Ambien was taken for sleep in American’s for almost 20 years. However, FDA- food and drug administration got complaints that taking that drug made them drowsy the next morning and sometimes led to accidents.
After test on drowsiness risk on driving, the agency said on Thursday that woman should take half the drug.
This applies to the drugs containing Zolpidem. Half dose ensures that less drug remains in the blood and people can drive in the morning.
There is an increased usage of these sleeping pills due to the fast life. As per IMS which a healthcare and technology company, it says that in 2011 there were almost 60 million prescriptions, which was 20% then 2006 and 40 million were for products that was having Zolpidem.
The recommendation was mainly based for women because the mobilization takes longer in them as compared to men. Almost 10% to 15% of women will have the drug in their blood after 8 hours and compared to only 3% men, as said by Dr. Robert Temple, Officer, Center for Drug Evaluation and Research.
There were many reports in regards to problems caused after the use of sleeping pills, and doctors have questioned why it took time for the agency to act so late. The effects are driving in sleep, eating, texting having sex and no memory of the same in the morning, these are all well known.
As said by Daniel Carlat, Associate Clinical professor, Psychiatry, Tufts University, “the agency is behind to pass the recommendation as the doctors are well aware of the conditions like this. This will be good as the patients will ask proper dose.”
Agency said that there were 700 complaints about driving accident and Zolpidem intake, for many years, there was a spike in 2007, when the label was changed and more people complained. But a connection between the report and the drug was not easy to make, as they did not remembered the time of pill intake as they were drinking.
Until the time when agency performed controlled test of Inetrmezzo to get driving simulation, approved in 2011 for walking in mid of night, then they were aware of the risk. The driving simulation was then associated with the quantity of Zolpidem in the blood, if there was 50nanograms/milliliter that can cause accidents, as confirmed by Dr. Ellis Unger, Agency officer, Center for Drug Evaluation and Research.
Dr. Unger also said that all sleeping pills manufacturers have to perform driving trials; however a spokesperson said that it is not necessary. Dr. Unger also added that it is a big problem and he is not sure why this decision was taken so late.
For the immediate release products such as Zolpimist, Edluar and Ambien, the normal dosage needs to be lessened to5mg from 10mg. For extended release it has to be lessened to 6.25mg from 12.5mg. Most of Zolpidem containing drugs are now generic.
For men the label should state that lower dose should be considered.
Patient’s prescribed higher dose should take them but agency said that they should speak with their doctors about lowering them as doctors can again switch to higher one of the lower is not working, as said by Dr. Unger lower doses are available they are used in older patients.
The manufacturer of Ambien CR and Ambien is Sanofi, they said that, it is always recommended to check with your doctor for dosage and also to know what it is; the label has important information. Company is supporting the clinical trials that are required for efficacy and safety.
Dr. Unger said that there are reports that Zolpidem causes sleep walk, hence the lowering of the dose may lower this, though it is not as strong as drowsiness in the morning. One of the patients of Dr. Carlat was gaining weight as was not able to remember the midnight trips that he use to do to the kitchen.
Dr. Daniel Kripke, Professor, Psychiatry, University of California, he agreed to the move with happiness but at the same time he wants the agency to look for other side effects as well.
He said it is a good move and in a right way. He also said that sleeping pills increase the sleep by 20 mins but can hamper the next day’s performance.
Agency’s critic said that on the Intermezzo label, there is a clear warning for women; hence agency was well aware about the problem.
However Thomas Roth, Director, Sleep center, Henry Ford Hospital, Detroit, also sleeping pills makers’ consultant, said that agency was concerned about the sleepy driving, but now they care more, the lowered dose will surely help in this.
Agency said that every patient will have different dose and they will be prescribed accordingly, however the dosage will be as lowest as possible.
Dr. Daniel J. Buysse, Professor, Psychiatry, University of Pittsburgh School of Medicine, said that he has started telling the patient to take half dose if required by telling to cut the tablet half.
Also said that we will have to be more attentive in this and will not have big effect in what he has done.
After test on drowsiness risk on driving, the agency said on Thursday that woman should take half the drug.
This applies to the drugs containing Zolpidem. Half dose ensures that less drug remains in the blood and people can drive in the morning.
There is an increased usage of these sleeping pills due to the fast life. As per IMS which a healthcare and technology company, it says that in 2011 there were almost 60 million prescriptions, which was 20% then 2006 and 40 million were for products that was having Zolpidem.
The recommendation was mainly based for women because the mobilization takes longer in them as compared to men. Almost 10% to 15% of women will have the drug in their blood after 8 hours and compared to only 3% men, as said by Dr. Robert Temple, Officer, Center for Drug Evaluation and Research.
There were many reports in regards to problems caused after the use of sleeping pills, and doctors have questioned why it took time for the agency to act so late. The effects are driving in sleep, eating, texting having sex and no memory of the same in the morning, these are all well known.
As said by Daniel Carlat, Associate Clinical professor, Psychiatry, Tufts University, “the agency is behind to pass the recommendation as the doctors are well aware of the conditions like this. This will be good as the patients will ask proper dose.”
Agency said that there were 700 complaints about driving accident and Zolpidem intake, for many years, there was a spike in 2007, when the label was changed and more people complained. But a connection between the report and the drug was not easy to make, as they did not remembered the time of pill intake as they were drinking.
Until the time when agency performed controlled test of Inetrmezzo to get driving simulation, approved in 2011 for walking in mid of night, then they were aware of the risk. The driving simulation was then associated with the quantity of Zolpidem in the blood, if there was 50nanograms/milliliter that can cause accidents, as confirmed by Dr. Ellis Unger, Agency officer, Center for Drug Evaluation and Research.
Dr. Unger also said that all sleeping pills manufacturers have to perform driving trials; however a spokesperson said that it is not necessary. Dr. Unger also added that it is a big problem and he is not sure why this decision was taken so late.
For the immediate release products such as Zolpimist, Edluar and Ambien, the normal dosage needs to be lessened to5mg from 10mg. For extended release it has to be lessened to 6.25mg from 12.5mg. Most of Zolpidem containing drugs are now generic.
For men the label should state that lower dose should be considered.
Patient’s prescribed higher dose should take them but agency said that they should speak with their doctors about lowering them as doctors can again switch to higher one of the lower is not working, as said by Dr. Unger lower doses are available they are used in older patients.
The manufacturer of Ambien CR and Ambien is Sanofi, they said that, it is always recommended to check with your doctor for dosage and also to know what it is; the label has important information. Company is supporting the clinical trials that are required for efficacy and safety.
Dr. Unger said that there are reports that Zolpidem causes sleep walk, hence the lowering of the dose may lower this, though it is not as strong as drowsiness in the morning. One of the patients of Dr. Carlat was gaining weight as was not able to remember the midnight trips that he use to do to the kitchen.
Dr. Daniel Kripke, Professor, Psychiatry, University of California, he agreed to the move with happiness but at the same time he wants the agency to look for other side effects as well.
He said it is a good move and in a right way. He also said that sleeping pills increase the sleep by 20 mins but can hamper the next day’s performance.
Agency’s critic said that on the Intermezzo label, there is a clear warning for women; hence agency was well aware about the problem.
However Thomas Roth, Director, Sleep center, Henry Ford Hospital, Detroit, also sleeping pills makers’ consultant, said that agency was concerned about the sleepy driving, but now they care more, the lowered dose will surely help in this.
Agency said that every patient will have different dose and they will be prescribed accordingly, however the dosage will be as lowest as possible.
Dr. Daniel J. Buysse, Professor, Psychiatry, University of Pittsburgh School of Medicine, said that he has started telling the patient to take half dose if required by telling to cut the tablet half.
Also said that we will have to be more attentive in this and will not have big effect in what he has done.
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