FDA Reduces Dosage Recommendations Of Sleeping Pills Containing Zolpidem
Editor's ChoiceMain Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jan 2013 - 13:00 PST
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opinionsFDA Reduces Dosage Recommendations Of Sleeping Pills Containing Zolpidem
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Manufacturers of sleeping pills with an active ingredient called zolpidem are being forced by the U.S. Food and Drug Administration (FDA) to reduce the current recommended dose of the medications. This measure comes following new evidence showing that the zolpidem blood levels of some people the day after taking the medications can severely impair their alertness and ability to perform tasks, such as driving or handling machinery.
Zolpidem remains in the blood the morning after taking it. By lowering the recommended dose of drugs with the ingredient inside, the blood level of zolpidem the morning after will be reduced. Women take longer than men to flush the ingredient from their system, the FDA has stated that the dosage for women will therefore be less than for men. Patients taking the extended-release forms of these drugs have the highest levels of the ingredient in their blood.
The FDA warns health care professionals of the importance in assuring that patients on these medications are completely aware of the risks associated with zolpidem.
For women, the recommended dosage of zolpidem found in instant release drugs (Edular, Ambien) will be lowered from 10 mg to 5mg, for extended-release drugs it will be lowered from 12.5 mg to 6.25 mg. Although men are able to eliminate the ingredient faster, the FDA still encourages doctors to consider prescribing the same dosages that are recommended to women.
According to Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research:
"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. 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."
Morning drowsiness and impaired alertness is not exclusively associated with zolpidem, the FDA reminded the public that there are many other insomnia drugs that also have the same side effect.
Those who are currently taking 10 mg or 12.5 mg doses of medications with zolpidem should carry on with their prescribed dose before talking to their doctor who will evaluate how to continue with the drug. People on the medication need to talk to their doctors to find an appropriate dose.
The change comes after a laboratory study and driving simulation revealed an increased risk of motor vehicle accident while zolpedim is still in a person's blood, as may occur the morning after taking some insomnia medications.
Dr. Unger. concluded:
"Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people's mental alertness and ability to drive. Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment."
More research will be carried out by the FDA to fully understand the risks of all the other insomnia drugs on the market.
A previous study published in Behavior Therapy revealed that in some instances, taking insomnia medication is not the best form of therapy in the long run, due to it's numerous side effects.
Written by Joseph Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
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Visitor Opinions (latest shown first)
modern testing devices confirm levels of Zolpidem remaining in patients' blood after a full nights sleep
posted by Dr. Walita Goodstein on 29 Jan 2013 at 4:54 pmAs a medical practitioner, modern testing devices confirm levels of Zolpidem remaining in patients' blood after a full nights sleep. Needless to say, this varies with the patient's weight and metabolism. In my opinions, patients must me monitored, carefully at first, and then through periodic follow ups to determine if Zolpidem is having any adverse effects on patients' lives, both physically and physcholgically. There is a trade off between patient functionality improvement and detrimental effect(s). Practitioners must use their best judgement to strike the right balance. The right balance often involves personal experience and reports from other patients and from industry trade journals and so it help if the practitioner has some insight into the patients' life. There is no "one size fits all" therapy. Therefore, depending on circumstances, between men and women ad depending on circumstances, 5, 10, 6.25mg CR, and 12.5mg CR (not to mention the new Intermezzo aublingual product) may be indicated for short term of for longer periods of therapy. I don't believe that the responsible physician would look to a "one size fits all" regulation" to manage patient symptoms. If patient sleep symptoms are not properly managed, other more deleterious may manifest themselves - both organic and psychological - over the long term. The relative safety record of Zolpidem, couples with it's short half life, makes it an ideal candidate for inclusion in an "arsenal" of effective remedies. Dr. Walita Goodstein, 29 Jan 2013, New York City, w.reses@yahoo.com.
Very Good Point, Doctor!
posted by Richard on 17 Jan 2013 at 8:07 amDr. Campbell:I agree Elderly are tough, with any issues. Require case by case judgement by good men like yourself. Fortinately, they usually don't have long commutes, etc. My experience re:supervised care is that ativan,.5 mg, metabolizes more completely in some elderly (assume liver age appropriate). Still have benzo half life issue, however. If can subsitute low dose benedyrl every 3rd day, it works. Anyhow, I understand and agree - You're good man., Doc.
My concerns on this relate to normally healthy, robust males working very long hours under unexpected exogenous ( non-neurotic ) stressors that will pass (sans therapy) in 1-3 months - if I can keep them together in the interm. Goodspeed. Like ObamaCare, FDA sometimes wants to treat every thing the same -loses vision of importance of the Medical Doc's direct, individual by individual judgement RW-------
FDA Zolpidemem recommendation Citation Incorrect
posted by Richard on 17 Jan 2013 at 7:30 amAs I suspected, the new data from "other studies" cited by FDA are either incorrect/inapplicable. The FDA's recent study cited to support it ruling to reduce recommendation on Zolpidemem in healthy adult males is a study done by the Ryerson's Sleep and Depression Laboratory(RSDL),under supervision of Dr. Colleen Carney, Director of(RSDL), with Andrea Harris et.al. lead gradute student. The Study included a online line questionnaire of 397 undergraduate students about their safety behaviors (gender unclear, age 18-29?), i.e. their routines to avoid being awake at night by taking a sleeping pill or drinking alcohol. The object was to determine whether cognitive therapy may not be the most effective way to get a better night's sleep in the long run for people suffering from insomnia. The study focus on data collected by a online survey in which undergraduate students were questioned about use of sleeping pills or Alchol and time, effort, etc. involved in the process of inducing sleep.(NO DATA WAS COLLECTED ON BRAND, DOSE OR MG, OF SLEEPING PILL RESPONDENTS WERE USING. As the study was supervised by Dr. Carney I do not question is scientific quality, nature of it's controls, replicability, statistical significance of sample size, etc. However, I do doubt that the RSDL ever condoned the FDA's use of it's study to economically target a specific product (Zolpidemem) or Pharamacutial Company.
Zolpidem sleeping pills
posted by Richard campbell,md on 12 Jan 2013 at 3:24 pmUse in older. Patients have been assoc with memory loss.as recently to close family member with poss. Dx of early asheimers by neurologist. Decreased dose to 5 mg.memory much improved.not my first expiernce with this in long time use in elderly.
FDA Dosage Recommendation Inconsistenant with Own Findings
posted by Richard on 11 Jan 2013 at 1:47 pmIt appears FDA has been working a long time to justify reducing the dosage of Zolpidem. This time, FDA applied their findings on Zolpidem inconsistently, and perhaps with sexual discrimination, when it unilaterally recommended new information on women's metabolic prcessing times for Zolpidem, to the entire population. FDA found that for SOME women, 10 mg of Zolpidem appeared to process, in their opinion, to slowly for early am driving. In making the final "recommendation" FDA ignored it's own gender specific findings and with no real justification, included men, as well. I find it particularly disturbing that I can not find any consideration of the counter effect or such a recommendation: avoiding an accidents caused by Men suffering sleep deprivation, e.g. nodding off on the way home; nodding off and head on into another car.
I am a man, 6'4" tall,210 lbs, and I find I have to take 2 weeks on, two weeks off Zolpidem,10mg for it to be effective.
The role of FDA as "big brother" is an ongoing issue. A growing group of FDA's "clients", myself included, don't like the way are being treated. We are conservate, moderate and liberal in affiliation. We see the FDA as in our lives, questioning us and our Medical Doctors. We see the FDA constantly tightly regulating any product that might be helpful citizens while failing to protect us by NOT considering the consequences it's actions on sleep deprived driving, especially in men.
Ambien
posted by dj4421 on 10 Jan 2013 at 2:43 pmI've taken 10 mil. Ambien for a number of years and have never had any adverse effects. I think the longer you take it the less effect it has. Even after only 4 or 5 hrs. of sleep on the drug I wake up fully alert.
Physician [MD, FACS, FCCP, FACC
posted by David, MD on 10 Jan 2013 at 2:20 pmCongratulations!
This is an important, timely article, very well written, with succinctly-expressed information. It merits being distributed to lay media, as well as being brought to the notice of more medical professionals.
Take away another med that works well for most because of a few.
posted by Steve on 10 Jan 2013 at 2:01 pmAfter working with my physician for many years on insomnia Zolpidem simply works. I've tried everything from hypnosis to melatonin and other OTC concoctions, some of which work for short durations. I know some people would like to stop the rest of us from using something that didn't work for them or that they are opposed to for personal reason, my answer is just don't. But do not stop access to those of us who are so glad they found something that works so well for them and doesn't leave them drowsy or drugged the next morning. Please do not go the way of "pseudophedrines" because some find ways to abuse it.
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