Vanda's New Insomnia Drug
In the recent Washington Post Article, "Test of Insomnia Drug Bolsters Vanda's Plan", I saw news on a new insomnia drug sending a stock sky high.
In the wonderful world of sleep medicine, this is old news. We have seen these claims time and time again, only to never actually pan out in the final phases of clinical trials. A great example of this was the compound Indeplon, created by smaller house Neurocrine and goliath Pfizer. When the trials looked fantastic (which they did), the FDA didn't give it a go. And of course the stock plummeted.
The reasoning behind the FDA non-approval of a particular dosage (which was a needed marketing point) was that they did not have time to work their way through all of the data. Amazing. I have patients who could have benefited from this medication, but the FDA did not have the time or the inclination to figure it out.
Am I happy about the idea of a new medication coming on the market that could directly help with Circadian Rhythm disorders? Sure. My first question however would be "Can it be used in teenagers?"
"Why?", you ask?
Simple -- because most teenagers suffer from a mild form of phase delay -- a circadian rhythm disorder that makes kids want to stay up late and sleep in (although drinking Red Bull by the case will do this as well!).
Next, I would ask about its effects in the elderly. Again, why? Because we see a HUGE number of those age 65 and older going to bed at 6:30 and getting up at 3:30, and wondering what is wrong with them. I often prescribe what I call "The Jay Leno Treatment". I ask them to stay up and watch Jay's Monologue and then turn out the light. This usually pushes them through til morning.
As for shift workers, would this help? Absolutely. Assuming we see that the drug works, what I would want to understand is, if this makes you sleep 46 minutes longer and 28 minutes sooner, then why would someone think it affects the internal biological clock?
It seems to be stretching sleep at both ends -- more of an insomnia need. Traditional circadian rhythms are the correct total sleep time, just at the wrong time of night or morning.
Again, confusing. I like that there are more medications and companies that are working on insomnia because I personally do not think that there are enough options to help people -- so that part is great. But would I buy the stock? I'll wait to see the clinical trials.
-- Dr. Mike
Related Topics:
Technorati Tags: circadian rhythm disorder, insomnia
In the wonderful world of sleep medicine, this is old news. We have seen these claims time and time again, only to never actually pan out in the final phases of clinical trials. A great example of this was the compound Indeplon, created by smaller house Neurocrine and goliath Pfizer. When the trials looked fantastic (which they did), the FDA didn't give it a go. And of course the stock plummeted.
The reasoning behind the FDA non-approval of a particular dosage (which was a needed marketing point) was that they did not have time to work their way through all of the data. Amazing. I have patients who could have benefited from this medication, but the FDA did not have the time or the inclination to figure it out.
Am I happy about the idea of a new medication coming on the market that could directly help with Circadian Rhythm disorders? Sure. My first question however would be "Can it be used in teenagers?"
"Why?", you ask?
Simple -- because most teenagers suffer from a mild form of phase delay -- a circadian rhythm disorder that makes kids want to stay up late and sleep in (although drinking Red Bull by the case will do this as well!).
Next, I would ask about its effects in the elderly. Again, why? Because we see a HUGE number of those age 65 and older going to bed at 6:30 and getting up at 3:30, and wondering what is wrong with them. I often prescribe what I call "The Jay Leno Treatment". I ask them to stay up and watch Jay's Monologue and then turn out the light. This usually pushes them through til morning.
As for shift workers, would this help? Absolutely. Assuming we see that the drug works, what I would want to understand is, if this makes you sleep 46 minutes longer and 28 minutes sooner, then why would someone think it affects the internal biological clock?
It seems to be stretching sleep at both ends -- more of an insomnia need. Traditional circadian rhythms are the correct total sleep time, just at the wrong time of night or morning.
Again, confusing. I like that there are more medications and companies that are working on insomnia because I personally do not think that there are enough options to help people -- so that part is great. But would I buy the stock? I'll wait to see the clinical trials.
-- Dr. Mike
Related Topics:
- Bring Me Your Tired and Sleepless: Tips to Getting a Good Night's Sleep
, - The Toll of Sleep Loss in America
Technorati Tags: circadian rhythm disorder, insomnia
0 Comments:
Post a Comment