Zolpidem extended-release tablets

Pronunciation

Generic Name: zolpidem (zole-PI-dem)
Brand Name: Ambien CR

Zolpidem extended-release tablets is used for:

Treating insomnia (trouble falling asleep 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 or to any other medicine that has zolpidem in it
  • you are taking another medicine to help you sleep, including any other medicine that has zolpidem in it
  • you are taking sodium oxybate (GHB)

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

Slideshow: Need To Catch Some Shut-Eye? Tips on Getting the Sleep You Need

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 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 zolpidem extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Benzodiazepines (eg, diazepam), chlorpromazine, HIV protease inhibitors (eg, ritonavir), ketoconazole, narcotic pain medicines (eg, hydrocodone, codeine), perampanel, sertraline, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline, imipramine) because they may increase the risk of zolpidem extended-release tablets's side effects
  • Rifampin because it may decrease zolpidem extended-release tablets's effectiveness

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.

  • Zolpidem extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get zolpidem extended-release tablets refilled.
  • Take zolpidem extended-release tablets by mouth on an empty stomach at least 2 hours after a meal.
  • 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 take zolpidem extended-release tablets if you drink alcohol that day or before bed, or if you 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.
  • Zolpidem extended-release tablets may cause a "carryover" effect on you the day after you take it. The risk may be increased if you take it with less than a full night's sleep (7 to 8 hours), if you take more than the recommended dose, or if you take it with certain other medicines. Do not drive or perform other tasks where you need to think clearly the day after you take zolpidem extended-release tablets. Discuss any questions or concerns with your doctor.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
  • 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 think you may be 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 or severe breathing problems in the newborn if you take it during the last weeks of pregnancy, especially if you take it with certain other medicines. Zolpidem extended-release tablets is found in breast milk. If you are or will be breast-feeding while you take zolpidem 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 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. 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 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; stomach upset; tiredness; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, eyes, throat, or tongue; throat closing; unusual hoarseness); abnormal thinking; behavior changes; breathing problems; chest pain; confusion; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety); new or worsening depression; severe dizziness; severe or persistent nausea or vomiting; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

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

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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take zolpidem extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about zolpidem extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to zolpidem extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using zolpidem extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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