BETWEEN commercials for Levitra, Cialis, Zoloft and several other heavily advertised drugs, CNN announced that the FDA approved on Dec. 18, 2004 yet another drug, Lunesta. While the drug showed statistically significant improvements in clinical studies, the drug, as it is being marketed to doctors and patients, is being prematurely distributed with too few warnings.
Lunesta, a drug designed specifically for providing relief to insomnia patients, is unique in two very important ways. First of all, the FDA has put no formal time limit or even recommended one on Lunesta prescriptions, meaning patients can take Lunesta for as long as doctors are willing to order. This stands in stark contrast to Ambien, the current market leader in treating insomnia, which is habit-forming and rarely used for longer than 10 days at a time. Second, Lunesta, unlike Xanax, Valium, Serepax and several other well-known drugs, is neither a benzodiazepine (tranquilizer) nor a narcotic. Because most drugs for insomnia and other related disorders are benzodiazepines and narcotics, most of the available research has been directed towards those substances. Lunesta, by contrast, is a new drug to American society and therefore is less understood than the more conventional "sleeping pills," which come in the form of benzodiazepines and narcotics.
Simply the fact that this new drug is less understood than its market competitors implies that stricter scrutiny should be placed on long-term testing for Lunesta. However, testing on the drug lasted six months on 2,700 patients, which is acceptable by today's FDA standards. Yet this short-term testing is of questionable adequacy given that there is not a recommended time limit on the drug