Zaleplon (By mouth)

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

Introduction

Zaleplon (ZAL-e-plon)

Treats insomnia (having trouble falling asleep).

Brand Name(s)

Sonata

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule

• 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.
• 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. 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:

• If you do not remember until the next morning that you missed a dose of zaleplon the night before, skip the missed dose. Wait until that night to use your medicine.
• You should not use two 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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 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 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.

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.

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 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.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• If your symptoms do not improve or if they get worse, call your doctor.