Zaleplon (patient information)

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• Zaleplon#Patient Counseling Information

IMPORTANT WARNING:

[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

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

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

See the MedWatch notification at the beginning of the monograph.

Before taking zaleplon

• tell your doctor and pharmacist if you are allergic to zaleplon, aspirin, tartarzine (a yellow dye in some processed foods and drugs), or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially allergy medications; antihistamines; barbiturates; cimetidine (Tagamet); cold medicines; imipramine (Tofranil); medications for depression; medications for seizures such as phenytoin (Dilantin), carbamazepine (Eptitol, Tegretol, others), and phenobarbital (Solfoton); pain relievers; rifampin (Rifadin, Rimactane); thioridazine (Mellaril); tranquilizers; and vitamins and herbal products.
• tell your doctor if you have or have ever had kidney or liver disease, a history of alcohol or drug abuse or depression, asthma, breathing problems, or allergies.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking zaleplon, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zaleplon.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how zaleplon will affect you.
• remember that alcohol can add to the drowsiness caused by this drug.

What special dietary instructions should I follow

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

What should I do if I forget a dose

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

Side Effects

See the MedWatch notification at the beginning of the monograph.

Mild side effects

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

• drowsiness
• dizziness
• lightheadedness
• lack of coordination
• headache
• constipation
• dry mouth
• muscle aches

Severe side effects

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

• skin rash
• itching
• fast or irregular heartbeat
• chest pain
• difficulty breathing
• fever
• behavior changes or acting differently
• mental confusion
• abnormal thinking or dreams
• hallucinations
• depression
• worsening of insomnia
• problems with memory

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/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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

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

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.

Brand names

• Sonata®