tablets, for oral use, C-IV
|What is the most important information I should know about AMBIEN?
AMBIEN may cause serious side effects, including:
Complex sleep behaviors. After taking AMBIEN, 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 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 have reported:
Stop taking ABMIEN and tell your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN.
- making and eating food
- talking on the phone
- having sex
|What is AMBIEN?
AMBIEN is a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia).
- It is not known if AMBIEN is safe and effective in children under the age of 18 years. AMBIEN is not recommended for use in children under the age of 18 years.
AMBIEN is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep AMBIEN in a safe place to protect it from theft. Never give your AMBIEN to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.
|Do not take AMBIEN if you:
|Before taking AMBIEN, 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. AMBIEN and other medicines can interact with each other causing serious side effects. AMBIEN may affect the way other medicines work, and other medicines may affect how AMBIEN works.
- 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 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.
- Babies born to mothers who take AMBIEN 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 passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with AMBIEN.
Especially tell your healthcare provider if you:
You can ask your pharmacist for a list of medicines that interact with AMBIEN.
- 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?
Take AMBIEN exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think AMBIEN is not working for you.
AMBIEN is for short-term use only. Treatment with AMBIEN should be as short as possible because the risk of dependence increases the longer you are being treated.
- Take 1 AMBIEN tablet at night right before bedtime.
Do not take AMBIEN 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 with or right after a meal. AMBIEN may help you fall asleep faster if you take it on an empty stomach.
Do not take AMBIEN if you drank alcohol that evening or before bed.
- 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, call your healthcare provider or go to the nearest hospital emergency room right away.
|What are the possible side effects of AMBIEN?
AMBIEN may cause serious side effects, including:
The most common side effects of AMBIEN include sleepiness, dizziness, diarrhea, and grogginess or feeling like you have been drugged.
- See "What is the most important information I should know about AMBIEN?"
AMBIEN can make you sleepy or dizzy and can slow your thinking and motor skills. Because AMBIEN 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 affects you.
- Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking AMBIEN without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, AMBIEN 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 right away if you develop any of these symptoms during treatment with AMBIEN.
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. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with AMBIEN.
Breathing problems. See "Before taking AMBIEN, 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.
Problems with your nervous system caused by severe liver disease (hepatic encephalopathy).
Withdrawal symptoms. You may have withdrawal symptoms if you stop taking AMBIEN 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 to avoid withdrawal symptoms.
These are not all the side effects of AMBIEN.
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?
Keep AMBIEN and all medicines out of reach of children.
- Store AMBIEN at room temperature between 68°F to 77°F (20°C to 25°C).
|General Information about the safe and effective use of AMBIEN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN for a condition for which it was not prescribed. Do not give AMBIEN 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 that is written for healthcare professionals.
|What are the ingredients in AMBIEN?
Active Ingredient: zolpidem tartrate
Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 5 mg tablet contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
© 2022 sanofi-aventis U.S. LLC
For more information, go to WWW.AMBIEN.com or call 1-800-633-1610.