Edluar SL

Zolpidem is used for short-term treatment of sleep problems (insomnia). It may help you fall asleep faster, stay asleep longer, and reduce the number of times you awaken during the night. Zolpidem belongs to a class of drugs called sedatives/hypnotics. It acts on your brain to produce a calming effect.

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, consult your doctor or pharmacist.

Take this medication by mouth without food immediately before bedtime, or as directed by your doctor. Do not take this medication with or right after a meal since it may take longer for the drug to work. Place one tablet under the tongue, allowing it to dissolve. Do not chew or swallow the tablet. Do not eat or drink while the tablet is dissolving in your mouth.

Do not take a dose of this medication unless you have time for a full night's sleep that lasts at least 7 to 8 hours.

Dosage is based on your medical condition, age, and response to treatment. Do not take more than 10 milligrams each day.

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, or 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 immediately.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and it is normal. It will usually go away after 1 to 2 nights. If this effect continues, contact your doctor.

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.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed.

Tell your doctor if your insomnia does not improve or if it worsens after 7 to 10 days.

Dizziness, headache, dry mouth, or diarrhea may occur. If any of these effects persist or worsen, 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 immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, mental/mood changes (such as confusion, depression, anxiety, aggressive behavior, hallucinations).

Some people who take sleep medications have reported getting out of bed and sleepwalking, driving, eating, talking on the phone, or having sex while not fully awake. Often they do not remember these activities. 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 immediately. 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, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood problems (such as depression), use/abuse of drugs/alcohol.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness and excessive drowsiness.

During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative/hypnotic drugs near the time of delivery may have undesirable effects such as withdrawal symptoms. Discuss the risks and benefits with your doctor.

A small amount of this medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: 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), HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for anxiety (such as alprazolam, diazepam), muscle relaxants, and narcotic pain relievers (such as codeine).

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.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include slow/shallow breathing, loss of consciousness.

Do not share this medication with others. It is against the law.

Lifestyle changes that can help you get to sleep include reducing stress, doing relaxation exercises, avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

Not applicable.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.