Warnings for Sleeping Pills (May 2007)

There are now stronger warnings on the possible risks of taking drugs to treat sleep disorders - drugs such as Ambien (zolpidem tartrate), Lunesta (eszopiclone) and Restoril (temazepam). FDA is asking all manufacturers of sedative-hypnotic drugs to strengthen the language in the product labeling about two issues: severe allergic reactions, and unusual behavior in patients who take these products.

The warnings will point out that anaphylaxis and angioedema have been reported in patients as early as the first time the drugs are taken. In addition, the label will warn that patients on these drugs have engaged in certain behaviors after having gone to sleep, such as driving or eating, often with no recollection of the event.

Although all sedative-hypnotic drugs have these risks, there may be differences among these products in how often they occur. Because of this, FDA is recommending that the drug makers conduct clinical studies to investigate how often sleep-driving and other unusual behaviors occur with their products.

The manufacturers will also be developing Medication Guides to be given to patients whenever the drug is dispensed. The guide will explain the drug's proper use, its risks, and precautions patients should take while using it. This includes avoiding alcohol and other central nervous system depressants because they can increase the risk of sleep-driving and other unusual behaviors.

Sleep Disorder (Sedative-Hypnotic) Drugs:

• Ambien, Ambien CR (zolpidem tartrate)
• Butisol sodium
• Carbrital (pentobarbital and carbromal)
• Dalmane (flurazepam hydrochloride)
• Doral (quazepam)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital sodium)
• Sonata (zaleplon)

Additional Information:

FDA MedWatch Safety Alert. Sedative-hypnotic drug products. March 14, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative

FDA Office of Women's Health. Sleep Disorders. 2006.
http://www.fda.gov/womens/getthefacts/sleep.html

Category:

News & Politics

Tags:

• Sleeping
• Pill
• Warning
• FDA
• Ambien
• Lunesta
• Severe
• Allergic
• Reaction
• Unusual
• Behavior
• Anaphylaxis

[carterwatrous]

WHAT THE FUCK IS Rozerem (ramelteon) DOING IN THIS LIST....

ROZEREM IS NOT A FUCKING HYPNOTIC-SEDATIVE AND DOES NOT WORK ON GABA RECEPTORS SUCH AS BENZODIAZEPINES AND HYPNOTICS.

[Globodyne]

I love the 30mg Adderall XR pills shown at the end :D They look yummy.

[greenmisc]

@Pent5HT wow! i take clonazepam(its a benzodiaxepine )and works great! I once was on Xanax and wow. i did some fucked up shit on that! Wrecked a car,filled the sink with oatmeal!. Take off in my truck until i run out of gas and left it in the streets and walked back to the apartment and passed out...yelling and screaming while i was sleeping...(scared the shit out of my roomate) I will never do xanax again!

[Pent5HT]

O SHIT I TAKE HALCION!!!!!!!! Ambien made me sleep walk and do stuff without remebering!!!!!! i wokeup and my ROOM WAS TRASHED! And everything was smashed and destroyed! And my mom said she had to babysit me for 5 hours on ambien! I WAS LIKE WTF! so i stopped taking it! And now my doc is giving me halcion cuz he said it wont make me sleepwalk like ambien!!!! Does halcion make u sleep walk????? im on .25 MG :S my doc said it wont cause sleep walking but idk. cuz ambien was a NIGHTMARE!

[IcePrincess619]

I need one right now. I don't have a sleeping problemd

[OmegaPiggy77]

i love how theres a picture of adderall xr next to the wine glass when she's talking about other sedatives. Adderall is a STIMULANT, not a depressant! and seriously peeps barbituates are NOT a healthy solution, those fuckers kill so many people accidentally. at least benzo's like temazepam have very little affect on one's CNS.

[Globodyne]

yeah right like the generic manufacturer of Quazepam or Temazepam is gonna pay to conduct studies on their expired patent drugs.

[MultiSpinners]

ohh man-_-

[DendrilopisXaggro]

secobarbital its the key to the happy garden of dreams

[Nguli34689]

Placidyl (ethchlorvynol) was discontinued over a decade ago. Seconal is available but not prescribed as often as it was 40 years ago. It is irrlelevant to mention Placidyl at this point in time. Further, considering the decomposition of this medication due to time, light, heat, and air, I think that Placidyl has expired some time ago.