Jet lag drug: tasimelteon ("Hetlioz")?
Mar 11, 2014, 10:54 am
#1
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Jet lag drug: tasimelteon ("Hetlioz")?
I've been following the development of tasimelteon (a melatonin receptor agonist) ever since this BBC story appeared in 2008 about its potential use to reduce jet lag.
Almost six years later, the FDA approved the drug -- to treat "Non-24-hour sleep-wake disorder" for the blind, whose symptoms are to me quite similar to those of jet lag. Non-24 is a "complaint of insomnia or excessive sleepiness related to abnormal synchronization between the 24-hour light–dark cycle and the endogenous circadian rhythms of sleep and wake propensity." Jet lag is caused by this same exact lack of synchronization.
The discussion topic is: would an off-label prescription of tasimelteon work for jet lag, as initally promised? I'd like to share my knowledge and get a bit of background (taking it for what it is -- a discussion on a social site), before burdening my doctor with a question about it.
The red flags I see in tasimelteon is that the drug is new (duh!), and that the two trials look incredibly, incredibly tiny to me: just 84 patients in one (6 months), with 26% of the participants dropping out, and 20 on the other (5 months); they were also marred by discord on how to define the results. There is a scathing article about the validity of the trials. The nuances are is beyond my knowledge, but for those interested the entire documentation is available from the FDA site.
However, I am not sure how such small trials could have fleshed out all the potential adverse effects and interactions.
Furthermore, the drug was submitted for approval for the blind only presumably because it requires less scrutiny due to the fact that the FDA wants more drugs for underserved subsegments of the population ("priority review"). This is a red flag, since the jet lag market is probably a magnitude larger than the one for the blind -- so what does the manufacturer know about tasimelteon's broader use?
Should I even bother bringing tasimelteon up with my doctor as a potential way to reduce my fairly frequent jet lag?
PS - the content-free marketing snow job site ("it's great for everything!") is at www.non-24.com
Almost six years later, the FDA approved the drug -- to treat "Non-24-hour sleep-wake disorder" for the blind, whose symptoms are to me quite similar to those of jet lag. Non-24 is a "complaint of insomnia or excessive sleepiness related to abnormal synchronization between the 24-hour light–dark cycle and the endogenous circadian rhythms of sleep and wake propensity." Jet lag is caused by this same exact lack of synchronization.
The discussion topic is: would an off-label prescription of tasimelteon work for jet lag, as initally promised? I'd like to share my knowledge and get a bit of background (taking it for what it is -- a discussion on a social site), before burdening my doctor with a question about it.
The red flags I see in tasimelteon is that the drug is new (duh!), and that the two trials look incredibly, incredibly tiny to me: just 84 patients in one (6 months), with 26% of the participants dropping out, and 20 on the other (5 months); they were also marred by discord on how to define the results. There is a scathing article about the validity of the trials. The nuances are is beyond my knowledge, but for those interested the entire documentation is available from the FDA site.
However, I am not sure how such small trials could have fleshed out all the potential adverse effects and interactions.
Furthermore, the drug was submitted for approval for the blind only presumably because it requires less scrutiny due to the fact that the FDA wants more drugs for underserved subsegments of the population ("priority review"). This is a red flag, since the jet lag market is probably a magnitude larger than the one for the blind -- so what does the manufacturer know about tasimelteon's broader use?
Should I even bother bringing tasimelteon up with my doctor as a potential way to reduce my fairly frequent jet lag?
PS - the content-free marketing snow job site ("it's great for everything!") is at www.non-24.com
Mar 12, 2014, 8:41 am
#3
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Furthermore, the drug was submitted for approval for the blind only
You definately should bring it up with your doctor, as he holds better qualifications than a message board.
Apr 24, 2015, 8:43 pm
#6
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Looks like they're trying to market it in Europe and got the medical review panel there to recommend its approval: http://www.prnewswire.com/news-relea...300071710.html
Apr 24, 2015, 8:47 pm
#7
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Looks like they're trying to market it in Europe and got the medical review panel there to recommend its approval: http://www.prnewswire.com/news-relea...300071710.html