Zaleplon Oral capsule

What is this medicine?

ZALEPLON (ZAL e plon) is used to treat insomnia. This medicine helps you to fall asleep.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• history of a drug or alcohol abuse problem

• liver disease

• lung or breathing disease

• suicidal thoughts

• an unusual or allergic reaction to zaleplon, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to gradually reduce the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

• barbiturate medicines for inducing sleep or treating seizures

• carbamazepine

• certain medicines for allergies, like azatadine, clemastine, diphenhydramine

• certain medicines for depression, anxiety, or other emotional or psychiatric problems

• certain medicines for pain

• cimetidine

• erythromycin

• medicines for fungal infections like ketoconazole, fluconazole, or itraconazole

• other medicines given for sleep

• phenytoin

• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Talk to your doctor if you still have trouble sleeping.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again. You may not be able to remember things that you do in the hours after you take this medicine. Some people have reported driving, making phone calls, or preparing and eating food while asleep after taking sleep medicine. Take this medicine right before going to sleep. Tell your doctor if you are have any problems with your memory.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• depression, suicidal thoughts

• feeling faint or lightheaded

• hallucinations

• hostility, restlessness, excitability

• slurred speech

• staggering, tremors

• unusual activities while asleep like driving, eating, making phone calls

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• difficulty with coordination

• loss of memory

• nightmares

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.