ZALEPLON ORAL (SONATA) BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP LIVER PROBLEMS; DEPRESSION. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine on an EMPTY stomach, 1 hour before or 2 hours after the ingestion of food. * TAKE immediately before bedtime, or after you have gone to bed and cannot fall asleep. * Use this medication only when you can get at least 4 hours of sleep. * DO NOT EXCEED recommended dosage; excessive use may lead to adverse effects or loss of effectiveness. Do not adjust the dose unless instructed. * If this medicine is used as an aid to sleep, do not use for longer than prescribed as it appears to lose its effectiveness. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * AVOID concurrent use of alcohol or other CNS depressants as it may intensify the drowsiness, dizziness, or lightheadedness effect of this medicine. * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Behavior problems. Other Common Side Effects: TOP Indigestion; Headache; Dizziness; Stomach discomfort or pain; Drowsiness; Visual disturbances; Increased sensitivity to sunlight; Swelling of the extremities; Decreased appetite; Loss of memory; Bowel inflammation; Difficult and painful menstruation; Ear pain; Nose bleeding; Hallucinations; Muscle pain; Sleepiness; Shakiness; Vertigo; Muscle weakness. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved