Zaleplon
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Zaleplon
(zal' e plon)
(zal' e plon)
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Sonata
[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.
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.
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.
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:
- drowsiness
- dizziness
- lightheadedness
- lack of coordination
- headache
- constipation
- dry mouth
- muscle aches
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/index.html] or by phone [1-800-332-1088].
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.
Do not take zaleplon with or right after a high-fat or heavy meal.
Do not take a missed dose when you remember it. Skip the missed dose and take the next dose at the regularly scheduled time.
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 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.
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.
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