health.