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From simple mix-ups to fatal overdoses, medication mistakes happen, on average, once a day to every hospital patient, a new report says. Nationwide, at least 1.5 million people annually are harmed from drug errors, more than half of them in nursing homes, said the Institute of Medicine report, released yesterday.
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Only Drugs That are Safe Should be put on the Market. Drug developers are just beginning to come to grips with recent FDA oversight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals.

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Total Rozerem reports: 1152.
Rozerem FDA safety alerts: 2007 .
Reported deaths: 5    Reported hospitalizations: 33.
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FDA Reported Rozerem Side Effects: initial insomnia, middle insomnia, poor quality sleep, somnolence, insomnia, feeling abnormal, nightmare, fatigue, abnormal dreams, nausea, headache.
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Showing 1-100 of 1152 Next >

Rozerem Side Effects Report #5322532-4
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Jan 02, 2007. Male patient, 75 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: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with DIOVAN. Patient recovered.

Rozerem Side Effects Report #5322533-6
ROZEREM problem was reported by a Pharmacist from UNITED STATES on Dec 15, 2006. Male patient, 56 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: arthralgia, myalgia, sleep disorder. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322540-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Dec 27, 2006. Female patient, 64 years of age, weighting 128.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LIPITOR, CALCIUM, ASPIRIN. Patient recovered.

Rozerem Side Effects Report #5322542-7
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 27, 2006. Male patient, 56 years of age, weighting 175.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322548-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Dec 08, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322553-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 13, 2006. Female patient, 51 years of age, weighting 160.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: depression, middle insomnia. ROZEREM dosage: unknown. During the same period patient was treated with ZOLOFT. Patient recovered.

Rozerem Side Effects Report #5322566-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Dec 13, 2006. Female patient 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 #5322568-3
ROZEREM problem was reported by a Physician from UNITED STATES on Oct 23, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5322569-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 15, 2006. Male patient, 73 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: initial insomnia, therapeutic response delayed. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ZOCOR, FELODIPINE, PLAVIX, COZAAR. Patient recovered.

Rozerem Side Effects Report #5322575-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 26, 2006. Female patient, 55 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: flatulence, nausea. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with CYMBALTA, KLONOPIN, SEROQUEL. Patient recovered.

Rozerem Side Effects Report #5322576-2
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 25, 2006. Female patient, 21 years of age, weighting 130.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322578-6
ROZEREM problem was reported by a Health Professional from UNITED STATES on Oct 26, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: lip swelling. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5322579-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 15, 2006. Female patient, 54 years of age, weighting 130.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue, hangover, headache, initial insomnia, mental impairment, middle insomnia, poor quality sleep, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with PREDNISONE. Patient recovered.

Rozerem Side Effects Report #5322580-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 01, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling hot, hyperhidrosis, insomnia, nervousness, psychomotor hyperactivity. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5322581-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 31, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: menstruation irregular. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5322930-9
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 27, 2006. Female patient, 60 years of age, weighting 184.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nausea. ROZEREM dosage: unknown. During the same period patient was treated with LUNESTA, VALSARTAN, FOLIC ACID, OMEPRAZOLE, SIMVASTATIN, ASPIRIN, METFORMIN, NICOTINIC ACID. Patient recovered.

Rozerem Side Effects Report #5322931-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 27, 2006. Male patient, 82 years of age, weighting 178.0 lb, was diagnosed with rapid eye movements sleep abnormal 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 KLONOPIN. Patient recovered.

Rozerem Side Effects Report #5322938-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 29, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322960-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 13, 2006. Male patient, 74 years of age, weighting 200.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LIPITOR, AVANDIA. Patient recovered.

Rozerem Side Effects Report #5322962-0
ROZEREM problem was reported by a Physician from UNITED STATES on Nov 14, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dysgeusia. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322965-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 15, 2006. Female patient, 57 years of age, weighting 136.0 lb, was diagnosed with initial insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: 8 MG, ONCE, PER ORAL. During the same period patient was treated with PLAQUENIL, THYROID. Patient recovered.

Rozerem Side Effects Report #5322967-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 16, 2006. Male patient, 58 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: headache. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5322972-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Nov 21, 2006. Female patient, 76 years of age, weighting 125.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218484-8
ROZEREM problem was reported by a Physician from UNITED STATES on Sept 26, 2006. Male patient, 28 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: migraine with aura. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218493-9
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 02, 2006. Female patient, 32 years of age, weighting 193.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: flatulence, initial insomnia, muscle spasms, stomach discomfort. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with XANAX. Patient recovered.

Rozerem Side Effects Report #5218505-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 03, 2006. Female patient, 59 years of age, weighting 130.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: asthenopia, hangover, head discomfort, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with DILTIAZEM, LISINOPRIL, LIPITOR, TOPROL, ESTRATEST. Patient recovered.

Rozerem Side Effects Report #5218508-8
Health Professional from UNITED STATES reported ROZEREM problem on Oct 04, 2006. Female patient, 30 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling jittery, poor quality sleep. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5218510-6
ROZEREM problem was reported by a Health Professional from UNITED STATES on Oct 04, 2006. Male patient, 20 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling jittery, poor quality sleep. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5218515-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 04, 2006. Female patient, 75 years of age, weighting 140.0 lb, was diagnosed with circadian rhythm sleep disorder, prophylaxis and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: derealisation, hallucination. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with COZAAR, SEREVENT, NEXIUM, XALATAN, SPIRIVA, ALBUTEROL. Patient recovered.

Rozerem Side Effects Report #5218522-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 06, 2006. Female patient, 86 years of age, weighting 100.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: asthenia, dizziness, feeling abnormal, initial insomnia, somnolence. ROZEREM dosage: 8 MGS, QHS, PER ORAL. During the same period patient was treated with CENTRUM, CALCIUM PLUS D, GLUCOSAMINE. Patient recovered.

Rozerem Side Effects Report #5218524-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 06, 2006. Female patient, 32 years of age, weighting 160.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: pain, stomach discomfort. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218526-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 09, 2006. Female patient, 57 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: poor quality sleep, thinking abnormal. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with CITALOPRAM HYDROBROMIDE. Patient recovered.

Rozerem Side Effects Report #5218528-3
Physician from UNITED STATES reported ROZEREM problem on Oct 09, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, feeling jittery, nausea. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218529-5
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 09, 2006. Male patient, 64 years of age, weighting 160.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, pain, paraesthesia, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with NIASPAN, LOVASTATIN, AMBIEN. Patient recovered.

Rozerem Side Effects Report #5218530-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 09, 2006. Female patient, 66 years of age, weighting 138.0 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, sleep disorder. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with LEVOTHYROXINE, XANAX. Patient recovered.

Rozerem Side Effects Report #5218532-5
ROZEREM problem was reported by a Physician from UNITED STATES on Oct 06, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, poor quality sleep. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5218535-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 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. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218536-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2006. Female patient, 45 years of age, weighting 135.0 lb, was diagnosed with insomnia, myalgia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: alopecia, axillary mass, breast enlargement. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with CLONIDINE, REMERON, MILK OF MAGNESIA, OXYCONTIN, PHENOBARITAL, TOPAMAX, LIDODERM. Patient recovered.

Rozerem Side Effects Report #5218539-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 10, 2006. Female patient, weighting 120.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, feeling abnormal, middle insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with PRILOSEC, ESTRADIOL. Patient recovered.

Rozerem Side Effects Report #5218548-9
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 13, 2006. Female patient, 37 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: nervousness. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5218549-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Oct 17, 2006. Female patient, 77 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: increased appetite, weight increased. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with PREMARIN, ARICEPT, PLAVIX, SYNTHROID. Patient recovered.

Rozerem Side Effects Report #5218552-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 18, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: eye irritation, nasal discomfort. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219118-9
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 11, 2006. Male patient, 65 years of age, weighting 170.0 lb, was diagnosed with fear, insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, middle insomnia, sedation. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with ACCUPRIL, AMBIEN. Patient recovered.

Rozerem Side Effects Report #5219121-9
ROZEREM problem was reported by a Physician from UNITED STATES on Sept 11, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dry mouth, headache, insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219124-4
Physician from UNITED STATES reported ROZEREM problem on Sept 11, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, rash, urticaria. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219135-9
ROZEREM problem was reported by a Health Professional from UNITED STATES on Sept 15, 2006. Female patient, 60 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, restlessness. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219143-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 18, 2006. Female patient, 56 years of age, weighting 200.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, middle insomnia, myalgia, nausea. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LEXAPRO, NASONEX. Patient recovered.

Rozerem Side Effects Report #5219145-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 20, 2006. Female patient, 60 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: abdominal distension, breast enlargement, weight increased. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LIPITOR. Patient recovered.

Rozerem Side Effects Report #5219163-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 20, 2006. Male patient, 68 years of age, weighting 180.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: chills, dry mouth, initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with KLONOPIN, ATENOLOL, LIPITOR, ASPIRIN, GLUCOSAMINE. Patient recovered.

Rozerem Side Effects Report #5219179-7
ROZEREM problem was reported by a Physician from UNITED STATES on Sept 20, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, somnolence. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219301-2
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 13, 2006. Male patient, 76 years of age, weighting 178.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with EFFEXOR, MICARDIS, SINEMET, TOPROL, PROTONIX, PRAVACHOL. Patient recovered.

Rozerem Side Effects Report #5219302-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 14, 2006. Female patient, 52 years of age, weighting 160.0 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 TRAZODONE, ZESTRIL, NEXIUM. Patient recovered.

Rozerem Side Effects Report #5219303-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 06, 2006. Female patient, 68 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: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with VYTORIN. Patient recovered.

Rozerem Side Effects Report #5219305-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 08, 2006. Female patient, 58 years of age, weighting 142.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia, middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with ZELNORM, PREVACID, CALCIUM, VITAMIN, FLONASE. Patient recovered.

Rozerem Side Effects Report #5219308-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 11, 2006. Female patient, 82 years of age, weighting 151.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: unknown. During the same period patient was treated with AMBIEN, EVISTA, ESTROGENIC SUBSTANCE, GARLIC, VITAMIN, ASPIRIN, LYSINE. Patient recovered.

Rozerem Side Effects Report #5219312-7
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2006. Female patient, 52 years of age, weighting 180.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: unknown. During the same period patient was treated with ZOLOFT. Patient recovered.

Rozerem Side Effects Report #5219315-2
Physician from UNITED STATES reported ROZEREM problem on Aug 21, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219332-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES 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. Patient recovered.

Rozerem Side Effects Report #5219337-1
Physician from UNITED STATES reported ROZEREM problem on Aug 22, 2006. Male patient, 44 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: abnormal dreams, arrhythmia, fatigue, hypersomnia, pain, ventricular extrasystoles. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with AMIODARONE, PLAVIX, ASPIRIN, PEPCID, LIPITOR, BUSPAR, DOXYCYCLINE. Patient recovered.

Rozerem Side Effects Report #5219369-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2006. Male patient, 47 years of age, weighting 205.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: prescribed overdose, therapeutic response delayed. ROZEREM dosage: unknown. During the same period patient was treated with CYMBALTA, VALIUM, TYLENOL #. Patient recovered.

Rozerem Side Effects Report #5219378-4
Physician from UNITED STATES reported ROZEREM problem on Aug 29, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219382-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 05, 2006. Female patient, 85 years of age, weighting 160.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: back pain, initial insomnia, mobility decreased, muscular weakness, pain in extremity. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with TEMAZEPAM, WARFARIN, ATENOLOL, FLECAINIDE, NORVASC, PRILOSEC. Patient recovered.

Rozerem Side Effects Report #5219396-6
Physician from UNITED STATES reported ROZEREM problem on Sept 05, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: electroencephalogram abnormal. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219401-7
ROZEREM problem was reported by a Physician from UNITED STATES 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. Patient recovered.

Rozerem Side Effects Report #5219407-8
Consumer or non-health professional 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 #5219417-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 07, 2006. Female patient, 80 years of age, weighting 114.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anorexia, confusional state. ROZEREM dosage: unknown. During the same period patient was treated with SEROQUEL, CELEXA, NITROGLYCERIN, MORPHINE. Patient recovered.

Rozerem Side Effects Report #5219433-9
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 11, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, vision blurred. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with SEROQUEL, NEURONTIN, LIPITOR, POTASSIUM, ZOLOFT. Patient recovered.

Rozerem Side Effects Report #5219623-5
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES 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, hypoaesthesia oral, nausea. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219635-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 06, 2006. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5219640-5
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 22, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: contusion, sleep walking. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219645-4
Physician from UNITED STATES reported ROZEREM problem on Aug 24, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5219675-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 02, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, middle insomnia, neck pain, rash, stomach discomfort. ROZEREM dosage: 8 MG, ONCE, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220040-2
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 25, 2006. Female patient, 71 years of age, weighting 160.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, middle insomnia, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with CYMBALTA. Patient recovered.

Rozerem Side Effects Report #5220070-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 18, 2006. 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. During the same period patient was treated with AMBIEN. Patient recovered.

Rozerem Side Effects Report #5220076-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 19, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220087-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 25, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220096-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 31, 2006. Female patient, 80 years of age, weighting 102.0 lb, 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: 8 MG, QHS, PER ORAL. During the same period patient was treated with VITAMIN, ENALAPRIL MALEATE, TOPROL, CLONAZEPAM, AMBIEN. Patient recovered.

Rozerem Side Effects Report #5220100-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 01, 2006. Female patient, 46 years of age, weighting 120.0 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 LEVLITE. Patient recovered.

Rozerem Side Effects Report #5220101-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 02, 2006. Female patient, 53 years of age, weighting 110.0 lb, was diagnosed with initial insomnia, middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: diarrhoea, insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.

Rozerem Side Effects Report #5220102-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 02, 2006. Male 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: insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with TRAZODONE, PRILOSEC. Patient recovered.

Rozerem Side Effects Report #5220108-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 04, 2006. Female patient, 44 years of age, weighting 160.0 lb, was diagnosed with initial insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, initial insomnia, palpitations, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ACIPHEX. Patient recovered.

Rozerem Side Effects Report #5220132-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 15, 2006. Female patient, 54 years of age, weighting 154.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with PAXIL CR. Patient recovered.

Rozerem Side Effects Report #5220134-1
Physician from UNITED STATES reported ROZEREM problem on Aug 16, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220135-3
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 16, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: prescribed overdose. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220136-5
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 23, 2006. Female patient, 50 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: middle insomnia, poor quality sleep. ROZEREM dosage: 8 MG, HS PER ORAL. During the same period patient was treated with SEROQUEL, LEVOTHYROXINE, DIOVAN, LEXAPRO, VALTREX. Patient recovered.

Rozerem Side Effects Report #5220137-7
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 27, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: unknown. During the same period patient was treated with AMBIEN. Patient recovered.

Rozerem Side Effects Report #5220138-9
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 23, 2006. Male patient, 73 years of age, weighting 180.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with VERAPAMIL, ALTOPREV, HYDROCODONE, BUSPIRONE, REQUIP, FLOMAX. Patient recovered.

Rozerem Side Effects Report #5220139-0
ROZEREM problem was reported by a Health Professional from UNITED STATES on Aug 28, 2006. Female patient, 30 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with AMBIEN, REQUIP, ADVAIR, WELLBUTRIN, CLONAZEPAM, PROVIGIL, EFFEXOR, MIRAPEX. Patient recovered.

Rozerem Side Effects Report #5220140-7
Health Professional from UNITED STATES reported ROZEREM problem on Aug 28, 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 #5220143-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2006. Male patient, 52 years of age, weighting 160.0 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 ASPIRIN, AMBIEN. Patient recovered.

Rozerem Side Effects Report #5220162-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 06, 2006. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220239-5
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 14, 2006. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: pruritus. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5220241-3
Physician from UNITED STATES reported ROZEREM problem on Oct 17, 2006. Female patient was diagnosed with insomnia, hypothyroidism and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, chest pain, palpitations. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with SYNTHROID, HYZAAR. Patient recovered.

Rozerem Side Effects Report #5220244-9
ROZEREM problem was reported by a Physician from UNITED STATES on Oct 17, 2006. Female patient was diagnosed with insomnia, hypothyroidism and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, chest pain, palpitations. ROZEREM dosage: 8 MG, ONCE, PER ORAL. During the same period patient was treated with SYNTHROID. Patient recovered.

Rozerem Side Effects Report #5220247-4
Physician from UNITED STATES reported ROZEREM problem on Sept 27, 2006. Male patient, 55 years of age, weighting 170.0 lb, was diagnosed with poor quality sleep and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: breast mass, breast pain, gynaecomastia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with VALIUM, VICODIN. Patient recovered.

Rozerem Side Effects Report #5220249-8
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 04, 2006. Male patient, 44 years of age, was diagnosed with initial insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: paraesthesia. ROZEREM dosage: 8 MG, PER ORAL. During the same period patient was treated with ABILIFY, PROVIGIL, STRATTERA, WELLBUTRIN, KLONOPIN. Patient recovered.

Rozerem Side Effects Report #5220250-4
Physician from UNITED STATES reported ROZEREM problem on July 31, 2006. Female patient, 61 years of age, weighting 144.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: derealisation, dizziness, fear of falling, feeling abnormal, hallucination, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with WELCHOL, BONIVA, ASPIRIN. Patient recovered.

Rozerem Side Effects Report #5220251-6
ROZEREM problem was reported by a Physician from UNITED STATES on July 26, 2006. Male patient, 52 years of age, weighting 144.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dissociation, disturbance in attention, dysphoria, middle insomnia, sleep disorder, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5220252-8
Physician from UNITED STATES reported ROZEREM problem on Aug 28, 2006. Female patient, 63 years of age, weighting 160.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hypersomnia, memory impairment, sudden onset of sleep, therapeutic response delayed, therapeutic response prolonged. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with CYMBALTA, PREMARIN, LISINOPRIL, NORVASC, EXCEDRIN. Patient recovered.

Rozerem Side Effects Report #5220253-X
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 28, 2006. Male patient, 56 years of age, weighting 186.0 lb, was diagnosed with sleep disorder, disturbance in attention and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, chest discomfort, chest pain, initial insomnia, poor quality sleep, restlessness. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ALPRAZOLAM, METHYLPHENIDATE, FLOMAX. Patient recovered.

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Drug Information: Ramelteon

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605038.html

ram el' tee on

IMPORTANT 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):

  • Rozerem®

Ask Our Patient Community about Rozerem

PatientsVille.com does not provide medical advice, diagnosis or treatment. The information contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments.


Thank you for visiting Patientsville.com. We hope you found our information about prescription drug side effects helpful. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Thank you for visiting Patientsville.net. Hope you enjoyed finding Rozerem safety information and found answers to Your Questions about Rozerem side effects

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