Zolpidem Extended-Release Tablets

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.

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow the tablets whole. 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 about the use of this medication in children. Special care may be needed.

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

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.

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

• Depression
• Frequently drink alcohol
• Liver disease
• Lung or breathing disease
• Myasthenia gravis
• Sleep apnea
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• Unusual sleep behaviors or activities you do not remember
• An unusual or allergic reaction to zolpidem, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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

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

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.

You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.

Plan to go to bed and stay in bed for a full night (7 to 8 hours) after you take this medication. You may still be drowsy the morning after taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce 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.