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|Zaleplon

Zaleplon

Zaleplon is used for:

Short-term treatment of insomnia.

Zaleplon is a hypnotic agent. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Zaleplon if:

• you are allergic to any ingredient in Zaleplon
• you are taking sodium oxybate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zaleplon :

Some medical conditions may interact with Zaleplon . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, especially tartrazine dye or aspirin
• if you have a history of depression or other mental illness, alcohol or drug abuse, or are debilitated
• if you have severe kidney or liver problems or a breathing disorder

Some MEDICINES MAY INTERACT with Zaleplon . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine,sodium oxybate, and alcohol because an increase in sleep duration may occur
• Carbamazepine, phenobarbital, phenytoin, or rifampin because the effectiveness of Zaleplon may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zaleplon may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zaleplon :

Use Zaleplon as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zaleplon may be taken with food or on an empty stomach.
• Do not take Zaleplon with or right after a high-fat or heavy meal. Doing so may delay when the medicine will begin to work.
• Zaleplon works very quickly. It should be taken immediately before going to bed or after you have gone to bed and are having trouble falling asleep.
• Do not take Zaleplon unless you will be able to get 4 or more hours of sleep before you must be active again.
• If you miss a dose of Zaleplon , take it when you remember if you are still able to get at least 4 hours of sleep. If you are no longer able to get at least 4 hours of sleep when you remember, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Zaleplon can be habit-forming. DEPENDENCE or "addiction" may occur. Stomach and muscle cramps, vomiting, sweating, shakiness, and, rarely, seizures may occur if Zaleplon is suddenly stopped. Withdrawal should be gradual.

Ask your health care provider any questions you may have about how to use Zaleplon .

Important safety information:

• Zaleplon may cause dizziness, drowsiness, or changes in vision. Use caution while driving or performing other tasks requiring mental alertness, coordination, and dexterity.
• Continue to use caution the morning after taking Zaleplon . Using Zaleplon alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Zaleplon may cause sensitivity to sunlight. Avoid prolonged exposure to the sun and other ultraviolet (UV) light (eg, sunlamps). Use sunscreens and wear protective clothing until tolerance is determined.
• Zaleplon will add to the effects of alcohol and other depressants. Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Zaleplon .
• Taking Zaleplon while still up and about may cause clumsiness, dizziness, hallucinations, lightheadedness, or memory loss.
• Notify your dentist or doctor that you are taking Zaleplon before you have any dental work or surgery.
• Some of these products may contain the dye tartrazine (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. Consult your doctor or pharmacist.
• Do not exceed the recommended dose or take Zaleplon for longer than prescribed. Exceeding the recommended dose or taking Zaleplon for longer than prescribed may be habit-forming.
• You may experience trouble sleeping for 1 to 2 nights after you stop taking Zaleplon . If it continues, contact your doctor.
• Caution is advised when using Zaleplon in the ELDERLY, as they may be more sensitive to the effects of Zaleplon .
• Use Zaleplon with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Zaleplon during pregnancy. Zaleplon is excreted in breast milk. Do not breast-feed while taking Zaleplon .

Possible side effects of Zaleplon :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; decreased sensitivity to touch; dizziness; drowsiness; incoordination; lightheadedness; muscle pain; short-term memory loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; agitation; bizarre behavior; changes in personality, mood, or behavior; daytime drowsiness; hallucinations; memory loss; suicidal thoughts; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; confusion; depression; drowsiness; lethargy; loss of coordination; loss of consciousness; low blood pressure; slow, shallow breathing; sluggishness.

Store between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Protect from light, moisture, and heat. Do not store in the bathroom. Keep Zaleplon out of the reach of children and away from pets.

General information:

• If you have any questions about Zaleplon , please talk with your doctor, pharmacist, or other health care provider.
• Zaleplon is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve in 7 to 10 days or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Zaleplon . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.