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Zaleplon

(zal' e plon)

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IMPORTANT WARNING:   Return to top

[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html.

Why is this medication prescribed?   Return to top

See the MedWatch notification at the beginning of the monograph.

Zaleplon is used for short-term treatment of insomnia to help you fall asleep.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?   Return to top

See the MedWatch notification at the beginning of the monograph.

Zaleplon comes as a capsule to take by mouth. It is usually taken once a day at bedtime or after going to bed if you cannot fall asleep. This medication is usually taken for 7-10 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zaleplon exactly as directed. Do not take zaleplon unless you will be able to sleep for at least 4 hours after taking the dose.

Zaleplon can be habit-forming; do not take a larger dose, take it more often, or take it for a longer period than your doctor tells you to. Do not stop taking zaleplon without talking to your doctor.

Zaleplon can lose its effectiveness if used for long periods of time. If you experience difficulty falling asleep, call your doctor.

What special precautions should I follow?   Return to top

See the MedWatch notification at the beginning of the monograph.

Before taking zaleplon,

What special dietary instructions should I follow?   Return to top

Do not take zaleplon with or right after a high-fat or heavy meal.

What should I do if I forget a dose?   Return to top

Do not take a missed dose when you remember it. Skip the missed dose and take the next dose at the regularly scheduled time.

What side effects can this medication cause?   Return to top

See the MedWatch notification at the beginning of the monograph.

Zaleplon may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

If you experience any of the following symptoms, call your doctor immediately:

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?   Return to top

See the MedWatch notification at the beginning of the monograph.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Zaleplon is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Sonata®

Last Revised - 04/01/2007
Last Reviewed - 08/01/2007


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