Ramelteon: new drug. Insomnia: no role for risky placebos

(1) Patients complaining of insomnia should first be treated with non-drug measures (information, advice). Short-course benzodiazepine therapy can be tried if non-drug measures and established herbal remedies fail; (2) Ramelteon, a drug that antagonises receptors for melatonin, a hormone involved in circadian rhythms, is being considered for European marketing authorization in the treatment of insomnia; (3) Ramelteon has only been compared with placebo in clinical trials. Only one of three trials in which the patients were studied in their normal environment showed that ramelteon reduced the time to sleep onset, only by about 10 minutes. A similar reduction was observed in the artificial conditions of a sleep laboratory. There was no effect on sleep duration or on the number of night-time awakenings; (4) Ramelteon does not appear to have the disadvantages of benzodiazepines, such as residual daytime drowsiness, rebound insomnia on drug withdrawal, and dependence. But ramelteon provokes hyperprolactinaemia and was carcinogenic in experimental animals; (5) In practice, when a drug is needed for a patient complaining of insomnia, the best options are phytotherapy or short-course benzodiazepine treatment.