Lower Dosage Of Popular Medications For Sleeping, Required By FDA

FDA requires the manufacturing companies of particular sleeping medications like Ambien and Zolpimist to decrease the recommended dosages by half especially for women. The said agency says that the blood levels of these medications could still be high enough to affect the person’s activities in terms of alertness like driving. Also, FDA recommends the labeling of the medications suggest that doctors consider a lower does for men.

Check this out for more.

Females seem to be more vulnerable to the effect for the reason that they remove the drug’s active ingredient, zolpidem from their bodies in a much slower manner compared to men. This is according to FDA experts. This particular action can be applied to zolpidem products that are applied for use in bedtime, those that are marketed as generics and are under the brand names Ambien, Ambien CR, Edluar and Zolpimist. The data they have shown a huge risk of morning conditions prove the highest with the extended release forms of these drugs.

FDA statement notes says, “Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose, FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.”

These are the specific recommendations:

Zolpidem for women should be decreased from 10 mg to 5 mg. That’s for the immediate-release products like Ambien, Edluar and Zolpimist. On the other hand, for the extended-release products such as Ambien CR, the decrease is from 12.5 mg to 6.25 mg.

Doctors should also give the lowest dose when they prescribe Zolpidem and other insomnia drugs. They should also inform the patients that conditions from sleep drugs can become present even if they are fully awake. However, the recommended doses of Intermezzo which is a lower-dose Zolpidem and is also approved for treatment of middle-of-the-night awakenings are not to change. FDA has also prepared some FAQs to give a certain kind of overview for this safety issue.

You can get more information about this by visiting FDA website.  You can also click here for additional information.

Taking A Closer Look At Placebo

When we talk about placebo, you would think that the medicine is real, but the reality is that it isn’t. It can come in different forms like pill, shot or any kind of treatment as long as it’s fake. The common denominator among all placebo drugs is that they cannot cure any kind of medical condition. Get information from http://www.healthgrades.com/provider/hootan-melamed-y4jph.

So the next question is that, how is it being used? A lot of researchers make use of placebo drugs in their studies. It helps them a lot in understanding the effect of a new drug or other kind of treatments for any kind of disease or condition.  For example, participants of a certain study might be treated with a new drug to decrease his or her level of cholesterol. Other participants would get placebo drugs. No one in the study will be able to know if they are taking the real or the fake one.

The researchers will then make some comparison on the effects of the real and placebo drugs on the patients. This way, they will be able to comprehend how effective a new drug is and they would also know its side effects.

There are times a certain person can make a response to placebo treatments. It can be either positive or negative. Another example would be that the patient’s symptoms may have improvements. A certain person can also have side effects coming from the treatment. This is what we now call the “placebo effect.”

There are a few conditions wherein placebo treatments can lead to good results even though some people know that they are taking fake drugs. Studies have also shown some effects of placebo in certain conditions like depression, pain, sleep disorders and bowel diseases. In one particular study related to asthma, patients having placebo inhalers were not better on breathing tests than doing nothing at all. However, when researchers asked for the patient’s perception with regards to how they felt, the placebo inhaler proved to be as effective the real medicine when it comes to relief.

Some researchers on placebo effect looked at the relationship of mind and body. Among the most common theories, one says that its (placebo) because of a person’s expectations. If a particular person expects a certain pill to do something, it’s possible that his body’s chemistry will also react and cause some effects that are like an actual medication.

Studies also show that physical changes actually happen during the placebo effect. For example, research recorded an increase in the body’s endorphin production. This is our body’s natural pain reliever. The only problem about placebo drugs is that you can’t tell its effect from the actual medication. If researchers will be able to draw a line between these two, then drug testing cost will surely decrease. Placebo is a very promising tool in medicine. Hopefully, studies will improve its use in a more advanced level.

Visit Hootan Melamed for more information.