Talk:Tasimelteon

tested in nocturnal animals?

I just added some info about this new drug and the experiments with mice, rats, and bunnies. Aren't mice and rats nocturnal? And how does that affect the testing on a human bio-rhythm substance? This article could use some non-advertising non-promotional references. They are advertising heavy on tv right now, which could bring readers to the topic and I don't think that WP wants to give one-sided info which only serves to promote uninformed human experimentation with a new drug.24.0.133.234 (talk) 04:58, 7 May 2014 (UTC)

I've removed your paragraph, but left a reference-URL in external links. Info about testing on rodents is not needed in this article. --Hordaland (talk) 06:37, 7 May 2014 (UTC)

I undid your blanking of the rodent info. Yes it is needed. This drug is being marketed to the US public very heavily and they deserve to know why it was given a category "C" label. No reason to leave the info. out of the article.24.0.133.234 (talk) 15:24, 7 May 2014 (UTC)

This article obviously needs a lot of work, compare Melatonin receptor agonist and Ramelteon. Some details about rodent trials may be appropriate in a history section, in connection with Category C, when the article is well-developed. It seems out-of-place now.

However, the FDA's pregnancy category C could well be mentioned & defined already now. --Hordaland (talk) 02:33, 8 May 2014 (UTC)

Extensive rework

First, and mainly, a note about myself.

I'm presently free-running with a 25h30m body clock. My circadian rhythm disorder began thirty years ago. For a couple of years I was able to reduce my circadian period to circa 24h15m by taking melatonin mid-day. The dose required to almost achieve a 24-hour period wiped me out for about four hours in the evening. My life consisted of work, sitting on the couch struggling to stay awake, finally heading to bed for excellent sleep, followed by waking the next morning in an excellent mood, until my drift accumulated to where I had to free-run for a few days and re-synchronize. Eventually my digestive system couldn't handle a sufficient dose (drift increase to 30 minutes per day and sleep was constantly interrupted by stomach pains), and it was only a halfway satisfactory lifestyle anyway, so I went back to free-running.

I happen to be a sighted individual with a longer period than most blind individuals. My present goal is to synchronize my life around a three-week schedule where I have twenty waking periods over twenty-one days (roughly a 25h10m body clock). I'm seeking for a treatment option that will reduce my period by about 20 minutes per days with a minimum of side effects. I believe agomelatine is available in Canada, so I'll be pestering my physician to give this a go sometime soon.

I've subsequently learned that some of my sluggishness taking melatonin was due to a reduction in core body temperature. I was never able to figure out if the effectiveness of the melatonin was due to the sluggishness (the reduction in core body temperature could be causal to the period shift) or whether I could somehow abate the sluggishness with exercise or a stimulant. My sleep records show that less sluggishness tended to correlate with less effectiveness (I tried many things, including coffee later in the day, etc.)

Because I'm fairly close to the subject I've mainly limited myself to strongly sourced statements. This can be annoying. I wanted to just write "Tasimelteon is not yet available outside of the US" yet despite encountering a class five Google vacuum in dredging up counter-examples, there's apparently no source that flatly states this (the vendor certainly doesn't). Hence status "none" from a stiff UK database.

This article could use a great deal more work, but because of my situation, I'd prefer to play second fiddle. If anyone comes along and wants to step into the first fiddle breech, by all means wake me. — MaxEnt 16:55, 15 May 2014 (UTC)

Thanks for posting your background I guess-it certainly is an interesting topic. I'm not so sure that this crap I mean medicine is actually available in the US even-though it is being advertised? I tried to do a price check and couldn't find it being available. I always hate when a drug company advertises a "condition"(ads for non-24 in completely blind people)---but then direct consumers to visit their website-(which is owned by the drug company)--to learn more about this condition and "new treatment".24.0.133.234 (talk) 22:57, 27 May 2014 (UTC)

FDA approval

There have been a couple of reversions in this section, and I’ll try to give an explanation here, in case the matter continues to pop up.

This section previously read:

• In May 2013 Vanda Pharmaceuticals submitted a New Drug Application to the Food and Drug Administration for tasimelteon for the treatment of non-24-hour sleep–wake disorder in totally blind people. It was approved by the FDA on January 31, 2014 under the brand name Hetlioz.

On July 3, this sentence was added to the above:

• However according to Public Citizen they erroneously approved it for use for sighted as well as blind people

That edit was reverted the same day.

On July 4, the original poster of the edit added the information again, reworded:

• However according to Public Citizen the FDA erroneously allowed it to be labelled without stating that is only approved for use by totally blind people

As our Wikipedia article on Non-24 explains, Non-24 in the blind and in the sighted do not have the same causes. Non-24 in blind patients is easily explained by the "absence of photic input to the circadian clock.", "the suprachiasmatic nucleus (SCN), located in the hypothalamus, is not cued each day to synchronize the circadian rhythm to the 24-hour social day…"

The same article states that Non-24 "can also occur in sighted people for reasons that are not well understood.", "the problem appears to be neurological". Several likely or possible causes are explained. So it seems that the FDA’s error has been in approving Tasimelteon (Hetlioz) for use in the sighted disorder which has different causes than the one in the blind population. There have been no trials with sighted Non-24 patients.

(IMO it is unfortunate that both disorders bear the same name, as they clearly have different causes!)

Thus, at least in my opinion, the addition of Public Citizen’s issue should be included here. I will let this rest for a few days. If there are no comments nor changes to the section, I’ll come back to do at least minor fixes, such as wikilinking Public Citizen and fixing format.

REFERENCES

 Done --Hordaland (talk) 18:18, 8 July 2015 (UTC)