Trouble Sleeping? – Is Intermezzo the Solution?

You may be feeling soporific after ingesting large quantities of tryptophan containing turkey, but the day before Thanksgiving, the Federal Drug Administration (FDA) announced the approval for zolpidem tartrate sublingual tablets, known as Intermezzo, by Transcept Pharmaceuticals Inc.

This is not a new molecule. It’s actually the same medication as Ambien, but it’s formulated to dissolve under the tongue, and the dose is lower. Ambien is dosed at 5 or 10 mg, but Intermezzo comes in 1.75 mg for women, and 3.5 mg for men. When Ambien is prescribed, it’s generally recommended that it only be taken if one can sleep for 8 hours afterwards, as otherwise one may still be sedated when driving, etc. Because the dose of  Intermezzo is lower, one only needs 4 hours. So if you wake up at 2 am and can’t get back to sleep, it might be a good option.

I have several concerns, however.

Because the name is completely different, there is some risk that patients might inadvertently take Intermezzo and Ambien thereby taking too much, though admittedly it would be at most only a 35% increase over the maximum dose.

My biggest problem with this is cost. Ambien was manufactured by Sanofi-Aventis, but went generic in April 2007 with multiple manufacturers, and is now pretty cheap. Around that time Sanofi-Aventis came out with Ambien CR, packaging zolpidem in a time release pill to make it last longer. It is probably a little better for some people, but I think it basically was a way to extend the patent. In addition, Sonata (zaleplon) works similar to Ambien, but it has a shorter half life. That means it gets out of your system faster. That’s bad if you take it at bed time and tend to awake in the middle of the night, but great if you only want to take it if you wake up in the middle of the night and get can’t back to sleep. That’s just like Intermezzo, only generic.

With Intermezzo you can pay more for less! This is not the first time pharmaceutical companies have done this. Recently Somaxon Pharmaceuticals came out with the sleep medication Silenor. This is doxepin in a 3 or 6 mg pill, and supposedly works better than the higher dose generic pills. At Drugstore.com, 10 mg doxepin costs $28.99 for 90 capsules (note you can’t just split them), or about $10 per month. Silenor is more than ten times the price for about half as much medication.

Transcept Pharmaceuticals, Inc. is also attempting to do the same thing with TO-2061, a low dose form of ondansetron (Zofran) for obsessive-compulsive disorder. Wouldn’t you know it, but ondansetron is generic now.

Author: Daniel Ginsberg, MD, FACP

I'm an internal medicine physician and have avidly applied computers to medicine since 1986, when I wrote my first medically oriented computer programs. So yes, that means I'm at least 35-years-old! View all posts by Daniel Ginsberg, MD, FACP