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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by jrbecker76 on September 17, 2009, at 23:49:42
FDA cite's problem with the drug's "benefit-risk" profile....
http://www.fool.com/investing/general/2009/09/17/sleepless-in-sanofi.aspx
Posted by SLS on September 18, 2009, at 11:09:48
In reply to Sleep drug - Ciltyri (Eplivanserin) delayed, posted by jrbecker76 on September 17, 2009, at 23:49:42
> FDA cite's problem with the drug's "benefit-risk" profile....
>
> http://www.fool.com/investing/general/2009/09/17/sleepless-in-sanofi.aspx
Is this drug a true hypnotic or does it improve the neurobiology of the underlying disorder by blocking 5-HT2a receptors? If it is not sedating, it might make an interesting augmenter of antidepressants.
- Scott
Posted by yxibow on September 22, 2009, at 0:35:15
In reply to Re: Sleep drug - Ciltyri (Eplivanserin) delayed » jrbecker76, posted by SLS on September 18, 2009, at 11:09:48
> > FDA cite's problem with the drug's "benefit-risk" profile....
> >
> > http://www.fool.com/investing/general/2009/09/17/sleepless-in-sanofi.aspx
>
>
> Is this drug a true hypnotic or does it improve the neurobiology of the underlying disorder by blocking 5-HT2a receptors? If it is not sedating, it might make an interesting augmenter of antidepressants.Possibly.... but if a drug meant for sleep has no sedating qualities, is it really good for people who have bad insomnia (like myself) ?
-- tidings
Posted by SLS on September 22, 2009, at 5:12:14
In reply to Re: Sleep drug - Ciltyri (Eplivanserin) delayed » SLS, posted by yxibow on September 22, 2009, at 0:35:15
> > > FDA cite's problem with the drug's "benefit-risk" profile....
> > >
> > > http://www.fool.com/investing/general/2009/09/17/sleepless-in-sanofi.aspx
> >
> >
> > Is this drug a true hypnotic or does it improve the neurobiology of the underlying disorder by blocking 5-HT2a receptors? If it is not sedating, it might make an interesting augmenter of antidepressants.
>
> Possibly.... but if a drug meant for sleep has no sedating qualities, is it really good for people who have bad insomnia (like myself) ?
Just guesswork:Two things come to mind. First, is the example of using an antidepressant devoid of direct sedative or anxiolytic properties to treat anxiety disorders. Second, is the circadian rhythm phase advance that agomelatine produces, something that is known to reduce depression.
I am not sure that melatonin has direct hypnotic properties per se as we would assign a benzodiazepine, even though it can help initiate and maintain sleep. I am playing with semantics a bit by using the word "direct". The example here is the person whose ideal time for taking melatonin is in the afternoon. Again, it is a matter of manipulating the circadian rhythms that produces the desired effect.
How would you describe the current popularity of Rozerem (ramelteon), the melatonin receptor agonist? I don't see that it is used very often at all. Perhaps it is being used improperly. With melatonin, timing is everything.
- Scott
Posted by desolationrower on September 22, 2009, at 15:51:10
In reply to Re: Sleep drug - Ciltyri (Eplivanserin) delayed » yxibow, posted by SLS on September 22, 2009, at 5:12:14
5ht2 antagonists imrpove slow wave sleep and other sleep quality measures. so better sleep even if you don't feel glued to the bed
-d/r
Posted by Katgirl on November 14, 2009, at 15:25:16
In reply to Sleep drug - Ciltyri (Eplivanserin) delayed, posted by jrbecker76 on September 17, 2009, at 23:49:42
URGHHHHHHHH! As one who is having sleep issues a delay on this medication is not welcome. HOWEVER, I have a question. When the FDA says they need more information on risk-benefit, does that mean the medication caused some kind of serious health issues in the trial? As someone who is way med sensitive I would hope that these new drugs would be getting "cleaner" instead of the opposite.
Posted by Katgirl on December 7, 2009, at 12:20:24
In reply to Re: Sleep drug - Ciltyri (Eplivanserin) delayed, posted by Katgirl on November 14, 2009, at 15:25:16
I know this drug is delayed in the U.S., but has it been approved in Europe? Just interested.
Very happy about their claims that it doesn't cause next day sedation, bounce back insomnia OR (drum roll please) any withdrawal symptoms.
This is the end of the thread.
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