Thursday, February 20, 2014

Suvorexant -- Latest Comments, And Replies -- On My Other Back-Up Site: Timing Of Any FDA Approval

Over at my archive/back-up site, a long running, if sporatic, series of comments ask about progess on suvorexant, the Merck sleep aid candidate.

Here is my contribution to that:

. . . .Mr. Leder --

Two notes, as the author of this site. (1) Suvorexant isn't likely to gain approval until late 2014 at the earliest, as FDA has asked for data to support the theory that a very low dose (10 mg) would have a safe (no lasting morning impairment), yet therapeutic (soparific) effect. FDA has done so because it is concerned about the persistent morning impairment seen at higher doses, in the clinical trials. [Just as seen in other prescription sleep aids already on market in the US.]

(2) Last week, the US DEA listed a rule, for comment, which will become final -- and thus be the law, on suvorexant -- in 45 days. That rule makes suvorexant a schedule IV controlled substance. That means the DEA sees a very high potential for abuse of this drug, when it reaches market. Recreational drug users will try mightily to get a hold of 'scrips for the drug. So, it is going to be pretty difficult to get a 'scrip for it. Just so you are prepared for how things may shake out in late 2014, or early 2015. You -- and your treating medical doctor, or psychologist -- will be required to jump through some extra hoops in order to be able to get it to you -- and so that you may lawfully take it.

I am sorry, but that is how it is going to be.

I wish you the best. Sleeplessness can be agony. That I do understand.


[Latest Commenter; some intervening comments redacted (for clarity of story line).:]

Submitted on 2014/02/20 at 1:54 am

Dear Ms. Wheeler,

just read ur insightful comments. I am suffering terribly from insomnia and, despite every possible " remedy", the problem has worsened. I'm praying that Suvorexant is the answer to our problem. Pls let me know the status of FDA approval -- if u are aware of the possible go ahead.

Most appreciatively,

-- Robert Leder. . . .

[Original comment:]

I have been following the approval process ever since I read about suvorexant. I am a 67 year old woman with no serious health issues, a cyclist and a gym enthusiast. However, after having suffered acute insomnia for over 20 years I am very eager to try this new medication. When I first read about it, I was very excited because it seemed as though it was being developed just for me.

I have been a patient at Stanford University in their sleep study program; ranked as one of the top sleep centers in the country. After three years of following their protocols my sleep did not improve at all and I was told that I had no underlying mental or physical issues which led me to believe insomnia was caused by some kind of chemical inbalance.

To read that this medication is going to affect my “awakeness” was such a revelation. That is what my insomnia has always felt like. I am always wakeful which makes it very hard to get to sleep and to stay asleep. Last night I was feeling fine, did not overeat, did not have any alcohol, and I didn’t sleep one minute.

My life and that of my family’s is so impacted by my condition. I don’t know how much damage it might have done to my overall health. I have tried many prescription pills which always loose their efficacy. I also have tried meditation, therapy, biofeedback and acupuncture. All these years later I am actually worse.

Keep me posted as to when this drug might be avilable.

-- Jacquelyn Wheeler

October 14, 2013 at 5:02 pm. . . .

We will keep you informed.

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