When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to zaleplon, or if you have severe liver disease.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine just before going to bed or when you will have time to sleep for at least 4 hours.
• You should not use this medicine with a high-fat or heavy meal.
• This medicine is not for long-term use. Zaleplon should be used for no more than 10 days unless otherwise ordered by your doctor.
• If you have used this medicine every night for more than 1 week, do not suddenly stop using it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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 are also using carbamazepine (Tegretol®), cimetidine (Tagamet®), erythromycin (Ery-tab®), imipramine (Tofranil®), ketoconazole (Nizoral®), phenobarbital, phenytoin (Dilantin®), promethazine (Phenergan®), rifampin (Rifadin®), or thioridazine (Mellaril®).
• 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:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have mild liver disease, any breathing problems, or a history of depression, alcoholism, or drug abuse.
• Zaleplon also may cause temporary changes in your behavior, such as aggression, agitation, confusion, or strange behavior. Contact your doctor if you notice any of these signs while using this medicine.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you take this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. This medicine may also cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
• Sometimes these effects may last through the next day. Make sure you know how the medicine will affect you before you do any tasks that require you to be alert.
• 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.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Call your doctor if your symptoms do not improve or if they get worse.

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
• Changes in behavior or thinking.
• Depressed mood or thoughts of suicide.
• Diarrhea that may contain blood.
• Seeing, hearing, or feeling things that are not there.
• Swelling in your hands, ankles, or feet.
• Trouble breathing.

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

• Anxiety.
• Blurred vision or eye pain.
• Dizziness, drowsiness, headache, or lightheadedness.
• Loss of appetite.
• Loss of memory for the first few hours after using the medicine.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Stomach pain or nausea.
• Trouble with coordination or muscle stiffness.

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