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

Treats insomnia (trouble sleeping).

Brand Name(s):

Ambien, Ambien CR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine is not for long-term use.
• This medicine is usually taken just before bedtime, or when you are having trouble falling asleep. Do not take this medicine if you are not able to sleep or rest for 7 to 8 hours before you need to be active again.
• It is best to take this medicine on an empty stomach. Do not take this medicine with food or right after a meal because it may not work as well.
• Do not take this medicine if you have drank alcohol the same evening or before bedtime.
• Swallow the capsule whole. Do not open, crush, or chew it.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Use this medicine only when you cannot sleep. You do not need to take it on a schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how zolpidem works. Tell your doctor if you are using chlorpromazine, ciprofloxacin, fluoxetine, fluvoxamine, imipramine, ketoconazole, rifampin, sertraline, or St John's wort.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Using this medicine during the last 3 months of your pregnancy (third trimester) can harm your newborn baby. Tell your doctor right away if you are pregnant or if you think you have become pregnant while using this medicine.
• Do not breastfeed while you are using this medicine. You should pump and throw away breast milk for 23 hours after using this medicine.
• Tell your doctor if you have kidney disease, liver disease, lung disease (including COPD), breathing problems (including sleep apnea), or myasthenia gravis. Tell your doctor if you have a history of alcohol or drug addiction, depression, or mental health problems.
• This medicine may cause the following problems:
  • Sleep-related behaviors (including sleep-driving, sleep-walking, or having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake)
  • Unusual thoughts or behavior
  • Respiratory depression (serious breathing problem that can be life-threatening), when used with narcotic pain medicines
• This medicine may cause dizziness, drowsiness, especially first thing the next morning. It may also cause decreased alertness or trouble with thinking or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Call your doctor if you still have trouble sleeping after you take this medicine for 7 to 10 days.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Changes in mood or behavior, depression, nervousness, thoughts or attempts of hurting yourself
• Memory loss
• Seeing, hearing, or feeling things that are not there
• Severe confusion, drowsiness, muscle weakness
• Unusual tiredness or weakness

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

• Daytime drowsiness, headache

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