Food and Drug Administration FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use.
Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.
FDA urges health care professionals to caution all patients men and women who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs Ambien CR and generics.
Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. 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 has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products Ambien, Edluar, and Zolpimist and from What is zolpidem? Why is FDA requiring the manufacturers of certain zolpidem-containing products to revise the labeling to lower the recommended dose of zolpidem for women and to recommend consideration of the lower dose in men?
What should patients currently taking the 10 mg or Will a lower dose of zolpidem be effective in treating insomnia?
Is FDA requiring the manufacturer of Intermezzo zolpidem tartrate sublingual tablets to also change the dosing recommendations? A zolpidem overdose requires immediate attention. Call emergency services or a national poison control hotline if you suspect someone has overdosed.
If the person has stopped breathing or lost consciousness, call immediately. The most effective way to avoid a zolpidem overdose is to avoid using the drug. If you and your doctor have determined that Ambien is necessary for your overall health, make sure you only take the drug as prescribed.
If you are currently misusing or addicted to Ambien, take action to regain control over your life. Black Bear Lodge offers a safe haven for healing and recovery. This can decrease the amount of oxygen in your blood. If you have myasthenia gravis, you may already have lower oxygen levels.
For people with sleep apnea: This drug may slow your breathing or make it shallow. If you have sleep apnea, you may already have lower oxygen levels. For people with liver disease: If you have liver problems or a history of liver disease, you may not be able to process this drug well.
This may increase the levels of the drug in your body and cause more side effects. It may also cause a serious condition called hepatic encephalopathy. With this condition, the poor function of your liver causes problems with the way your brain works. Symptoms can include being confused, forgetting things, and slurring your speech.
If you have severe liver damage, you should not use zolpidem. Research in animals has shown negative effects to the fetus when the mother takes zolpidem. Studies have shown that when mothers take this drug late in their third trimester, their newborns can have slowed breathing and excessive sleepiness. Your doctor will monitor your newborn closely if exposure to zolpidem occurred during your pregnancy. This drug should only be used if the potential benefit justifies the potential risk.
And call your doctor right away if you become pregnant while taking this drug. For women who are breastfeeding: Zolpidem may pass into breast milk and cause side effects in a child who is breastfed.
Talk with your doctor about breastfeeding your child. You may need to decide whether to stop breastfeeding or stop taking this medication. For seniors: The liver of an older adult may not work as well as it used to.
This raises your risk for side effects, such as sedation and decreased alertness. You may also be more sensitive to these effects.
Zolpidem oral tablet is used for short-term treatment. Withdrawal symptoms can include muscle cramps, vomiting, sweating, flushing reddening and warming of your skin , and emotional changes. These can include nervousness, panic attacks, or uncontrollable crying. Never stop taking this drug without talking to your doctor. If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:.
But if your symptoms are severe, call or go to the nearest emergency room right away. How to tell if the drug is working: You should have an easier time falling asleep and staying asleep.
A prescription for this medication is refillable. Since zolpidem is a Schedule IV controlled substance, your doctor may refill this medication up to five times in 6 months. Your doctor will write the number of refills authorized on your prescription. You and your doctor should monitor certain health issues during your treatment. This can help make sure you stay safe while you take this drug.
These issues include:. Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.
There are other drugs available to treat your condition. Although it is not a narcotic, the drug is a depressant that produces calming effects on the body, therefore, you can get high on Ambien if you abuse it. If a person swallows Ambien, the high will set in around 30 minutes after taking the drug and last for several hours. If someone is snorting Ambien, the high may set in faster, but last for a shorter period of time.
Some people who are addicted to Ambien will abuse it by injecting it intravenously for an even stronger, more powerful high. When someone gets high on Ambien, they will feel extremely groggy, drowsy, and euphoric. They may also begin to have auditory or visual hallucinations. Oftentimes, the effects of Ambien abuse will look similar to alcohol or benzodiazepine intoxication. Ambien abuse occurs in many different forms. For example, taking the drug without a prescription, purchasing the drug on the streets, taking a higher dose than what you are prescribed, or snorting or injecting Ambien are all forms of drug abuse.
Some people believe that Ambien is safer than some other benzodiazepines because there is a lower potential for overdose. While users may need to take more Ambien to overdose than they would other benzodiazepines, the signs and symptoms of an Ambien overdose are difficult to detect. In most cases, the symptoms simply mirror those of Ambien intoxication.
When taken in large doses, Ambien slows down breathing, heart rate, and other essential bodily functions.