![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by herpills on January 10, 2013, at 12:50:17
By MATTHEW PERRONE AP Health Writer
WASHINGTON January 10, 2013 (AP)The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.
The agency said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with morning driving, which increases the risk of car accidents.
Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly. Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.
The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.
The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under brands including Ambien, Edluar and Zolpimist.
FDA officials say doctors should aim to prescribe the lowest dose possible that will successfully treat insomnia.
"Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate," said Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation.
Unger said in a statement that the FDA has received a number of reports of car accidents connected to zolpiderm over the years. However, the agency did not have enough information to tell how much of a role the drug played in the incidents.
The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving.
For now, patients should continue taking their currently prescribed dose until they can talk to their doctor about the best way to proceed.
Ambien is sold by Sanofi, Edluar by Meda Pharmaceuticals Inc. and Zolpimist by NovaDel Pharma Inc.
Posted by Phillipa on January 10, 2013, at 14:59:03
In reply to FDA Requires Lower Doses for Sleep Drugs, posted by herpills on January 10, 2013, at 12:50:17
Figures seems most of the meds sleeping and other are being prescribed in lower doses. Phillipa
Posted by Phil on January 10, 2013, at 15:20:21
In reply to FDA Requires Lower Doses for Sleep Drugs, posted by herpills on January 10, 2013, at 12:50:17
God has spoken.
Posted by jono_in_adelaide on January 10, 2013, at 18:31:29
In reply to Re: FDA Requires Lower Doses for Sleep Drugs » herpills, posted by Phil on January 10, 2013, at 15:20:21
I wonder if a 5mg dose will be adequate for sleep?
Posted by SLS on January 10, 2013, at 21:55:55
In reply to Re: FDA Requires Lower Doses for Sleep Drugs, posted by jono_in_adelaide on January 10, 2013, at 18:31:29
> I wonder if a 5mg dose will be adequate for sleep?
The same thing was done with Halcion (triazolam) many years ago. Both Halcion and Ambien are notorious for producing amnesic phenomena. Halcion was a great drug for initial insomnia. Combined with the longer acting Ativan, they both made for a great night's sleep.
- Scott
Posted by jono_in_adelaide on January 12, 2013, at 3:47:12
In reply to Re: FDA Requires Lower Doses for Sleep Drugs, posted by SLS on January 10, 2013, at 21:55:55
I remember my great grandmother being addicted to Mogadon sleeping pills, I think the half life is in excess of 24 hours, she must have been heavily sedated for most of my life
Posted by Phillipa on January 12, 2013, at 18:51:25
In reply to Re: FDA Requires Lower Doses for Sleep Drugs, posted by jono_in_adelaide on January 12, 2013, at 3:47:12
Jono what is this med? Another American name? Phillipa
Posted by jono_in_adelaide on January 13, 2013, at 17:24:15
In reply to Re: FDA Requires Lower Doses for Sleep Drugs » jono_in_adelaide, posted by Phillipa on January 12, 2013, at 18:51:25
I dont know that it was marketed in America, it was nitrazepam, similar drug to Dalmane, long acting benzo hypnotic very popular in the 60's and 70's in Australia, Canada, the UK and Europe.
My great grandmother had a stroke at 99, and was put in hospital, they discontinued the 2 Mogadon that she had taken every night for 30 years, and 2 days later she was psychotic.... they were pumping her full of haloperidon, and it suddently occured to me that she was having major denzodiazepine withdrawl..... i spoke to the head nurse, they gave her 10mg of Valium and within an hour the psychosis was gone
Posted by Phillipa on January 13, 2013, at 20:36:26
In reply to Re: FDA Requires Lower Doses for Sleep Drugs, posted by jono_in_adelaide on January 13, 2013, at 17:24:15
Jono I saw this happen to a man who had had surgery. When a patient goes to surgery all prior DR orders are cancelled and the surgeon writes new orders after surgery. This poor man's surgeon didn't see he been on I think it was 4mg of xanax and didn't write an order for it. He became combative and was restrained in a chair. The error was picked by the RN's and his xanax restarted and he was fine. Your poor grandmother. Phillipa
Posted by elanor roosevelt on January 21, 2013, at 21:34:02
In reply to Re: FDA Requires Lower Doses for Sleep Drugs » jono_in_adelaide, posted by Phillipa on January 13, 2013, at 20:36:26
I take 15mg of Ambien
Now I'm being prescribed 10mg (which doesn't do anything but annoy me) so I will continue with 15mg 20 days a month and 10 nights I will use 1mg of klonopin which I don't like for sleepingso stupid
Posted by herpills on January 25, 2013, at 13:34:04
In reply to Re: FDA Requires Lower Doses for Sleep Drugs, posted by elanor roosevelt on January 21, 2013, at 21:34:02
> I take 15mg of Ambien
> Now I'm being prescribed 10mg (which doesn't do anything but annoy me) so I will continue with 15mg 20 days a month and 10 nights I will use 1mg of klonopin which I don't like for sleeping
>
> so stupidDid your doctor give a specific reason why he changed the dose, or did he just say "because the fda says I should"?
I just don't understand, hasn't Ambien been around for like 15 years, and they're just NOW saying women can't take a higher dose? herpills
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.