This medicine is a tricyclic sleep medicine used to treat insomnia (trouble sleeping) in patients who have trouble staying asleep. It may also be used for 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 at least 3 hours after your last meal. Take it by mouth within 30 minutes before bedtime. After taking this medicine, limit your activities to those needed to prepare for bed. 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. KEEP THIS MEDICINE out of the reach of children and away from pets. USE THIS MEDICINE only when you are able to get a full night's sleep (7 to 8 hours). IF YOU MISS a dose of this medicine and you no longer have time for a full night's sleep, skip the missed dose and go back to your regular dosing schedule. Do not take the dose in the morning. 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 have taken linezolid or a monoamine oxidase inhibitor (eg, phenelzine, furazolidone) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking antiarrhythmics (eg, flecainide, propafenone, quinidine), anticoagulants (eg, warfarin), antifungal medicines (eg, fluconazole, terbinafine), arsenic, astemizole, bepridil, carbamazepine, chloroquine, cimetidine, cisapride, clonidine, domperidone, guanadrel, guanethidine, guanfacine, halofantrine, ibutilide, iloperidone, macrolide antibiotics (eg, erythromycin), maprotiline, methadone, mibefradil, certain nausea medicines (eg, dolasetron), paliperidone, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, sertraline), sulfonylureas (eg, tolazamide), sympathomimetics (eg, formoterol, pseudoephedrine), terfenadine, tetrabenazine, tramadol, tyrosine kinase inhibitors (eg, nilotinib), ziprasidone, or a medicine that contains methylene blue. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of glaucoma, kidney or liver problems, trouble breathing while asleep (sleep apnea), trouble urinating, mental or mood problems (eg, depression), suicidal thoughts or behaviors, alcohol or substance abuse or dependence, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have untreated narrow angle glaucoma or severe trouble urinating. 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 dizziness, drowsiness, or nausea. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; behavior changes; confusion; fainting; fever, chills, or sore throat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety, depression); panic attacks; severe headache or dizziness; suicidal thoughts or actions; unusual bleeding or bruising; or worsening trouble sleeping. 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; or swelling of the mouth, face, lips, or tongue. 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 agitation, confusion, dry mouth, enlarged pupils, fast or irregular heartbeat, flushing, hallucinations, loss of consciousness, numbness or tingling, seizures, severe dizziness, trouble urinating, uncontrolled muscle movements, or unusual hair loss.
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.