This medicine is a benzodiazepine used to treat sleep disorders. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medicine by mouth 15 to 30 minutes before bedtime. Do not take it with meals or right after a meal. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If you no longer have time for a full night's sleep or you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. DO NOT TAKE 2 doses at once.
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 also taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking methadone, clozapine, anticonvulsants (eg, phenobarbital), antihistamines (eg, diphenhydramine), disulfiram, HIV protease inhibitors (eg, ritonavir), nefazodone, omeprazole, medicines for mental or mood problems, rifampin, hydantoins (eg, phenytoin), bupropion, or efavirenz. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including if you have a history of mental or mood problems (eg, depression); suicidal thoughts or behaviors; liver or kidney problems; the blood disease porphyria; glaucoma, increased eye pressure, or risk factors for glaucoma; lung or breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema); myasthenia gravis; very poor health; allergies; pregnancy; or breast-feeding. Tell your doctor if you have or have ever had alcoholism or substance abuse or dependence, or if you consume more than 3 alcohol-containing drinks per day. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant or have known or suspected sleep apnea (trouble breathing while asleep). Use of this medicine in children under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while using this medicine include clumsiness or unsteadiness, daytime drowsiness, dizziness, dry mouth, fatigue, headache, lightheadedness, sluggishness, or stomach upset. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; anxiety; behavior changes; confusion; decreased coordination; decreased urination; hallucinations; irregular heartbeat; loss of bladder control; memory problems (eg, memory loss); menstrual changes; mental or mood changes (eg, aggression, agitation, depression); muscle spasms or weakness; new or worsening trouble sleeping; slurred speech or other speech changes; suicidal thoughts or actions; vision changes; or yellowing of the skin or eyes. 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; 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 clumsiness, coma, confusion, difficult or slow breathing, dizziness, drowsiness leading to unresponsiveness or coma, lightheadedness especially upon standing, or loss of consciousness.
If your symptoms do not improve within 7 to 10 days or if they become 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.