MEDICATION GUIDE

Zaleplon Capsules USP   C-IV

(zal' e plon)

Read this Medication Guide before you start taking zaleplon capsules and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. You and your doctor should talk about zaleplon capsules when you start taking it and at regular checkups.

What is the most important information I should know about zaleplon capsules?

Zaleplon capsules may cause serious side effects including complex sleep behaviors that may cause serious injury and death.. After taking zaleplon capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zaleplon capsules whether or not you drink alcohol or take other medicines that make you sleepy.

Reported activities include:

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driving a car ("sleep-driving")

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making and eating food

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talking on the phone

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having sex

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sleep-walking

Important:

1. Take zaleplon capsules exactly as prescribed

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Do not take more zaleplon capsules than prescribed.

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Take zaleplon capsules right before you get in bed, not sooner.

2. Do not take zaleplon capsules if you:

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have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking zaleplon capsules

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drink alcohol

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take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zaleplon capsules with your other medicines

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cannot get a full night's sleep

3. Stop taking zaleplon capsules and call your doctor right away if you find out that you have done any of the above activities after taking zaleplon capsules.

What are zaleplon capsules?

Zaleplon capsules are a sedative-hypnotic (sleep) medicine. Zaleplon capsules are used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon does not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.

Zaleplon capsules are not for children.