Learn more about usage, cautions, and possible side effects .
Chemical Name: RAMELTEON (ra-MEL-tee-on)
This medicine in a melatonin agonist used for treating insomnia (trouble falling asleep). It may also be used for other conditions as determined by your doctor.
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 fluvoxamine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking imidazoles (eg, ketoconazole) or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver problems, heart disease, difficulty breathing while sleeping, severe lung problems (eg, chronic obstructive pulmonary disease [COPD]), mental or mood problems (eg, depression), allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of alcohol abuse or suicidal thoughts or behaviors. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems. Use of this medicine in CHILDREN 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 using this medicine.
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. DO NOT TAKE THIS MEDICINE WITH OR IMMEDIATELY AFTER A HIGH-FAT MEAL. TAKE THIS MEDICINE by mouth within 30 minutes prior to going to bed. USE THIS MEDICINE ONLY WHEN YOU ARE ABLE TO GET A FULL NIGHT'S SLEEP (7 to 8 hours). STORE THIS MEDICINE at 77 degrees F (25 degrees C) away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. 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.
DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking this medicine. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. AVOID DRINKING ALCOHOL OR TAKING OTHER MEDICINES that cause drowsiness (eg, sedatives, tranquilizers) while taking this medicine. This medicine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. WHEN YOU FIRST START TAKING THIS MEDICINE, it may have a "carryover" effect on you the next day. Use extreme care while doing anything that requires complete alertness (eg, driving a car). SOME PATIENTS TAKING THIS MEDICINE have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of this medicine. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use this medicine. Tell your doctor right away if such an event happens to you. IF YOUR INSOMNIA WORSENS OR IS NOT BETTER within 7 to 10 days, check with your doctor. This may mean there is another condition causing your sleep problems BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea; dizziness; drowsiness; fatigue; nausea; or tiredness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience absence of a menstrual cycle; decreased sex drive; difficulty swallowing or breathing; fever; hallucinations; headache; irregular heartbeat; memory problems; mental or mood changes (eg, abnormal thinking, agitation, anxiety, behavior changes, new or worsening depression); muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; shortness of breath; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; vomiting; or worsening of sleeplessness. 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. 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.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
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. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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