Zaleplon

IMPORTANT WARNING:

Zaleplon may cause serious or possibly life-threatening sleep behaviors. Some people who took zaleplon got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, sleep-walked, or were involved in other activities while not fully awake. After they woke up, these people were unable to remember what they had done. These activities may occur with zaleplon whether or not you drink alcohol or also take other sleep medications. Tell your doctor if you have ever had an unusual sleep behavior while taking zaleplon. Be sure that your family or caregiver knows that these symptoms may be serious so they can call your doctor if any of these effects occur. Stop taking zaleplon and call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

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

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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking zaleplon,

• tell your doctor and pharmacist if you are allergic to zaleplon, aspirin, any other medications, tartrazine (a yellow dye in some processed foods and drugs), or any of the ingredients in zaleplon capsules. 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 while taking zaleplon. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..

• The following nonprescription products may interact with zaleplon: cimetidine, diphenhydramine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking zaleplon. Do not start any of these medications while taking zaleplon without discussing with your healthcare provider.

• 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.

• you should know that this medication may cause drowsiness, decreased mental alertness, prolonged reaction time, problems with coordination the day after you take it, blurry or double vision, 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. Your ability to drive or operate machinery the day after you take zaleplon may be impaired even if you feel fully awake. 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.

• 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.

• 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:

• drowsiness
• dizziness
• lightheadedness
• lack of coordination
• numbness, burning, or tingling in the hands or feet
• headache
• loss of appetite
• vision problems
• eye pain
• sensitivity to noise
• distorted sense of smell
• painful menstrual periods

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• rash
• itching
• hives
• swelling of the face, throat, tongue, lips, or eyes
• hoarseness
• 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 (https://www.fda.gov/Safety/MedWatch) 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. https://www.upandaway.org

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 (https://goo.gl/c4Rm4p) 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 https://www.poisonhelp.org/help. 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:

• drowsiness
• confusion
• problems with coordination
• floppy muscles
• 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.