Ambien CR

Ambien CR is a prescription medication used in adults for the short-term treatment of insomnia (difficulty falling asleep). Ambien belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.

Ambien CR comes in an extended release tablet form and is taken by mouth just before bedtime, without food.

Swallow Ambien CR whole. Do not crush, divide or chew Ambien CR tablets.

Common side effects of Ambien CR include daytime drowsiness, dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Ambien CR affects you.

Ambien CR is a prescription medicine used in adults for the treatment of a sleep problem called insomnia (difficulty falling asleep or staying asleep). It slows brain activity to allow sleep.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Warning: Impairment from sleep drugs can be present despite feeling fully awake.

You may still feel drowsy the next day after taking Ambien CR. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking Ambien CR until you are certain you are alert.

Serious side effects of Ambien CR may include:

• getting out of bed while not being fully awake and taking part in an activity that you do not know you are doing
• abnormal thoughts and behavior including:
  • more outgoing or aggressive behavior than normal
  • confusion 
  • agitation
  • hallucinations (seeing or hearing things that aren't there)
  • worsening of depression
  • suicidal thoughts or actions
• memory loss
• anxiety
• severe allergic reactions including:
• swelling of the tongue or throat
• trouble breathing
• nausea and vomiting

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Ambien CR.

The most common side effects of Ambien CR are:

• drowsiness
• dizziness
• diarrhea
• "drugged feelings"

Some people experience symptoms such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain after stopping sleep medicine. This may last a couple days. 

This is not a complete list of Ambien CR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Ambien CR with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers.

This is not a complete list of Ambien CR drug interactions. Ask your doctor or pharmacist for more information.

The FDA (U.S. Food and Drug Administration) lowered the recommended Ambien CR dose for women from 12.5 mg to 6.25 mg on January 10, 2013 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. Women appear to be more susceptible to this risk because they eliminate Ambien CR from their bodies more slowly than men.

After taking Ambien CR, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You should be aware that impairment from sleep drugs can be present despite feeling fully awake. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Ambien CR.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Ambien CR.

• Take Ambien CR right before you get in bed, not sooner.
• Do not take Ambien CR if you drink alcohol.
• Do not take Ambien CR with other medicines that can make you sleepy. 
• Do not take Ambien CR if you cannot get a full night's sleep or stay in bed 7 or 8 hours before being active again.
• Do not take Ambien CR if you are allergic to anything in it. Severe allergic reactions have occurred with Ambien CR use. Seek emergency medical attention if you have unexplained rash, itching, hives, wheezing or trouble breathing, or unexplained swelling (especially of the throat, lips, or mouth).

Ambien CR can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Ambien affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ambien CR there are no specific foods that you must exclude from your diet when receiving Ambien CR.

Before receiving Ambien CR, tell your doctor about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or are planning to breastfeed. Ambien CR is excreted into human milk. It is not known if Ambien will harm your nursing baby.

Take Ambien CR exactly as prescribed. Do not take more Ambien CR than prescribed for you.

• Take Ambien CR right before you get into bed.
• Do not take Ambien CR unless you are able to stay in bed a full night (7–8 hours) before you must be active again.
• Ambien CR should be taken without food. The effect of Ambien CR may be slowed if taken with or immediately after a meal
• Swallow Ambien CR whole. Do not crush, divide or chew Ambien CR tablets.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Take Ambien CR exactly as your doctor has prescribed it. Follow the directions on your prescription label carefully.

Ambien CR Extended-Release

The recommended dose of Ambien CR tablets for adult men is 12.5 mg once daily immediately before bedtime. The total Ambien CR  tablets dose should not exceed 12.5 mg per day.

For women, the recommended Ambien CR dose is 6.25 mg once daily immediately before bedtime. The FDA lowered the recommended dose for women from 12.5 mg to 6.25 mg for extended-release products on January 10, 2013. See above.

If you take too much Ambien CR call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Ambien CR at room temperature.
• Keep Ambien CR and all medicines out of reach of children.
• Ambien CR is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Ambien CR in a safe place to prevent misuse and abuse. Selling or giving away Ambien CR may harm others, and is against the law.

Ambien CR is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Ambien CR in a safe place to prevent misuse and abuse. Selling or giving away Ambien CR may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.