Zolpidem (By mouth)

Introduction

Zolpidem Tartrate (zole-PI-dem TAR-trate)

Treats insomnia (trouble sleeping).

Brand Name(s)

Ambien, Ambien CR, AmbienPAK, Sentrazolpidem PM-5, Gabazolpidem-5, Intermezzo, Edluar

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet, Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• Place the sublingual tablet under your tongue. Let it dissolve before you swallow it. Do not swallow the tablet whole.
• The regular tablet or extended-release tablet is usually taken just before bedtime, or when you are having trouble falling asleep. Only use this medicine if you are able to sleep or rest for 7 to 8 hours before you need to be active again.
• Check the time before you take Intermezzo®. Take it only if you have at least 4 hours to sleep before you plan to wake up.
• It is best to take this medicine on an empty stomach. It may take longer for this medicine to work if you take it just after a meal.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• Take this medicine when you need it to help you sleep, not on a fixed schedule. Never take 2 doses at the same time.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use itraconazole (Sporanox®), ketoconazole (Nizoral®), rifampin (Rifadin®, Rimactane®), or chlorpromazine. Tell your doctor if you take an antidepressant medicine, such as sertraline (Zoloft®), fluoxetine (Prozac®), or imipramine.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, myasthenia gravis (severe muscle weakness), or lung disease or breathing problems, including sleep apnea. Tell your doctor if you have ever abused alcohol or other drugs, or if you have a history of depression or mental illness.
• Tell your doctor if you develop any abnormal thoughts or behaviors. This includes aggressive behavior, confusion, hallucinations (seeing, hearing, or feeling things that are not there), worsening depression, suicidal thoughts, and unusual agitation or nervousness.
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that this has happened.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Call your doctor if you still have insomnia after using this medicine for 7 to 10 days.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Lightheadedness or fainting
• Seeing, hearing, or feeling things that are not really there
• Severe depression or thoughts of suicide
• Unusual or disturbing thoughts or behavior

If you notice these less serious side effects, talk with your doctor:

• Confusion, blurred vision, or problems with balance
• Dizziness
• Headache
• Memory loss

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088