Zaleplon is a sedative that is used to treat insomnia. zaleplon causes relaxation to help you fall asleep and stay asleep.

Zaleplon may also be used for purposes not listed in this medication guide.

Some people using zaleplon have engaged in activity while not fully awake and later had no memory of it. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Zaleplon may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away zaleplon is against the law.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have several hours to dedicate to sleeping.

Zaleplon is for short-term use only. Do not take zaleplon for longer than 5 weeks without your doctor's advice.

Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

Do not stop using zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Insomnia symptoms may also return after you stop taking zaleplon, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking zaleplon.

Usual Adult Dose for Insomnia:

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 20 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia:

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 10 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

You should not use zaleplon if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don't remember.

Zaleplon is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• liver or kidney disease;

• a breathing disorder;

• depression, mental illness, or suicidal thoughts; or

• drug or alcohol addiction.

You should not take zaleplon if you are pregnant.

You should not breastfeed while using zaleplon.

The sedative effects of zaleplon may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zaleplon.

Since zaleplon is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medication if you do not have several hours to sleep before being active again.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zaleplon can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include severe drowsiness, confusion, loss of coordination, severe muscle weakness, weak or shallow breathing, fainting.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid taking zaleplon during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get the equivalent of a full night's sleep after taking zaleplon.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking zaleplon with food or right after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medicine.

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how zaleplon will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Zaleplon may cause serious side effects. Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;

• memory problems, unusual thoughts or behavior;

• thoughts of hurting yourself; or

• confusion, hallucinations (hearing or seeing things).

Common side effects of zaleplon may include:

• day-time drowsiness, dizziness, "hangover" feeling;

• feeling light-headed;

• problems with coordination; or

• numbness, tingling, or prickly feeling on your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using zaleplon with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.