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(Reuters)   FDA objects to new sleep drug because it "impairs driving", presumably by making you sleepy   (reuters.com) divider line 76
    More: Fail, FDA, Merck, Stanford University School of Medicine, insomnias, Suicidal Thoughts, objects, ISI, Ambien  
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3569 clicks; posted to Main » on 23 May 2013 at 1:52 AM (1 year ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2013-05-22 11:50:11 PM  
Headline and green light fail. Did you even RTFA?
 
2013-05-22 11:50:41 PM  
Drifting off from time to time is the only thing that keeps my morning commutes interesting.
 
2013-05-22 11:57:01 PM  

bighoss: Headline and green light fail. Did you even RTFA?


From the article: Speaking for the FDA, Dr. Ronald Farkas noted cases in which patients had reported sleep paralysis and terrifying hallucinations. He also expressed the agency's concern about the drug's impact on driving.

While a 'concern' is technically not an 'objection', subby's headline still seems to follow the gist of the sentence.

/not subby
 
2013-05-23 12:06:03 AM  
The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.


Well, I guess they're right...
 
2013-05-23 12:06:12 AM  
That's amazzz-zzzzzzzz-zzzzzzz
 
2013-05-23 12:08:31 AM  
I believe subby's attempted joke was meant to imply that the impaired driving from sleepiness concern was due to taking the drug as prescribed at night, not impaired driving the next day due to grogginess as the article states. I could be wrong, but the joke and green light still suck. Just my opinion, I welcome yours.
 
2013-05-23 12:20:36 AM  

scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...


Why does it seem like every other drug these days causes suicidal thoughts?
 
2013-05-23 12:23:01 AM  

fusillade762: Why does it seem like every other drug these days causes suicidal thoughts?


I think life in general can cause suicidal thoughts -- but only for those who are paying attention.

/not saying I encourage acting on those thoughts ...
 
2013-05-23 12:26:37 AM  
Still, the panel voted 13 to 3, with one abstention, that the drug could be used safely at the 15 and 20 milligram doses. It voted 8-7, with two abstentions, that the drug is not safe at 30 and 40 milligrams.

They needed to sleep on it.
 
2013-05-23 12:35:36 AM  

fusillade762: scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...

Why does it seem like every other drug these days causes suicidal thoughts?


Maybe it's not the drugs?
 
2013-05-23 12:50:46 AM  
24.media.tumblr.com
 
2013-05-23 01:56:07 AM  
Man if I remember how I got to where I was going or how I got home it would probably be a bad day.
/Just sayin'
 
2013-05-23 01:59:56 AM  
"...a new class of sedatives that block chemicals in the brain called orexins..."

clccharter.org
 
2013-05-23 02:10:29 AM  
But sleeping while you drive would be a great time saver!
 
2013-05-23 02:11:25 AM  
ambienwalrussays.com

Ambien Walrus is about to get new competition.

And the best cure for insomnia in 95% of cases is to remove things, not add drugs. Caffiene, nicotine, alcohol, TV, internet, Fox News. Heck, we should probably get rid of room filling lighting.
 
2013-05-23 02:11:50 AM  
Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?
 
2013-05-23 02:13:58 AM  

ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?


Dude that is a great hangover cure lemme tell ya.
: )
 
2013-05-23 02:14:28 AM  
 terrifying hallucinations

Sign me up for 2 of those.
 
2013-05-23 02:16:48 AM  

tinfoil-hat maggie: ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?

Dude that is a great hangover cure lemme tell ya.
: )


It makes your liver hurt, but it sure takes the edge off a bad day.
 
2013-05-23 02:17:59 AM  
so merck wants to get in on the prescription sleep aid game.

i see these lunesta commercials constantly. let's check out the side effects:

LUNESTA acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Do not take LUNESTA if you are allergic to anything in it. LUNESTA should not be taken together with alcohol. Until you know how you will react to LUNESTA, you should not drive or operate machinery. Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. Walking, eating, driving or engaging in other activities while asleep without remembering it the next day have been reported. Other abnormal behaviors include aggressiveness, agitation, hallucinations and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your doctor if you experience these or any effects or reactions that concern you. LUNESTA, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness and dizziness.

i'd rather just have a few beers before bed.
 
2013-05-23 02:23:22 AM  

ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?


Heh. Getting a kick...

/...and a little woozy.

//Um...does anybody know if it's normal for a human liver to make a sound. Because, I think mine just made a sound.

///...a very, very bad sound.
 
2013-05-23 02:23:48 AM  

fusillade762: scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...

Why does it seem like every other drug these days causes suicidal thoughts?


I hear they got a pill for that now, but it causes impotence, which...
 
2013-05-23 02:25:29 AM  

ecmoRandomNumbers: tinfoil-hat maggie: ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?

Dude that is a great hangover cure lemme tell ya.
: )

It makes your liver hurt, but it sure takes the edge off a bad day.


My liver can live through anything, anything I tell ya, kidneys not so much.
 
2013-05-23 02:27:28 AM  
 
2013-05-23 02:29:39 AM  

Bumblefark: ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?

Heh. Getting a kick...

/...and a little woozy.

//Um...does anybody know if it's normal for a human liver to make a sound. Because, I think mine just made a sound.

///...a very, very bad sound.


Did you just promise to give up drinking? That was probably a shout of joy.
 
2013-05-23 02:30:25 AM  
fta
Speaking for the FDA, Dr. Ronald Farkas noted cases in which patients had reported sleep paralysis and terrifying hallucinations .

Oh, sign.me.up.
 
2013-05-23 02:31:07 AM  
I think this is  the real takeaway:

"Like its predecessors, suvorexant's marginal benefit in extending overnight sleep time by a few minutes is achieved at the expense of prolonged, next-day drowsiness, with potentially fatal consequences," said Dr. Sammy Almashat, a researcher with Public Citizen's Health Research Group who noted that suvorexant stays in the body longer than all but one other sleep drug."
 
2013-05-23 02:37:19 AM  

Abacus9: fusillade762: scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...

Why does it seem like every other drug these days causes suicidal thoughts?

I hear they got a pill for that now, but it causes impotence, which...


Does it come with frogurt?
 
2013-05-23 02:37:56 AM  
Yet Ambien is legal?

This is their actual disclaimer:
==============
"After taking Ambien, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Ambien. Reported activities include:
- driving a car ('sleep driving')
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Call your doctor right away if you find out that you have done any of the above activities after taking Ambien."
================

Wait, DRIVING WHILE ASLEEP?
The first time I heard that commercial, I thought I was hearing things.
 
2013-05-23 02:40:00 AM  
I'm terrified that Ambien is going to get banned because people keep taking it and doing stupid shiat.  It's the only sleep med I've found that actually puts me to sleep and doesn't leave me groggy and hangover feeling the next day.  When I first got it, the doc was cool about it.  A few doctors later and they're eyeing me up like I'm some kind of junkie there to get some pain pills.  One of them offered me farking Xanax over Ambien just because Ambien had been in the news so much lately, but that's another one of those 12 hours of unconscious wake up with a hangover meds.

Mark my words: Someone put a hit out on Ambien, I bet someone's about to come out with an Ambien clone and try to get it patented.
 
2013-05-23 02:41:39 AM  

miss diminutive: Bumblefark: ecmoRandomNumbers: Whatever happened to old fashioned home remedies like washing down two Vicodin with a fifth of vodka?

Heh. Getting a kick...

/...and a little woozy.

//Um...does anybody know if it's normal for a human liver to make a sound. Because, I think mine just made a sound.

///...a very, very bad sound.

Did you just promise to give up drinking? That was probably a shout of joy.


Heh. I promised nothing.

NOTHING!

thetestmarketevolution.com
 
2013-05-23 02:43:15 AM  

fusillade762: Abacus9: fusillade762: scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...

Why does it seem like every other drug these days causes suicidal thoughts?

I hear they got a pill for that now, but it causes impotence, which...

Does it come with frogurt?


viagra-infused frogurt, which also has some unfortunate side effects, but i'm sure there are some other prescription drugs to take care of those.
 
2013-05-23 02:51:58 AM  

fusillade762: Abacus9: fusillade762: scottydoesntknow: The drugs are designed to help people fall asleep and stay asleep.

The FDA's reviewers pointed to an increase in the risk - especially at the higher doses - of suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances.

Well, I guess they're right...

Why does it seem like every other drug these days causes suicidal thoughts?

I hear they got a pill for that now, but it causes impotence, which...

Does it come with frogurt?


Unfortunately, no. That's the problem.
 
2013-05-23 02:54:31 AM  

TommyymmoT: Yet Ambien is legal?

This is their actual disclaimer:
==============
"After taking Ambien, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Ambien. Reported activities include:
- driving a car ('sleep driving')
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Call your doctor right away if you find out that you have done any of the above activities after taking Ambien."
================

Wait, DRIVING WHILE ASLEEP?
The first time I heard that commercial, I thought I was hearing things.


The making food activity always struck me as funny. Would you actually make something edible, like an omelet or just start randomly adding ingredients into a pot until you end up with watermelon, shrimp and horseradish stew?

The sex one really has some interesting implications. If you have sex while asleep, did you really give consent?
 
2013-05-23 02:56:05 AM  

miss diminutive: TommyymmoT: Yet Ambien is legal?

This is their actual disclaimer:
==============
"After taking Ambien, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Ambien. Reported activities include:
- driving a car ('sleep driving')
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Call your doctor right away if you find out that you have done any of the above activities after taking Ambien."
================

Wait, DRIVING WHILE ASLEEP?
The first time I heard that commercial, I thought I was hearing things.

The making food activity always struck me as funny. Would you actually make something edible, like an omelet or just start randomly adding ingredients into a pot until you end up with watermelon, shrimp and horseradish stew?

The sex one really has some interesting implications. If you have sex while asleep, did you really give consent?


Or ask for consent?
 
2013-05-23 02:57:07 AM  
"

Hrist: Mark my words: Someone put a hit out on Ambien, I bet someone's about to come out with an Ambien clone and try to get it patented.


First, they came for the Vicodin, and I said nothing (with a smile).
Then, they came for the xanax, and I said nothing (while slightly drooling and mumbling incoherently).
Last, they came for the ambien - but luckily I woke up at the canadian border, having driven several hundred miles (while mumbling incoherently)...
 
2013-05-23 02:57:13 AM  
Is there such a thing as "sleep rape" ?
 
2013-05-23 02:57:40 AM  

Hrist: I'm terrified that Ambien is going to get banned because people keep taking it and doing stupid shiat.  It's the only sleep med I've found that actually puts me to sleep and doesn't leave me groggy and hangover feeling the next day.  When I first got it, the doc was cool about it.  A few doctors later and they're eyeing me up like I'm some kind of junkie there to get some pain pills.  One of them offered me farking Xanax over Ambien just because Ambien had been in the news so much lately, but that's another one of those 12 hours of unconscious wake up with a hangover meds.

Mark my words: Someone put a hit out on Ambien, I bet someone's about to come out with an Ambien clone and try to get it patented.


They may have been eying you as a function of "a few doctors later" and "terrified."
 
2013-05-23 03:00:25 AM  

TommyymmoT: Is there such a thing as "sleep rape" ?


I guess technically there is. If someone resisted the act would that be enough to wake someone on Ambien?
 
2013-05-23 03:00:34 AM  

miss diminutive: The making food activity always struck me as funny. Would you actually make something edible, like an omelet or just start randomly adding ingredients into a pot until you end up with watermelon, shrimp and horseradish stew?


You're sounding as if you don't like watermelbalaya.
 
2013-05-23 03:01:57 AM  

Abacus9: miss diminutive: The making food activity always struck me as funny. Would you actually make something edible, like an omelet or just start randomly adding ingredients into a pot until you end up with watermelon, shrimp and horseradish stew?

You're sounding as if you don't like watermelbalaya.


It's no honeydew chowder.
 
2013-05-23 03:08:28 AM  
I love how we're all discussing prescription sleep medications on Fark at 3 in the morning.
 
2013-05-23 03:09:34 AM  

miss diminutive: TommyymmoT: Is there such a thing as "sleep rape" ?

I guess technically there is. If someone resisted the act would that be enough to wake someone on Ambien?


Actually, I'm wondering about other activities.
A normal person might get out of bed(while asleep), and decide they need to drive down to the mini mart for a jar of olives that they meant to pick up earlier..
Whereas a normally violent type, might decide to get out of bed, and murder the dog because he meant to do so earlier.
 
2013-05-23 03:10:21 AM  
That's not so bad.  I happened across a package of sleeping pills marked with "non-drowsy formula".  In retrospect I should have bought it for the laughs.
 
2013-05-23 03:12:29 AM  
Too much pharma.

/sleep paralysis sucks ass, but when I've had it it's been narcotically induced and thus my fault.
 
2013-05-23 03:13:00 AM  

Dow Jones and the Temple of Doom: I love how we're all discussing prescription sleep medications on Fark at 3 in the morning.


Some people sleep during the day. I see your point though, it's sort of funny.
 
2013-05-23 03:18:04 AM  

Dow Jones and the Temple of Doom: I love how we're all discussing prescription sleep medications on Fark at 3 in the morning.


2 am where I'm at.

That's TOTALLY different,

/fine. I'll call for the refill in the morning...
 
2013-05-23 03:41:16 AM  

Dow Jones and the Temple of Doom: I love how we're all discussing prescription sleep medications on Fark at 3 in the morning.


It's 8:00 am here. No need to be a provincial jackass. :)
 
2013-05-23 03:43:40 AM  
The FDA just wants a bigger kickback. They don't really care about people.
 
2013-05-23 03:45:25 AM  

TommyymmoT: Is there such a thing as "sleep rape" ?


IIRC, there was a case where someone on ambien walked into the living room and started having sex with their daughter's friend who was staying the night. When the police arrested him, he had no idea where he was and what had happened. The guy got off (no pun intended) because he wasn't even in his right mind when he did the act.
 
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