AMBIEN CR® (ām'bē-ən see ahr)
extended-release tablets, for oral use, C-IV
What is the most important information I should know about AMBIEN CR?
AMBIEN CR may cause serious side effects, including:
Complex sleep behaviors. 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. These activities may happen with AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking AMBIEN CR have reported:
Stop taking ABMIEN CR and tell your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN CR.
- making and eating food
- talking on the phone
- having sex
|What is AMBIEN CR?
AMBIEN CR is a prescription sleep medicine used for the treatment of adults who have trouble falling asleep or staying asleep (insomnia).
- It is not known if AMBIEN CR is safe and effective in children under the age of 18 years. AMBIEN CR is not recommended for use in children under the age of 18 years.
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 protect it from theft. Never give your AMBIEN CR to anyone else because it can cause death or harm them. Selling or giving away this medicine is against the law.
|Do not take AMBIEN CR if you:
Before taking AMBIEN CR, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- have a history of depression, mental illness, or suicidal thoughts or actions
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have a lung disease or breathing problems
- have sleep apnea
- have myasthenia gravis
- are pregnant or plan to become pregnant. Taking AMBIEN CR in the third trimester of pregnancy may harm your unborn baby.
- Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with AMBIEN CR.
- Babies born to mothers who take AMBIEN CR during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone).
- are breastfeeding or plan to breastfeed. AMBIEN CR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take AMBIEN CR.
AMBIEN CR and other medicines can interact with each other causing serious side effects. AMBIEN CR may affect the way other medicines work, and other medicines may affect how AMBIEN CR works.
Especially tell your healthcare provider if you:
You can ask your pharmacist for a list of medicines that interact with AMBIEN CR.
- take benzodiazepines
- take opioids as it may increase the risk of breathing problems (respiratory depression).
- take tricyclic antidepressants
- take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines)
- drink alcohol
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
|How should I take AMBIEN CR?
Take AMBIEN CR exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think AMBIEN CR is not working for you.
AMBIEN CR is for short-term use only. Treatment with AMBIEN CR should be as short as possible because the risk of dependence increases the longer you are being treated.
- Take 1 AMBIEN CR tablet a night right before bedtime.
Do not take AMBIEN CR if you are not able to stay in bed a full night (7 to 8 hours) before you must be active again.
- You should not take AMBIEN CR with or right after a meal. AMBIEN CR may help you fall asleep faster if you take it on an empty stomach.
Do not take AMBIEN CR if you drank alcohol that evening or before bed.
- Swallow AMBIEN CR tablets whole. Do not divide, crush, or chew AMBIEN CR tablets. If you cannot swallow AMBIEN CR tablets whole, tell your healthcare provider. You may need a different medicine.
- Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.
- If you take too much AMBIEN CR, call your healthcare provider or go to the nearest hospital emergency room right away.
|What are the possible side effects of AMBIEN CR?
AMBIEN CR may cause serious side effects including:
The most common side effects of AMBIEN CR include headache and dizziness.
- See "What is the most important information I should know about AMBIEN CR?"
AMBIEN CR can make you sleepy or dizzy and can slow your thinking and motor skills. Next-day sleepiness is common, but can be serious. Because AMBIEN CR can make you sleepy or dizzy you are at a higher risk for falls.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how AMBIEN CR affects you.
- Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking AMBIEN CR without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, AMBIEN CR may make your sleepiness or dizziness much worse.
Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking AMBIEN CR.
Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion (delirium), acting strangely, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
Risk of suicide and worsening of depression. Worsening of depression, including suicidal thoughts and actions can happen during treatment with medicines like AMBIEN CR. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with AMBIEN CR.
Breathing problems. See "Before taking AMBIEN CR, tell your healthcare provider about all of your medical conditions, including if you:" Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with AMBIEN CR.
Problems with your nervous system caused by severe liver disease (hepatic encephalopathy).
Withdrawal symptoms. You may have withdrawal symptoms if you stop taking AMBIEN CR suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium). Talk to your healthcare provider about slowly stopping AMBIEN CR to avoid withdrawal symptoms.
These are not all the side effects of AMBIEN CR.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
|How should I store AMBIEN CR?
Keep AMBIEN CR and all medicines out of reach of children.
- Store AMBIEN CR between at room temperature between 68°F to 77°F (20°C to 25°C).
|General Information about the safe and effective use of AMBIEN CR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN CR for a condition for which it was not prescribed. Do not give AMBIEN CR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about AMBIEN CR that is written for healthcare professionals.
|What are the ingredients in AMBIEN CR?
Active Ingredient: zolpidem tartrate
The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide.
The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Ambien and Ambien CR are registered trademarks of Sanofi. ©2022 sanofi-aventis U.S. LLC
Other brands listed are the trademarks of their respective owners and are not trademarks of Sanofi.
For more information, go to www.ambiencr.com or call 1-800-633-1610.