ZOLPIDEM EXTENDED-RELEASE - ORAL

ZOLPIDEM EXTENDED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (ZOL-pi-dem)

COMMON BRAND NAME(S): Ambien CR

GENERIC NAME(S): zolpidem tartrate

Uses

USES: Zolpidem is used to treat a certain sleep problem (insomnia) in adults. It helps you fall asleep faster and stay asleep longer, so you can get a better night's sleep. It may also reduce the number of times you wake up during the night. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.


How to use ZOLPIDEM EXTENDED-RELEASE - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach as directed by your doctor, usually once a night. Since zolpidem works quickly, take it right before you get into bed. Do not take it with or after a meal because it will not work as quickly. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery. (See also Precautions section.) Dosage is based on your gender, age, medical condition, other medications you may be taking, and response to treatment. Do not increase your dose, take it more often, or use it for longer than prescribed. Do not take more than 12.5 milligrams a day. Women are usually prescribed a lower dose because the drug is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Tell your doctor if your condition persists after 7 to 10 days, or if it worsens. You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

Side Effects

SIDE EFFECTS: Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety). Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis). Do not drive, use machinery, or do any activities that require clear thinking after you take this medication and the next day. You may feel alert, but this medication may continue to affect your thinking, making such activities unsafe. This medication may also increase the risk of falls. You may also experience dizziness or blurred/double vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drink alcoholic beverages. Talk to your doctor if you are using marijuana. Children may be more sensitive to the side effects of this drug, especially dizziness and hallucinations. Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor. A small amount of this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: sodium oxybate. Other medications can affect the removal of zolpidem from your body, which may affect how zolpidem works. Examples include azole antifungals (such as ketoconazole), rifampin, St. John's Wort, among others. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zopiclone), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include slowed breathing or a deep sleep from which you cannot be awakened.

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Faq for ZOLPIDEM EXTENDED-RELEASE - ORAL

Zolpidem extended-release is a medication used for the treatment of insomnia, particularly trouble falling asleep.

Zolpidem extended-release works by affecting certain chemicals in the brain, which helps in promoting sleep and relaxation.

The recommended dosage for Zolpidem extended-release is 6.25 mg for women and 6.25 or 12.5 mg for men, taken once daily immediately before bedtime.

Common side effects of Zolpidem extended-release may include drowsiness, headaches, dizziness, and diarrhea.

Yes, Zolpidem extended-release has a potential for abuse and addiction, especially if used for a prolonged period or in higher doses than prescribed.

It is not recommended to drive or operate machinery after taking Zolpidem extended-release, as it may impair your ability to function properly.

If you miss a dose, do not take an extra dose to make up for it. Simply continue with your regular dosing schedule the following night.

It is not recommended to consume alcohol while taking Zolpidem extended-release, as it can increase the risk of side effects and impair your coordination and judgment.

Zolpidem extended-release should only be taken for a short period, usually for 1 to 2 weeks. Long-term use may lead to dependence and tolerance.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.