How many reports of zolpidem and impaired driving has FDA received? Were these reports used as evidence to support the proposed new dosing recommendations for certain zolpidem-containing products?
Zolpidem is a sedative-hypnotic sleep medicine that is used in adults for the treatment of insomnia. Zolpidem is available as an oral tablet Ambien and generics , an extended-release tablet Ambien CR and generics , a sublingual under-the-tongue tablet Edluar , and an oral spray Zolpimist.
Zolpidem is also available under the brand name Intermezzo, a lower dose sublingual tablet that is approved for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. FDA is requiring the manufacturers of certain zolpidem-containing products to revise the labeling to lower the recommended dose of zolpidem-containing medicines for women and to recommend that health care professionals consider prescribing the lower dose for men because next-morning blood levels of zolpidem may be high enough to impair activities that require alertness, including driving.
Patients with high levels of zolpidem can be impaired even if they feel fully awake. Zolpidem is eliminated from the body more slowly in women, so the drug can stay in their systems longer than it does in men. If you are currently taking the 10 mg or Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.
For men, FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses. These lower doses of zolpidem 5 mg for immediate-release products and 6. When Intermezzo was FDA-approved in November , the label already recommended a lower dosage in women compared to men. The recommended and maximum dose of Intermezzo is 1. In elderly patients, zolpidem blood levels can be higher, and the lower doses are already recommended.
The immediate-release tablets and Edluar sublingual tablets are used if you have trouble falling asleep. The extended-release tablets are used if you have trouble falling asleep or staying asleep. The low-dose 1. Zolpidem belongs to a class of drugs called hypnotics.
A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. Zolpidem increases the activity of GABA.
GABA is a chemical in your body that causes sleepiness. Increasing its activity helps you fall asleep. Zolpidem can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking zolpidem. This list does not include all possible side effects. For more information on the possible side effects of zolpidem, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.
If these effects are mild, they may go away within a few days or a couple of weeks. Call your doctor right away if you have serious side effects. Serious side effects and their symptoms can include the following:. Zolpidem oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects. Below is a list of medications that can interact with zolpidem.
This list does not contain all drugs that may interact with zolpidem. Before taking zolpidem, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use.
Sharing this information can help you avoid potential interactions. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. Taking zolpidem with certain medications raises your risk for side effects.
This is because zolpidem and these other medications can cause the same side effects. As a result, these side effects can be increased. Examples of these drugs include:. Taking zolpidem with certain medications raises your risk for side effects from zolpidem.
This is because the amount of zolpidem in your body may be increased. When zolpidem is used with certain drugs, it may not work as well to treat your condition. This is because the amount of zolpidem in your body may be decreased. The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
The liver of an older adult may not work as well as it used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk for side effects. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below.
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Please try again. Something went wrong on our side, please try again. Mayo Clinic Press Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Taken in this dosage, Ambien is generally very safe and will not put individuals at risk for overdose. However, exceeding this amount can dramatically increase the potential for negative side effects and overdose. Individuals can begin experiencing dangerous side effects of Ambien at doses starting at 70 milligrams.
Higher doses than this can result in an overdose. The more Ambien a person takes, the more at risk he or she is of overdosing. Additionally, taking Ambien in ways other than what is prescribed — such as snorting or injecting it — can also greatly increase the risk of overdose. Ambien overdose symptoms tend to be fairly easy to identify and often come on quickly after the drug is ingested. Due to the fast-acting sedative nature of the drug, a person can quickly fall unconscious and potentially go into a coma.
An Ambien overdose is often survivable if treatment is sought immediately. However, there have been fatalities reported as a result of an Ambien overdose.
Overdose-related deaths are more likely when other substances, such as alcohol, have been consumed alongside Ambien.
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