Ramelteon: Insomnia: No role for risky placebos

Prescrire International

Volumn 17, Issue 97, 2008, Pages 183-186

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

BENZODIAZEPINE DERIVATIVE; CYTOCHROME P450 1A2; CYTOCHROME P450 2C; CYTOCHROME P450 3A4; FLUVOXAMINE; MELATONIN RECEPTOR; PLACEBO; RAMELTEON; RIFAMPICIN; TRIAZOLAM; INDENE DERIVATIVE; MELATONIN; NEW DRUG;

AROUSAL; ARTICLE; BEHAVIOR DISORDER; CARCINOGENICITY; CIRCADIAN RHYTHM; CLINICAL PRACTICE; CLINICAL TRIAL; DAYTIME SOMNOLENCE; DIZZINESS; DRUG ABUSE; DRUG BIOAVAILABILITY; DRUG DEPENDENCE; DRUG DOSE COMPARISON; DRUG MARKETING; DRUG METABOLISM; DRUG WITHDRAWAL; EUROPE; FALLING; FATIGUE; HUMAN; HYPERPROLACTINEMIA; INSOMNIA; MEDICAL DECISION MAKING; MEMORY DISORDER; NONHUMAN; PATIENT COUNSELING; PHYTOTHERAPY; PROLACTINOMA; RECEPTOR BLOCKING; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP TIME; TERATOGENICITY; DRUG APPROVAL; DRUG EFFECT; DRUG POTENTIATION; RANDOMIZED CONTROLLED TRIAL;

DRUG APPROVAL; DRUGS, INVESTIGATIONAL; EUROPE; HUMANS; INDENES; MELATONIN; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, MELATONIN; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 53849109629     PISSN: 11677422     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Prescrire Editorial Staff "Sleep complaints - If possible, avoid sleeping pills" this issue page 206.
2. Prescrire Editorial Staff "Melatonin and sleep disorders: no better than placebo" Prescrire Int 2006; 15 (86): 233.
3. U.S. Food and Drug Administration - Center for Drug Evaluation and Research "Application number 21-782. Medical review" 29 June 2005: 266 pages.
4. U.S. Food and Drug Administration - Center for Drug Evaluation and Research "Application number 21-782. Statistical review" 22 June 2005:47 pages.
5. Roth T et al. "Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia" Sleep Med 2006; 7: 312-318.
6. Roth T et al. "Ramelteon (TAK-375), a selective MTI/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment" Sleep 2005; 28 (3): 303-307 + (4): 417.
7. Johnson MW et al. "A novel hypnotic lacking abuse liability and sedative adverse effects" Arch Gen Psychiatry 2006; 63 (10): 1149-1157.
8. France CP et al. "Acute and chronic effects of ramelteon in Rhesus monkeys (Macaca mulatta): dependence liability studies" Behav Neurosci 2006; 120 (3): 535-541.
9. U.S. Food and Drug Administration - Center for Drug Evaluation and Research Application number 21-782. Statistical review and evaluation. Carcinogenicity study" 1 March 2005: 46 pages.
10. U.S. Food and Drug Administration - Center for Drug Evaluation and Research "Application number 21-782. Approved labeling" 22 July 2005: 22 pages.