Zaleplon (ZAL-e-plon)

Treats insomnia.

Brand Name(s):

Sonata

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine just before going to bed or when you have trouble falling asleep. Do not take this medicine if you are not able to get a full night's sleep or rest (about 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.
• This medicine is not for long-term use.
• 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 zaleplon works. Tell your doctor if you are using carbamazepine, cimetidine, diphenhydramine, erythromycin, imipramine, ketoconazole, phenobarbital, phenytoin, promethazine, rifampin, or thioridazine.
• 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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung disease (including asthma, COPD), breathing problems (including sleep apnea), or a history of depression, mental health problems, or alcohol or drug abuse. Tell your doctor if you are allergic to tartrazine or sensitive to aspirin.
• This medicine may cause dizziness or drowsiness, especially first thing the next morning. It may also cause decreased alertness, trouble with thinking, or trouble with controlling body movements, This can 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 may cause unusual moods and behaviors. You may also do things while you are still asleep that you may not remember the next morning, including driving, eating, having sex, sleepwalking, or making phone calls. Tell your doctor right away if you have learned that this has happened.
• This medicine may also cause respiratory depression, a serious breathing problem that can be life-threatening.
• 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
• Anxiety, agitation, depression, nervousness, unusual moods or behavior, thoughts of hurting yourself
• Memory loss
• Seeing, hearing, or feeling things that are not there
• Severe confusion, drowsiness, muscle weakness
• Trouble breathing, blue lips, fingernails, or skin

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

• Headache, daytime drowsiness, dizziness
• Nausea, stomach pain

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