This medicine is a sedative or "sleeping medicine" used to treat sleeping problems (such as trouble falling asleep or trouble staying asleep during the night). 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 each time you receive this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. DO NOT TAKE this medicine with or immediately after a high-fat, heavy meal. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. This medicine works very quickly. TAKE THIS MEDICINE ONLY AT BEDTIME, either immediately before going to bed or after you have gone to bed. This will help to decrease the risk of falling and other side effects. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking 1 dose daily at bedtime, skip the missed dose. DO NOT take the dose in the morning or 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. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking antidepressants (eg, amitriptyline), antihistamines (eg, diphenhydramine, chlorpheniramine), azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, nelfinavir, ritonavir), lorazepam, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, olanzapine, perampanel, rifamycins (eg, rifampin), telithromycin, medicine for mental or mood disorders (eg, thioridazine, haloperidol), medicine for seizures (eg, phenytoin, carbamazepine, phenobarbital), or any medicine that may cause drowsiness. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of alcohol, drug, or other substance abuse or dependence; mental or mood problems (eg, depression); suicidal thoughts or behavior; lung or breathing problems; liver problems; allergies; pregnancy; or breast-feeding. TELL YOUR DOCTOR if you are very ill or have poor health. 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 taking this medicine include anxiety, common cold symptoms, decrease in sexual desire, decreased coordination, dizziness, drowsiness, dry mouth, headache, indigestion, lightheadedness, nervousness, or unpleasant taste. If they continue or are bothersome, check with your doctor. THIS MEDICINE may cause a special type of memory loss or amnesia. To avoid memory problems, be sure to use this medicine only when you are able to get a full night's sleep (8 hours) before you need to be active again. Contact your doctor if you think you are having memory problems. IF YOU OR YOUR FAMILY notice any mental, mood, or behavior changes (eg, more outgoing or aggressive, confusion, agitation, depression), or if you have unusual or disturbing thoughts, contact your doctor immediately. CONTACT YOUR DOCTOR IMMEDIATELY if you experience breast enlargement (in males); chest pain; confusion; fever, chills, or persistent sore throat; hallucinations; increased or painful urination; painful menstrual periods; painful or burning sensation; severe headache; sudden or severe nausea or vomiting; suicidal thoughts or behavior; or swelling of your hands or feet. 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. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. 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.
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. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.