This medicine is a sedative-hypnotic (sleep medicine) used for short-term treatment of insomnia (trouble falling asleep).
Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE on an empty stomach at least 2 hours after a meal. This medicine works very quickly; use this medicine right before going to sleep. Use this medicine only when you are able to get a full night's sleep (7 to 8 hours). STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, and light. Do not store in the bathroom. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once. Do not take more than your total daily dose in any 24-hour period.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking ketoconazole, HIV protease inhibitors (eg, ritonavir), or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including kidney or liver problems, lung or breathing problems (eg, chronic obstructive pulmonary disease / COPD, sleep apnea), myasthenia gravis, metabolism problems, heart or blood pressure problems, very poor health, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or addiction. This medicine should not be used in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed. Children may be more sensitive to this medicine's side effects, especially dizziness, headache, and hallucinations. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea; dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; nausea; nose or throat irritation; sluggishness; stomach upset; or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; difficulty swallowing or breathing; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety); new or worsening depression; severe dizziness; shortness of breath; suicidal thoughts or actions; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; throat closing; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe drowsiness or coma.
THIS MEDICINE IS USUALLY USED ONLY FOR A SHORT PERIOD OF TIME. If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.