Zolpidem Extended-Release Tablets

Generic Name: Zolpidem Extended-Release Tablets (ZOLE-pih-dem)
Brand Name: Ambien CR

Zolpidem Extended-Release Tablets is used for:

Treating insomnia (difficulty falling or staying asleep).

Zolpidem 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.

Do NOT use Zolpidem Extended-Release Tablets if:

you are allergic to any ingredient in Zolpidem 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.

Before using Zolpidem Extended-Release Tablets:

Some medical conditions may interact with Zolpidem 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 a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, alcohol or drug abuse, liver problems, or breathing problems, especially when sleeping (eg, sleep apnea)

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

HIV protease inhibitors (eg, ritonavir) or sodium oxybate (GHB) because they may increase the risk of Zolpidem Extended-Release Tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zolpidem 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.

How to use Zolpidem Extended-Release Tablets:

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

An extra patient leaflet is available with Zolpidem Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
Take Zolpidem Extended-Release Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Zolpidem Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Zolpidem Extended-Release Tablets works very quickly; use Zolpidem Extended-Release Tablets right before going to sleep.
Use Zolpidem 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 Zolpidem 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 Zolpidem Extended-Release Tablets.

Important safety information:

Zolpidem Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zolpidem 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 Zolpidem 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 Zolpidem 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).
Sleep medicines may cause a special type of memory loss or "amnesia." To prevent memory problems, be sure to use this medicine 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 Zolpidem 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 Zolpidem 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 Zolpidem Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness or drowsiness.
Zolpidem 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 Zolpidem 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 Zolpidem Extended-Release Tablets while you are pregnant. Zolpidem Extended-Release Tablets may cause prolonged sleep in the fetus when used during the last weeks of pregnancy. Zolpidem Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Zolpidem Extended-Release Tablets.

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 Zolpidem 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 Zolpidem Extended-Release Tablets suddenly, you may have WITHDRAWAL symptoms. This 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 Zolpidem Extended-Release Tablets for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

Possible side effects of Zolpidem Extended-Release Tablets:

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.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include light coma; sleepiness.

Proper storage of Zolpidem Extended-Release Tablets:

Store Zolpidem 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 Zolpidem Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Zolpidem Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Zolpidem 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 Zolpidem 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.

Issue Date: August 6, 2008

Database Edition 08.3.1.002