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Review Rozerem Safety Reports submitted to FDA

Total Rozerem reports: 1389.
Rozerem FDA safety alerts: 2007 .
Reported deaths: 14    Reported hospitalizations: 37.
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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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Rozerem Side Effects Report #5461049-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 25, 2007. Male patient, 72 years of age, weighting 180.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, feeling jittery. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5461051-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on June 12, 2007. Male patient, 44 years of age, weighting 195.0 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: abnormal dreams, poor quality sleep. ROZEREM dosage: 8 MG, PER ORAL. During the same period patient was treated with LUNESTA, NEXIUM, CRESTOR. Patient recovered.

Rozerem Side Effects Report #5461052-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 12, 2007. Female patient, 55 years of age, weighting 135.0 lb, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5461054-7
ROZEREM problem was reported by a Health Professional from UNITED STATES on June 25, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.


Rozerem Side Effects Report #5461056-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 27, 2007. Female patient, weighting 100.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, nightmare. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with XANAX, NEFAZODONE, LAMICTAL, HYDROCODONE. Patient recovered.

Rozerem Side Effects Report #5461060-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 06, 2007. Male patient, 81 years of age, weighting 130.0 lb, was diagnosed with initial 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, HS, PER ORAL PER ORAL. During the same period patient was treated with SYNTHROID. Patient recovered.

Rozerem Side Effects Report #5461062-6
Physician from UNITED STATES reported ROZEREM problem on June 27, 2007. Female patient, 50 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: mental impairment. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5461065-1
ROZEREM problem was reported by a Physician from UNITED STATES on June 28, 2007. Female patient, 15 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, rash. ROZEREM dosage: 8 MG, ONCE, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5461067-5
Health Professional from UNITED STATES reported ROZEREM problem on July 02, 2007. Male patient, 46 years of age, weighting 155.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hallucination, middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.


Rozerem Side Effects Report #5461070-5
ROZEREM problem was reported by a Physician from UNITED STATES on July 10, 2007. Male patient, 68 years of age, weighting 165.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, poor quality sleep, restless legs syndrome. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with MAXZIDE, CLARITIN. Patient recovered.

Rozerem Side Effects Report #5461071-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 12, 2007. Female patient, 25 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, pain, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5461072-9
ROZEREM problem was reported by a Physician from UNITED STATES on May 08, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: influenza like illness. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5461073-0
Physician from UNITED STATES reported ROZEREM problem on June 12, 2007. Male patient, weighting 290.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with NORVASC, ALTACE, VIAGRA, LIPITOR. Patient recovered.

Rozerem Side Effects Report #5461074-2
ROZEREM problem was reported by a Physician from UNITED STATES on Feb 28, 2007. Female patient, weighting 210.0 lb, was diagnosed with circadian rhythm sleep disorder, insomnia, major depression and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: galactorrhoea. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with EFFEXOR, RITALIN. Patient recovered.


Rozerem Side Effects Report #5461075-4
Physician from UNITED STATES reported ROZEREM problem on June 06, 2007. Male patient, 47 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: derealisation, heart rate increased, paraesthesia, sensation of blood flow, sensory disturbance, spontaneous penile erection. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with PROTONIX, ASPIRIN, EXTENDED RELEASE NIACIN. Patient recovered.

Rozerem Side Effects Report #5461076-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on June 11, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, dizziness, hallucination, hyperhidrosis, middle insomnia, nausea. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5461078-X
Physician from UNITED STATES reported ROZEREM problem on July 11, 2007. 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 #5461079-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on June 02, 2007. Female patient, 30 years of age, was diagnosed with sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, nightmare, somnolence. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464701-9
Physician from UNITED STATES reported ROZEREM problem on July 11, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, depersonalisation, overdose. ROZEREM dosage: 16 MG, HS, PER ORAL. During the same period patient was treated with LORAZEPAM, NEURONTIN. Patient recovered.


Rozerem Side Effects Report #5464702-0
ROZEREM problem was reported by a Health Professional from UNITED STATES on July 10, 2007. Female 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 #5464706-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 16, 2007. Female patient, 66 years of age, weighting 120.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, feeling abnormal, middle insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ZETIA, LIPITOR, LISINOPRIL, COREG, PLAVIX, PRILOSEC, NEXIUM. Patient recovered.

Rozerem Side Effects Report #5464711-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 17, 2007. Female patient, 75 years of age, weighting 155.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, feeling abnormal, formication, initial insomnia, nausea, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with DIOVAN, TOPROL. Patient recovered.

Rozerem Side Effects Report #5464712-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 18, 2007. 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, hangover, headache, initial insomnia, nausea, unevaluable event. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464713-5
ROZEREM problem was reported by a Physician from UNITED STATES on May 02, 2007. Female patient, 55 years of age, weighting 163.0 lb, was diagnosed with insomnia, asthma and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dyspnoea, wheezing. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with THEOPHYLLINE, TRAZODONE, CARBAMAZEPINE, PHENOBARBITAL, SYNTHROID, CYTOMEL, ALLEGRA D, DIAMOX. Patient recovered.

Rozerem Side Effects Report #5464714-7
Physician from UNITED STATES reported ROZEREM problem on July 10, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: galactorrhoea. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464720-2
ROZEREM problem was reported by a Physician from UNITED STATES on July 12, 2007. Female patient, 49 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: menorrhagia. ROZEREM dosage: 8 MG, HS, PER ORAL, 8 MG, HS, PER ORAL. During the same period patient was treated with LIPITOR. Patient recovered.

Rozerem Side Effects Report #5464721-4
Physician from UNITED STATES reported ROZEREM problem on Feb 06, 2007. Female patient, 72 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: feeling jittery, middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL, 8 MG, HS, PER ORAL. During the same period patient was treated with ZOCOR, HYZAAR, ATENOLOL, POTASSIUM CHLORIDE, PRILOSEC. Patient recovered.

Rozerem Side Effects Report #5464722-6
ROZEREM problem was reported by a Physician from UNITED STATES on July 16, 2007. Male patient, weighting 175.0 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, hangover, mental impairment. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with IBUPROFEN. Patient recovered.

Rozerem Side Effects Report #5464723-8
Physician from UNITED STATES reported ROZEREM problem on June 13, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: depression. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464735-4
ROZEREM problem was reported by a Physician from UNITED STATES on June 06, 2007. Female patient, 65 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: hangover, initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with NORVASC, ATACAND, FOSAMAX, SINGULAIR, VALTREX, EXTRA STRENGTH TYLENOL, MUCINEX, VITAMIN. Patient recovered.

Rozerem Side Effects Report #5464736-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 26, 2007. Male patient, 42 years of age, weighting 155.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: epistaxis, initial insomnia, sinus congestion. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464737-8
ROZEREM problem was reported by a Physician from UNITED STATES on May 31, 2007. Male patient, 45 years of age, weighting 245.0 lb, was diagnosed with poor quality sleep and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, spontaneous penile erection. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with VICODIN, XANAX, ADDERALL. Patient recovered.

Rozerem Side Effects Report #5464743-3
Physician from UNITED STATES reported ROZEREM problem on June 12, 2007. Female patient, 44 years of age, weighting 180.0 lb, was diagnosed with postoperative care and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, middle insomnia, pain in extremity. ROZEREM dosage: unknown. During the same period patient was treated with CELEBREX, EFFEXOR, ESTRACE, LORTAB ELIXIR. Patient recovered.

Rozerem Side Effects Report #5464745-7
ROZEREM problem was reported by a Physician from UNITED STATES on June 21, 2007. Female patient, 73 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: pain in extremity, stomach discomfort. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464746-9
Physician from UNITED STATES reported ROZEREM problem on July 16, 2007. Female patient, 57 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: dyssomnia, fatigue, initial insomnia, middle insomnia, poor quality sleep. ROZEREM dosage: 5 MG, QHS, PER ORAL. During the same period patient was treated with HYDROCHLOROTHIAZIDE, CYMBALTA, LISINOPRIL, ZOCOR, LORATADINE, TRAVATAN DROPS, ASPIRIN, VITAMIN. Patient recovered.

Rozerem Side Effects Report #5464747-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 05, 2007. Female patient, 25 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare, sleep disorder. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464760-3
Physician from UNITED STATES reported ROZEREM problem on July 05, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: overdose. ROZEREM dosage: 8 MG, PER ORAL; 16 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464768-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 02, 2007. Female patient, 46 years of age, weighting 150.0 lb, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness. ROZEREM dosage: unknown. During the same period patient was treated with VYTORIN, ALLEGRA, YASMIN. Patient recovered.

Rozerem Side Effects Report #5464769-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 10, 2007. Male 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 #5464771-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 10, 2007. Female patient, 72 years of age, weighting 175.0 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 AS REQUIRED, PER ORAL. During the same period patient was treated with VITAMIN, GLUCOSAMINE, ASPIRIN, PREVACID. Patient recovered.

Rozerem Side Effects Report #5464777-9
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 13, 2007. Female patient, 28 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, AS REQUIRED, PER ORAL. During the same period patient was treated with AMBIEN CR, LUNESTA. Patient recovered.

Rozerem Side Effects Report #5464778-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 17, 2007. Female patient, 66 years of age, weighting 147.0 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 EVISTA, MIACALCIN. Patient recovered.

Rozerem Side Effects Report #5464779-2
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 16, 2007. Female patient, 64 years of age, weighting 160.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, middle insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ETODOLAC, PREVACID, ASTELIN, BROMFENEX PD, ASPIRIN. Patient recovered.

Rozerem Side Effects Report #5464780-9
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 16, 2007. Male patient 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, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464786-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 18, 2007. Female patient, 18 years of age, weighting 110.0 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. Patient recovered.

Rozerem Side Effects Report #5464787-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Female patient, 75 years of age, weighting 169.0 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. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ZOLOFT, ATIVAN, LOPRESSOR, NORVASC, MAXZIDE, SYNTHROID, ASPIRIN, MOBIC. Patient recovered.

Rozerem Side Effects Report #5464788-3
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 20, 2007. Male patient, 68 years of age, weighting 175.0 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 OMEPRAZOLE. Patient recovered.

Rozerem Side Effects Report #5464789-5
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 20, 2007. Female patient, 76 years of age, weighting 126.0 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. Patient recovered.

Rozerem Side Effects Report #5464790-1
Health Professional from UNITED STATES reported ROZEREM problem on May 30, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464796-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on May 01, 2007. Male patient, 23 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: initial insomnia. ROZEREM dosage: 5 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464797-4
Physician from UNITED STATES reported ROZEREM problem on July 12, 2007. Male patient, 49 years of age, weighting 195.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hallucination, tactile, hallucination, visual. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with WELLBUTRIN, ALLEGRA, LIPITOR, METHIMAZOLE. Patient recovered.

Rozerem Side Effects Report #5464798-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Male patient, 59 years of age, weighting 212.0 lb, was diagnosed with insomnia, blood glucose increased and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, headache, stomach discomfort. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ACTOS, IBUPROFEN, ABILIFY, PROVIGIL, LIPITOR, CYMBALTA, CHANTIX, ENABLEX. Patient recovered.

Rozerem Side Effects Report #5464805-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 10, 2007. Male patient, 53 years of age, weighting 212.0 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 XANAX, SYNTHROID, BENICAR. Patient recovered.

Rozerem Side Effects Report #5464811-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 17, 2007. Male patient, 56 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: initial insomnia, middle insomnia, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with LIPITOR. Patient recovered.

Rozerem Side Effects Report #5464812-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 20, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, poor quality sleep. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464818-9
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 17, 2007. Female patient, 60 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: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with CALCIUM, VITAMIN E, ASCORBIC ACID, FISH OIL. Patient recovered.

Rozerem Side Effects Report #5464819-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 20, 2007. Male patient, 61 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: unknown. During the same period patient was treated with SINGULAIR. Patient recovered.

Rozerem Side Effects Report #5464820-7
ROZEREM problem was reported by a Physician from UNITED STATES on June 19, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: libido decreased. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464822-0
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on June 12, 2007. Female patient, 78 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: dizziness. ROZEREM dosage: unknown. During the same period patient was treated with LUNESTA, AVAPRO, TOPROL, FISH OIL, CALCIUM, GLUCOSAMINE. Patient recovered.

Rozerem Side Effects Report #5464830-X
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on June 27, 2007. Male patient was diagnosed with middle 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. Patient recovered.

Rozerem Side Effects Report #5464831-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Apr 23, 2007. Female patient, 47 years of age, weighting 105.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, somnolence, vision blurred. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with FROVA, EXCEDRIN TENSION, ASPIRIN, UNK VITAMIN. Patient recovered.

Rozerem Side Effects Report #5464832-3
ROZEREM problem was reported by a Physician from UNITED STATES on Apr 23, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: confusional state, disorientation, initial insomnia, movement disorder. ROZEREM dosage: 8 MG, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464837-2
Physician from UNITED STATES reported ROZEREM problem on Apr 23, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: agitation, irritability. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464838-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 24, 2007. Male patient, 38 years of age, weighting 286.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: urine cannabinoids increased. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with ABILIFY, WELLBUTRIN, PROZAC, LAMICTAL. Patient recovered.

Rozerem Side Effects Report #5464839-6
Health Professional from UNITED STATES reported ROZEREM problem on May 22, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464845-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 25, 2007. Female patient, 51 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: feeling jittery, poor quality sleep. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with ATIVAN. Patient recovered.

Rozerem Side Effects Report #5464846-3
Physician from UNITED STATES reported ROZEREM problem on June 27, 2007. Female patient, 20 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: diarrhoea, dizziness, vomiting. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464847-5
ROZEREM problem was reported by a Physician from UNITED STATES on May 31, 2007. Female patient, 29 years of age, weighting 186.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: confusional state, dizziness, nausea, palpitations, vomiting. ROZEREM dosage: 8 MG, ONCE, PER ORAL. During the same period patient was treated with ULTRAM. Patient recovered.

Rozerem Side Effects Report #5464854-2
Physician from UNITED STATES reported ROZEREM problem on Apr 27, 2007. Female 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: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464855-4
ROZEREM problem was reported by a Physician from UNITED STATES on June 18, 2007. Male patient, 46 years of age, weighting 195.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: agitation, initial insomnia, irritability, restlessness. ROZEREM dosage: unknown. During the same period patient was treated with PROZAC, ADDERALL. Patient recovered.

Rozerem Side Effects Report #5464861-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on May 02, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, agitation, irritability. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464862-1
ROZEREM problem was reported by a Health Professional from UNITED STATES on May 01, 2007. Female patient 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 LEXAPRO. Patient recovered.

Rozerem Side Effects Report #5464868-2
Health Professional from UNITED STATES reported ROZEREM problem on May 01, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464869-4
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on May 02, 2007. Male patient, 53 years of age, weighting 215.0 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, malaise, nausea. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464870-0
Physician from UNITED STATES reported ROZEREM problem on May 04, 2007. Male patient, 65 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal sleep-related event. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464871-2
ROZEREM problem was reported by a Health Professional from UNITED STATES on May 01, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464877-3
Physician from UNITED STATES reported ROZEREM problem on May 02, 2007. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464879-7
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on May 03, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: swelling face. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464880-3
Physician from UNITED STATES reported ROZEREM problem on May 03, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dysphoria, nightmare, psychotic disorder. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464881-5
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on May 03, 2007. Male patient, 56 years of age, weighting 175.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: tinnitus. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with DALMANE, PRILOSEC, NIASPAN. Patient recovered.

Rozerem Side Effects Report #5464887-6
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on May 03, 2007. Female patient, 42 years of age, weighting 187.0 lb, was diagnosed with narcolepsy and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: crying, mood altered, premenstrual syndrome. ROZEREM dosage: unknown. During the same period patient was treated with THYROID, PROVIGIL, INDERAL. Patient recovered.

Rozerem Side Effects Report #5464888-8
ROZEREM problem was reported by a Physician from UNITED STATES on May 03, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464889-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on May 04, 2007. Female patient, 51 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dry mouth, oral pain, stomatitis. ROZEREM dosage: unknown. During the same period patient was treated with SYNTHROID, HYDROCHLOROTHIAZIDE. Patient recovered.

Rozerem Side Effects Report #5464893-1
ROZEREM problem was reported by a Health Professional from UNITED STATES on May 08, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464894-3
Health Professional from UNITED STATES reported ROZEREM problem on May 08, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464895-5
ROZEREM problem was reported by a Physician from UNITED STATES on May 10, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: urinary tract infection. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464896-7
Physician from UNITED STATES reported ROZEREM problem on July 02, 2007. Female 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 #5464897-9
ROZEREM problem was reported by a Physician from UNITED STATES on May 11, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: muscle spasms. ROZEREM dosage: unknown. During the same period patient was treated with EFFEXOR. Patient recovered.

Rozerem Side Effects Report #5464898-0
Physician from UNITED STATES reported ROZEREM problem on May 14, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: rash. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464909-2
ROZEREM problem was reported by a Health Professional from UNITED STATES on May 14, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia. ROZEREM dosage: 8 MG, ONCE, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464910-9
Physician from UNITED STATES reported ROZEREM problem on May 14, 2007. Female patient, 28 years of age, was diagnosed with insomnia and 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 #5464911-0
ROZEREM problem was reported by a Physician from UNITED STATES on May 14, 2007. Female patient, 52 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, poor quality sleep, screaming. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464912-2
Physician from UNITED STATES reported ROZEREM problem on May 16, 2007. Female patient, 35 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety, delirium, insomnia, poor quality sleep. ROZEREM dosage: unknown. During the same period patient was treated with CLARINEX. Patient recovered.

Rozerem Side Effects Report #5464913-4
ROZEREM problem was reported by a Physician from UNITED STATES on May 17, 2007. Male patient, 69 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: irritability. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464920-1
Health Professional from UNITED STATES reported ROZEREM problem on May 18, 2007. Female patient, 87 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hallucination, photopsia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with ALPRAZOLAM. Patient recovered.

Rozerem Side Effects Report #5464921-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on July 12, 2007. Female patient, 39 years of age, weighting 119.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, initial insomnia, restlessness. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with SPIRONOLACTONE. Patient recovered.

Rozerem Side Effects Report #5464922-5
Physician from UNITED STATES reported ROZEREM problem on May 21, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5464923-7
ROZEREM problem was reported by a Health Professional from UNITED STATES on May 22, 2007. Female 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 #5464929-8
Physician from UNITED STATES reported ROZEREM problem on May 31, 2007. Male patient, 82 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5464930-4
ROZEREM problem was reported by a Physician from UNITED STATES on May 31, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.

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