Zaleplon

What is the most important information I should know about Zaleplon?

· Use caution when driving, operating machinery, or performing other hazardous activities. Zaleplon will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Zaleplon should be taken just before bedtime but you may experience some carryover effects (drowsiness, difficulty concentrating, memory loss) the next day.

· Do not take Zaleplon unless you are able to get 4 or more hours of sleep before you must be active again.

· Do not drink alcohol while taking Zaleplon. Alcohol will increase drowsiness and may increase dizziness while you are taking Zaleplon, which could be dangerous.

· Do not stop taking Zaleplon suddenly if you have been taking it for several days. This may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with Zaleplon.

 

What is Zaleplon?

· Zaleplon is in a class of drugs called sedative/hypnotics or sleep medications. Zaleplon affects chemicals in your brain that may become unbalanced and cause insomnia.

· Zaleplon is used to treat insomnia. Zaleplon is for short-term use only--usually only a few days to two weeks. Longer-term use must be monitored closely by your doctor.

· Zaleplon may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before taking Zaleplon?

· Before taking this medication, tell your doctor if you     ·an allergy or sensitivity to tartrazine;     ·have a history of drug or alcohol addiction;     ·are depressed;     ·have liver disease;     ·have sleep apnea (stopping breathing for short periods while asleep);     ·have asthma, bronchitis, emphysema, or another respiratory disease; or     ·have myasthenia gravis.

· You may not be able to take Zaleplon, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Zaleplon is in the FDA pregnancy category C. This means that it is unknown whether Zaleplon will harm an unborn baby. Do not take Zaleplon without first talking to your doctor if you are pregnant.

· Zaleplon passes into breast milk and may affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

· If you are over 60 years of age, you may be more likely to experience side effects from Zaleplon. You may require a lower dose of this medication.

 

How should I take Zaleplon?

· Take Zaleplon exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· Take each dose with a full glass of water.

· For best results, do not take Zaleplon with or immediately after a high-fat or heavy meal.

· Take Zaleplon just before you go to bed, or after you have gone to bed and are having trouble falling asleep. Zaleplon works very quickly. It will make you drowsy, and you could fall and hurt yourself if you take your dose before you are ready for sleep.

· Do not take more of this medication than is prescribed for you. Do not take more than one dose in a single night.

· Do not take Zaleplon unless you are able to get 4 or more hours of sleep before you must be active again.

· Do not stop taking Zaleplon suddenly if you have been taking it for several days. Stopping suddenly may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with Zaleplon.

· Store Zaleplon at room temperature away from moisture and heat.

 

What happens if I miss a dose?

· Since Zaleplon is usually taken only if you need it to help you sleep, missing a dose will not cause any problems. Take the missed dose only if you can be sure that you will get 4 or more hours of sleep after the dose. If you do not sleep for 4 or more full hours, you may experience carryover effects from Zaleplon after you wake up.

 

What happens if I overdose?

· Seek emergency medical attention.

· Symptoms of a Zaleplon overdose may include sleepiness, confusion, dizziness, low blood pressure, difficult or slow breathing, unconsciousness, and death.

 

What should I avoid while taking Zaleplon?

· Use caution when driving, operating machinery, or performing other hazardous activities. Zaleplon will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Zaleplon should be taken just before bedtime but you may experience some carryover effects (drowsiness, difficulty concentrating, memory loss) the next day.

· Do not drink alcohol while taking Zaleplon. Alcohol will increase drowsiness and may increase dizziness while you are taking Zaleplon, which could be dangerous.

· Zaleplon may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, other sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

 

What are the possible side effects of Zaleplon?

· If you experience any of the following serious side effects, stop taking Zaleplon and seek emergency medical attention:     ·an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, face, or tongue; or hives)     ·hallucinations (hearing or seeing things that are not real), abnormal behavior, or severe confusion.; or     ·suicidal thoughts.

· Other, less serious side effects may be more likely to occur. Continue to take Zaleplon and talk to your doctor if you experience     ·day-time drowsiness;     ·dizziness or lightheadedness;     ·unsteadiness and/or falls;     ·double vision or other vision problems;     ·agitation;     ·confusion;     ·headache;     ·nausea, vomiting, diarrhea, or abdominal pain;     ·depression;     ·muscle weakness;     ·tremor;     ·vivid or abnormal dreams; or     ·memory difficulties or amnesia.

· Zaleplon is habit forming. Stopping this medication suddenly can cause withdrawal effects such as mood changes, anxiety, and restlessness if you have taken it continuously for several weeks. Talk to your doctor about the safe use of this medication.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Zaleplon?

· Before taking Zaleplon, tell your doctor if you are taking any of the following medications:     ·rifampin (Rifadin, Rimactane);     ·phenytoin (Dilantin);     ·carbamazepine (Tegretol);     ·phenobarbital (Luminal, Solfoton); or     ·cimetidine (Tagamet, Tagamet HB).

· You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

· Zaleplon may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, other sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

· Drugs other than those listed here may also interact with Zaleplon. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

 

Where can I get more information?

· Your pharmacist has additional information about Zaleplon written for health professionals that you may read.