What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine is for short-term periods of use. If sleep medicine is taken every night for a long time it may no longer help you to sleep. Your body can become dependent on this medicine, ask your doctor or health care professional if you still need to take it. However, if you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again. You may not be able to remember things that you do in the hours after you take this medicine. Some people have reported driving, making phone calls, or preparing and eating food while asleep after taking sleep medicine. Take this medicine right before going to sleep. Tell your doctor if you are have any problems with your memory.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• confusion
• depression
• feeling faint or lightheaded
• hallucinations
• memory loss
• mood changes, excitability or aggressive behavior
• muscle cramps
• problems with balance, speaking, walking
• suicidal thoughts
• tremors
• unusually weak or tired
• unusual activities while asleep like driving, eating, making phone calls

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness, drowsiness
• headache
• increased dreaming
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.