ISSUE:FDAis advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with
BACKGROUND:Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.
If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:
Stop taking your insomnia medicine.
Contact your health care professional right away if you.
Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:
Although rare, the behaviors caused by these medicines have led to serious injuries or death.
To discontinue taking these medicines if they experience an episode of complex sleep behavior.
Zaleplon is used on a short-term basis to treat insomnia (difficulty falling asleep). Zaleplon does not help you to stay asleep longer or decrease the number of times that you awaken during the night. Zaleplon is in a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.
HOW should this medicine be used?
Zaleplon comes as a capsule to take by mouth. It is usually taken as needed at bedtime or after trying unsuccessfully to fall asleep. Do not take zaleplon with or shortly after a heavy, high-fat meal. Zaleplon may not work well if it is taken with high fat foods. 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.
You will probably become very sleepy soon after you take zaleplon and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take zaleplon and to stay in bed for 7 to 8 hours. Do not take zaleplon if you will be unable to go to bed right away and remain asleep for 7 to 8 hours after taking the medication. If you continue to walk around after taking zaleplon, you may experience dizziness, lightheadedness, problems with memory and coordination, or hallucinations (seeing things or hearing voices that do not exist). If you get up too soon after taking zaleplon, you may experience memory problems.
You should be sleeping well within 7 to 10 days after you start taking zaleplon. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.
Zaleplon can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor.
Do not stop taking zaleplon without talking to your doctor. If you suddenly stop taking zaleplon, you may experience withdrawal symptoms such as unpleasant feelings, stomach and muscle cramps, vomiting, sweating, shakiness, and rarely, seizures. Your doctor will probably decrease your dose gradually.
You may have more difficulty falling asleep or staying asleep on the first few nights after you stop taking zaleplon than you did before you started taking the medication. This is normal and usually gets better without treatment after one or two nights.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with zaleplon and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking zaleplon,
tell your doctor and pharmacist if you are allergic to zaleplon, aspirin, any other medications, or tartrazine (a yellow dye in some processed foods and drugs). Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines such as diphenhydramine (Benadryl) or promethazine; barbiturates; cimetidine (Tagamet); cough and cold medicines;erythromycin; ibuprofen; imipramine (Tofranil); ketoconazole (Nizoral); medications for allergies such as diphenhydramine (Benadryl), depression, or mental illness; certain medications for seizures such as phenytoin (Dilantin), carbamazepine (Epitol, Tegretol, others), and phenobarbital; pain relievers; promethazine (Promethegan); rifampin (Rifadin, Rimactane); sedatives, other sleeping pills, thioridazine, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had depression, mental illness, seizures, lung disease or breathing problems, or kidney or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking zaleplon, call your doctor.
talk to your doctor about the risks and benefits of taking zaleplon if you are 65 years of age or older. Older adults should not usually take zaleplon because it is not as safe or effective as other medications that can be used to treat the same condition.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zaleplon.
you should know that this medication may make you drowsy during the daytime, may decrease your mental alertness, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Do not drive a car or operate machinery until you know how zaleplon affects you.
do not drink alcohol while you are taking zaleplon. Alcohol can make the side effects of zaleplon worse.
you should know that some people who took medications for sleep got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.
you should know that your mental health may change in unexpected ways while you are taking this medication. These changes may be caused by zaleplon or they may be caused by physical or mental illnesses that you already have or that you develop during your treatment. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Zaleplon should only be taken at bedtime. If you did not take zaleplon before you went to bed and you are unable to fall asleep, you may take zaleplon if you will be able to stay in bed for at least 8 hours afterward. Do not take a double dose of zaleplon to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Zaleplon may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
lack of coordination
numbness, burning, or tingling in the hands or feet
loss of appetite
sensitivity to noise
distorted sense of smell
painful menstrual periods
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
swelling of the face, throat, tongue, lips, or eyes
difficulty breathing or swallowing
Zaleplon may cause other side effects. Tell your doctor if you experience any unusual problems while you are taking this medication.
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 ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
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).
Keep zaleplon in a safe place so no one else can take it accidentally or on purpose. Keep track of how many capsules are left so you will know if any are missing.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
problems with coordination
slow or difficult breathing
coma (loss of consciousness for a period of time)
What OTHER INFORMATION should I know?
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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