Ambien CR Extended-Release Tablets

Treating insomnia (trouble falling asleep or staying asleep).

Ambien CR Extended-Release Tablets is a sedative-hypnotic, or sleep medicine. It works by helping to increase certain natural chemicals in the brain that cause sleep. Ambien CR is a dual-layer tablet - the first layer is designed to dissolve quickly to help you get to sleep and the second layer is designed to dissolve slowly, to help you stay asleep.

• you are allergic to any ingredient in Ambien CR Extended-Release Tablets
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Ambien CR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], sleep apnea), myasthenia gravis, metabolism problems, heart or blood pressure problems, or very poor health
• if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or addiction
• if you are a child or teenager with a history of attention deficit hyperactivity disorder (ADHD)

Some MEDICINES MAY INTERACT with Ambien CR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Ketoconazole, HIV protease inhibitors (eg, ritonavir), or sodium oxybate (GHB) because they may increase the risk of Ambien CR Extended-Release Tablets's side effects
• Rifampin because it may decrease Ambien CR Extended-Release Tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ambien CR Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use Ambien CR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ambien CR Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ambien CR Extended-Release Tablets refilled.
• Take Ambien CR Extended-Release Tablets by mouth on an empty stomach at least 2 hours after a meal.
• Swallow Ambien CR Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Ambien CR Extended-Release Tablets works very quickly; use Ambien CR Extended-Release Tablets right before going to sleep.
• Use Ambien CR Extended-Release Tablets only when you are able to get a full night's sleep (7 to 8 hours).
• If you miss a dose of Ambien CR Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your total daily dose in any 24-hour period.

Ask your health care provider any questions you may have about how to use Ambien CR Extended-Release Tablets.

• Ambien CR Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambien CR Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ambien CR Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• When you first start taking Ambien CR Extended-Release Tablets, it may have a "carryover" effect on you the next day. Use extreme care while doing anything that requires complete alertness (eg, driving a car).
• If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
• Sleep medicines may cause a special type of memory loss or amnesia. To prevent memory problems, be sure to use Ambien CR Extended-Release Tablets only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your health care provider if you think you are having memory problems.
• Some patients taking Ambien CR Extended-Release Tablets have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Ambien CR Extended-Release Tablets. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use these medicine. Tell your doctor right away if such an event happens to you.
• Use Ambien CR Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness or drowsiness.
• Ambien CR Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. Children may be more sensitive to Ambien CR Extended-Release Tablets's side effects, especially dizziness, headache, and hallucinations.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ambien CR Extended-Release Tablets while you are pregnant. Ambien CR Extended-Release Tablets may cause prolonged sleep in the fetus when used during the last weeks of pregnancy. Ambien CR Extended-Release Tablets is found in breast milk. If you are or will be breast-feeding while you take Ambien CR Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Ambien CR Extended-Release Tablets. This is known as DEPENDENCE or addiction. Be sure to tell your doctor if you have been dependent on alcohol, prescription medicines, or street drugs in the past.

If you stop taking Ambien CR Extended-Release Tablets suddenly, you may have WITHDRAWAL symptoms. These may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. If you take Ambien CR Extended-Release Tablets for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; muscle aches; nausea; nose or throat irritation; sluggishness; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; difficulty swallowing or breathing; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety, depression); severe dizziness; shortness of breath; suicidal thoughts or actions; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately. Symptoms may include severe drowsiness or coma.

Store Ambien CR Extended-Release Tablets at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Brief storage at temperatures up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ambien CR Extended-Release Tablets out of the reach of children and away from pets.

• If you have any questions about Ambien CR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Ambien CR Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Ambien CR Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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