Hello Guest, Welcome to Apnea Board !
As a guest, you are limited to certain areas of the board and there are some features you can't use.
To post a message, you must create a free account using a valid email address.

or Create an Account

New Posts   Today's Posts

[News] FDA Requiring Lower Dose for Insomnia Meds
FDA Requiring Lower Dose for Insomnia Meds
FDA Requiring Lower Recommended Dose for Insomnia Meds

The US Food and Drug Administration is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses.

New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours.

Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.

Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.

The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia," said Ellis Unger, MD, director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. "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."

Fair use from:

The above post may contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. The material available is intended to advance the understanding of Sleep Apnea treatment and to advance the educational level of Sleep Apnea patients with regard to their health. Sometimes included is the full text of articles and documents rather than a simple link because outside links frequently "go bad" or change over time. This constitutes a "fair use" of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material in this post is distributed without fee or payment of any kind for research and educational purposes. If you wish to use copyrighted material from this post for purposes of your own that go beyond "fair use", you must obtain permission from the copyright owner.
Post Reply Post Reply

Donate to Apnea Board  
RE: FDA Requiring Lower Dose for Insomnia Meds
Maybe you just need some "Puppy Uppers"?

"With ordinary talent and extraordinary perseverance, all things are attainable." - Thomas Foxwell Buxton

Post Reply Post Reply
RE: FDA Requiring Lower Dose for Insomnia Meds
That's quite a drop in the dosage. I wonder if there were accidents associated with it's use.
Remember when people were taking halcion and killing their spouse in the middle of the night and pleading "not guity" because they were under the influence of the drug.
From 1993-

PONTIAC, MICH. — A man who said the sleeping pill Halcion drove him to shoot his wife to death was found innocent by reason of insanity. John Caulley admitted donning a mask and ambushing his estranged wife, Kathleen, outside their Troy home in 1988. The 44-year-old former stockbroker had started taking the prescription drug three months earlier. Critics have said Halcion can cause serious side effects, including short-term memory loss, violent behavior and hallucinations. The federal Food and Drug Administration concluded in 1992 it was safe and effective when used as directed. Caulley was convicted of first-degree murder in 1990. But an appeals court ordered a new trial, saying the jury should have been instructed to consider the effects of Halcion.
Post Reply Post Reply
RE: FDA Requiring Lower Dose for Insomnia Meds
"NSAIDs such as ibuprofen, naproxen, Voltaren, Celebrex and others provide relief for those who suffer from painful arthritis, lupus or other debilitating conditions. But when these patients also have heart trouble, the drugs' use is cause for concern."

I was on Celebrex when it first was approved for OTC sales.
It worked great for joint pain...but it also sent me to the ER with atrial fibrilation. (No previous heart issues!! )

My point is, FDA will APPROVE lots of things that are still bad for you.
"With ordinary talent and extraordinary perseverance, all things are attainable." - Thomas Foxwell Buxton

Post Reply Post Reply

Donate to Apnea Board  

Possibly Related Threads...
Thread Author Replies Views Last Post
  Insomnia and treatment? ECM5 5 243 06-20-2022, 01:12 PM
Last Post: ECM5
  [Pressure] Lower respiratory rate after EPR, ok or too low? cupcakechinchilla 8 322 06-17-2022, 03:25 PM
Last Post: DaveL
  Lower altitidue & improved Sp02 readings MCS2014 4 270 01-17-2022, 10:27 AM
Last Post: staceyburke
  Lower Preasure = No Leak and No Limits and No Events? tierdal 1 359 08-12-2021, 11:43 AM
Last Post: SarcasticDave94
  [CPAP] AHI hovering around 10, how to lower? Vultures 11 647 07-30-2021, 06:11 AM
Last Post: ICEMAN
  Upper and lower pressure settings?? Mpsleep 1 302 07-27-2021, 07:10 AM
Last Post: OpalRose
  suggestions to lower ahi Purr3k 27 1,150 05-22-2021, 06:17 AM
Last Post: DaveL

New Posts   Today's Posts

About Apnea Board

Apnea Board is an educational web site designed to empower Sleep Apnea patients.