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, 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.

Penny Wise, Pound Foolish

A patient of mine has been on cyclobenzaprine, a muscle relaxer, intermittently for over a year. Now her insurance, a Humana, Medicare plan, said they will no longer cover it. I pointed out to them that the medication is generic and at Costco one could purchase 100 pills for $9.93 without insurance. That would be enough to last her over 3 months. The Costco price for tizanidine they suggested I switch her to costs even more. They told me to check their website for what they cover, which I did. It said cyclobenzaprine is covered, though on some of their plans it requires prior authorization, which is what I tried to obtain. Besides the risk of switching a medication to something new, Humana wasted the time of my nurse and I for what would be a minuscule, if any savings. They would not budge other than saying she had to first try and fail tizanidine.

I understand the need to control costs, but forcing doctors to change from one cheap medication to another cheap one is not the way to do it. It doesn’t save significant amount of money, and it frustrates their customers (the patients) and their physicians.

Insurance companies such as Humana place no value on physicians time. I hope other physicians join me contesting such things from time to time. Don’t just accept the first no. Make them deal with extra phone calls and faxes when they are unreasonable. If enough of us protested, I think we could force them to change their ways. Occupy Medical Insurance Companies Movement, anyone?

Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.