Zolpidem Extended-Release Tablets

What is this medication?

ZOLPIDEM (zole PI dem) treats insomnia. It helps you to get to sleep faster and stay asleep throughout the night. It is often used for a short period of time.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ambien CR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression
• History of drug abuse or addiction
• If you often drink alcohol
• Liver disease
• Lung or breathing disease
• Myasthenia gravis
• Sleep apnea
• Sleep-walking, driving, eating or other activity while not fully awake after taking a sleep medication
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to zolpidem, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, split, or chew the tablet before swallowing. It is better to take this medication on an empty stomach and only when you are ready for bed. Do not take your medication more often than directed. If you have been taking this medication for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your care team may want to gradually reduce the dose. Do not stop taking this medication on your own. Always follow your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain medications for anxiety or sleep
• Certain medications for depression, like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for seizures like phenobarbital, primidone
• Ciprofloxacin
• Dietary supplements for sleep, like valerian or kava kava
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Local anesthetics like lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medications are used every night for more than a few weeks, they may stop working. Talk to your care team if your insomnia worsens or is not better within 7 to 10 days.

After taking this medication, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Stop the medication and call your care team right away if you find out you have done any of these activities. Do not take this medication if you have used alcohol that evening. Do not take it if you have taken another medication for sleep. The risk of doing these sleep-related activities is higher.

Do not take this medication unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. Do not drive, use machinery, or do anything that needs mental alertness the day after you take this medication. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your care team if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

After you stop taking this medication, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, difficulty staying awake
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Unusual sleep behaviors or activities you do not remember such as driving, eating, or sexual activity

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Drowsiness the day after use
• Headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at controlled room temperature between 15 and 25 degrees C (59 and 77 degrees F).

This medication may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.