Rozerem Safety Questions, Rozerem Answers
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Rozerem Safety Reports
Total Rozerem reports: 1152.Rozerem FDA safety alerts: 2007 .
Reported deaths: 5 Reported hospitalizations: 33.
Take Rozerem Side Effects Survey or Share Your Rozerem Story.
Reported Rozerem Side Effects: initial insomnia, middle insomnia, poor quality sleep, somnolence, insomnia, feeling abnormal, nightmare, fatigue, abnormal dreams, nausea, headache.
Rozerem Usage.
Showing 1-50 of 1152 Next >
Rozerem Side Effects Report #5321609-7Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 26, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321610-3
ROZEREM problem was reported by a Physician from UNITED STATES on Jan 08, 2007. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321611-5
Physician from UNITED STATES reported ROZEREM problem on Oct 26, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: somnolence. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321612-7
ROZEREM problem was reported by a Physician from UNITED STATES on Jan 10, 2007. Male patient, 30 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: paranoia. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321615-2
Physician from UNITED STATES reported ROZEREM problem on Jan 10, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: paranoia. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321616-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 27, 2006. Female patient, 59 years of age, weighting 140.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LIPITOR, AMITRIPTYLINE. Patient recovered.
Rozerem Side Effects Report #5321617-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 17, 2006. Female patient, 52 years of age, weighting 113.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with FEMHRT, FOSAMAX. Patient recovered.
Rozerem Side Effects Report #5321618-8
ROZEREM problem was reported by a Physician from UNITED STATES on Jan 10, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: rash. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321621-8
Physician from UNITED STATES reported ROZEREM problem on Jan 03, 2007. Female patient, 74 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: endocrine ophthalmopathy, rash morbilliform, urticaria. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with PAXIL, LEVOXYL, ASPIRIN, PRILOSEC, PREMARIN. Patient recovered.
Rozerem Side Effects Report #5321623-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 02, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, poor quality sleep, somnolence. ROZEREM dosage: 8 MG, ONCE, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321627-9
Physician from UNITED STATES reported ROZEREM problem on Dec 15, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: palpitations. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321631-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 21, 2006. Male patient, 72 years of age, weighting 197.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, stomach discomfort. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with COREG, NASPAN, ZOCOR, ASPIRIN. Patient recovered.
Rozerem Side Effects Report #5321633-4
Physician from UNITED STATES reported ROZEREM problem on Dec 21, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, feeling jittery, restless legs syndrome. ROZEREM dosage: 8 MG. Patient recovered.
Rozerem Side Effects Report #5321634-6
ROZEREM problem was reported by a Pharmacist from UNITED STATES on Dec 22, 2006. Male patient, 30 years of age, weighting 196.2 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: priapism. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321636-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Dec 27, 2006. Male patient, 48 years of age, weighting 215.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, dysgeusia, hallucination, visual, nervousness, pruritus. ROZEREM dosage: 8 MG, QHS AS REQUIRED, PER ORAL. During the same period patient was treated with LOPRESSOR, ASPIRIN. Patient recovered.
Rozerem Side Effects Report #5321637-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 27, 2006. Male patient, 81 years of age, weighting 200.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LIPITOR, TOPROL, ALTACE, NIACIN, SYNTHROID, COLCHICINE. Patient recovered.
Rozerem Side Effects Report #5321638-3
Physician from UNITED STATES reported ROZEREM problem on Nov 06, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling jittery. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321640-1
ROZEREM problem was reported by a Physician from UNITED STATES on Dec 28, 2006. Female patient, 42 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: sedation, somnolence. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321641-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 09, 2006. Female patient, 62 years of age, weighting 150.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: discomfort, dizziness, feeling abnormal, initial insomnia, nausea. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with AMBIEN, AMITRIPTYLINE, SYNTHROID, CRESTOR, TOPROL, FOSAMAX, VITAMIN. Patient recovered.
Rozerem Side Effects Report #5321642-5
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 31, 2006. Female patient, 67 years of age, weighting 190.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with AMBIEN, SYNTHROID, ZOLOFT, VITAMIN, LISINOPRIL. Patient recovered.
Rozerem Side Effects Report #5321643-7
Physician from UNITED STATES reported ROZEREM problem on Aug 21, 2006. Male patient, 76 years of age, weighting 230.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, dizziness, headache, initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LUNESTA, LORAZEPAM, ASPIRIN, FLOMAX, TRICOR, DETROL LA. Patient recovered.
Rozerem Side Effects Report #5321644-9
ROZEREM problem was reported by a Health Professional from UNITED STATES on Aug 29, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, middle insomnia. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321645-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 06, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dyspnoea, heart rate irregular, hypoaesthesia oral, nausea, pharyngeal hypoaesthesia. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321648-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 01, 2006. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, insomnia, middle insomnia. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321649-8
Physician from UNITED STATES reported ROZEREM problem on Oct 04, 2006. Female patient, 71 years of age, weighting 135.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue, insomnia, myalgia, palpitations, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with CRESTOR, SYNTHROID, FOSAMAX. Patient recovered.
Rozerem Side Effects Report #5321650-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 05, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia, nervousness, pruritus, tension. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5321651-6
Physician from UNITED STATES reported ROZEREM problem on Sept 06, 2006. Female patient, 18 years of age, weighting 135.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: gastrointestinal pain, sinusitis, somnolence, therapeutic response delayed. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LUNESTA, ETODOLAC, SINGULAIR, CYMBALTA, LEXAPRO, DARVOCET, ULTRAM, XANAX. Patient recovered.
Rozerem Side Effects Report #5321652-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 05, 2006. Female patient, 62 years of age, weighting 139.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, fall, initial insomnia, muscle injury. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LEXAPRO, THYROID, BIOIDENTICAL HORMONES. Patient recovered.
Rozerem Side Effects Report #5321653-X
Health Professional from UNITED STATES reported ROZEREM problem on Sept 08, 2006. Female patient, 38 years of age, weighting 164.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: lactation disorder. ROZEREM dosage: unknown. During the same period patient was treated with ZOLOFT, PRILOSEC. Patient recovered.
Rozerem Side Effects Report #5321655-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 02, 2007. Female patient, 45 years of age, weighting 170.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, delirium, initial insomnia, middle insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with HUMULIN R, SYNTHROID, COUMADIN, XANAX, METHADONE, CARBAMAZEPINE, FLEXERIL, ZOLOFT. Patient recovered.
Rozerem Side Effects Report #5321656-5
Physician from UNITED STATES reported ROZEREM problem on Dec 19, 2006. Female patient, 41 years of age, weighting 115.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with WELLBUTRIN, AMBIEN. Patient recovered.
Rozerem Side Effects Report #5321657-7
ROZEREM problem was reported by a Physician from UNITED STATES on Dec 07, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: migraine. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5321659-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Dec 11, 2006. Male patient, 32 years of age, weighting 135.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hiccups, initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with OXYCONTIN, LORTAB. Patient recovered.
Rozerem Side Effects Report #5321662-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 10, 2006. Female patient, 36 years of age, weighting 115.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, feeling abnormal, influenza like illness, muscle twitching. ROZEREM dosage: 8 MG, ONCE, PER ORAL. During the same period patient was treated with LUNESTA, AMITRIPTYLINE. Patient recovered.
Rozerem Side Effects Report #5322163-6
Physician from UNITED STATES reported ROZEREM problem on Dec 28, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nausea. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5322170-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 04, 2007. Female patient, 50 years of age, weighting 224.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia, somnolence. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with NAPROXEN, GYNDIOL. Patient recovered.
Rozerem Side Effects Report #5322171-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Jan 04, 2007. Male patient, 57 years of age, weighting 210.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, poor quality sleep. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with DOXEPIN, LOTENSIN HCT, NEXIUM. Patient recovered.
Rozerem Side Effects Report #5322383-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 23, 2006. Female patient, 67 years of age, weighting 145.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, dyspepsia, malaise, nausea, poor quality sleep. ROZEREM dosage: 8 MG, AS REQUIRED, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322384-2
Health Professional from UNITED STATES reported ROZEREM problem on Jan 09, 2007. Female patient, weighting 146.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal. ROZEREM dosage: unknown. During the same period patient was treated with EFFEXOR, ZOCOR, SYNTHROID, ALPRAZOLAM. Patient recovered.
Rozerem Side Effects Report #5322431-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 24, 2006. Male patient, 73 years of age, weighting 220.0 lb, was diagnosed with insomnia, sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: micturition disorder. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ALTACE, LIPITOR. Patient recovered.
Rozerem Side Effects Report #5322433-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 02, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322450-1
ROZEREM problem was reported by a Physician from UNITED STATES on Nov 02, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: no adverse effect, prescribed overdose. ROZEREM dosage: 16 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322452-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 31, 2006. Female patient, 70 years of age, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5322453-7
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 06, 2006. Female patient, 67 years of age, weighting 140.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, poor quality sleep. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with TOPROL, DIOVAN, ZETIA. Patient recovered.
Rozerem Side Effects Report #5322455-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 08, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, initial insomnia, nausea. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322483-5
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 05, 2007. Female patient, 57 years of age, weighting 155.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322502-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Jan 08, 2007. Female patient, 44 years of age, weighting 140.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue, nausea. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322504-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 08, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5322510-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Jan 12, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5322516-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 17, 2007. Female patient, 77 years of age, weighting 140.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LEXAPRO, COUMADIN, TRAMADOL, TYLENOL. Patient recovered.
Showing 1-50 of 1152 Next >
Drug Information: Ramelteon
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605038.html
ram el' tee onIMPORTANT WARNING:
| [Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html. |
Why is this medication prescribed?
See the MedWatch notification at the beginning of the monograph.
Ramelteon is used to help patients who have sleep-onset insomnia (difficulty falling asleep) fall asleep more quickly. Ramelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.
How should this medicine be used?
See the MedWatch notification at the beginning of the monograph.
Ramelteon comes as a tablet to take by mouth. It is usually taken once a day, no earlier than 30 minutes before bedtime. Do not take ramelteon with or shortly after a high fat meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ramelteon exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You may become sleepy soon after you take ramelteon. After you take ramelteon, you should complete any necessary bedtime preparations and go to bed. Do not plan any other activities for this time.
Your insomnia should improve after you begin treatment with ramelteon. Call your doctor if your insomnia does not improve at the beginning of your treatment. Also call your doctor if your insomnia gets worse or you notice unusual changes in your behavior at any time during your treatment.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
See the MedWatch notification at the beginning of the monograph.
Before taking ramelteon,
- tell your doctor and pharmacist if you are allergic to ramelteon or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone);certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aprepitant (Emend); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); clopidogrel (Plavix);efavirenz (Sustiva); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), others; fluvastatin (Lescol) fluvoxamine (Luvox); metronidazole (Flagyl);nefazodone; rifampin (Rifadin, Rimactane);sulfamethoxazole (Bactrim, Septra); sulfinpyrazone (Anturane); ticlopidine (Ticlid) ; and zarfirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD, damage to the lungs that makes breathing difficult), sleep apnea (breathing stops for a short time during sleep), depression, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ramelteon, call your doctor.
- you should know that ramelteon may make you drowsy during the daytime. Do not drive a car or operate machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcoholic beverages while you are taking ramelteon. Alcohol can add to the drowsiness caused by ramelteon.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
See the MedWatch notification at the beginning of the monograph.
Ramelteon may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness or tiredness
- dizziness
- upset stomach
- changes in the way food tastes
- muscle or joint pain
- stuffy or runny nose, cough, or other cold symptoms
- flu-like symptoms
Some side effects can be serious. If you experience any of these symptoms, call your doctor:
- stopping of menstrual periods
- milky discharge from the nipples
- decreased sexual desire
- fertility problems
- depression
Ramelteon may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
See the MedWatch notification at the beginning of the monograph.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand name(s):
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