Zolpidem Capsules

What is this medication?

ZOLPIDEM (zole PI dem) treats insomnia. It helps you go to sleep faster and stay asleep through 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.

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

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

• Depression
• Frequently drink alcohol
• Kidney problems
• 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

How should I use this medication?

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 capsules whole. It is better to take this medication on an empty stomach and only when you are ready for bed. Do not take it 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.

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 right before going to sleep. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Sodium oxybate

This medication may also interact with the following:

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that relax muscles
• Opioids for pain or cough
• Other medications for sleep
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Some antihistamines
• Some medications for depression, such as amitriptyline, imipramine, sertraline, trazodone
• Some medications for seizures, such as phenobarbital or primidone
• Supplements, such as green tea, St. John's wort, valerian

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 you still have trouble sleeping.

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.

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.

This medication may worsen depression and cause thoughts of suicide. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you.

Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause withdrawal in a newborn.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• 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, trouble 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 these 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. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
• If other options are not available, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. Put it in the trash.

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.