Ramelteon: application withdrawn. Ramelteon in insomnia: withdrawal of marketing application in patients' best interests.
The European Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the use of the melatonin receptor agonist ramelteon in insomnia, due to its unfavourable risk-benefit balance. In France, melatonin itself is licensed for use in this indication.
D017277:Drug Approval; D005602:France; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007192:Indenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008389:Marketing of Health Services; D044094:Receptors, Melatonin / Q000819:agonists*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D006993:Hypnotics and Sedatives; D007192:Indenes; D044094:Receptors, Melatonin; C495910:ramelteon