Newborn sleeping pills out of the

about 70 million Americans suffer from regular or accidental insomnia, but only 10 to 15 percent of patients seek treatment, some of them because of the side effects of sleeping pillsAs sleep deprivation causesdiseases, includingheartdiseases, the medical community is increasingly convinced that the treatment of insomnia is very importantAs a result, some pharmaceutical and biotech companies are targeting sleep disorders, and at least 12 sleeping pills are now in Phase II and III clinical trialsThe new generation of products is a welcomeaccording to the U.Ssleeping pill market statistics, in 2001, the sales of sleeping pills rose to about $4.6 billion in 2006, a compound annual growth rate of 29%;The core product of the current sleeping pill market is Zolpidem, Ambien, formerly sanofi-Avant's patented product, but its patent expired in April, and Sanofi-Avant has introduced a new generation of controlled release agents CR in response to the influx of generic drugsAlso on the market are Sepracor's Eszopiclone, Lunesta, Maciquina and fentanylGenerics account for two-thirds of the market" From a competitive point of view, Lunesta has an advantage over old sleeping pills and can therefore be used for a long timeOther drugs subject to safety restrictions can only be used for a short period of timeDespite its strength
s, Lunesta, like its competitors, remains under control because many sleeping pills are sold directly to consumers, so sales are affected by advertising, "just like antidepressants, sleeping pills are addictive and must be labeled as controlled drugs," according to analysts at theStandard s., the company's pharmaceutical industry analysts "
while generics have posed a threat to Ambien, analysts are confident that Ambien's replacement, AMBIEN CR, which went public in 2005, will recover lost ground through Ambien CR Sepracor, which is expanding Lunesta's overseas market, recently signed a cooperation agreement with Japan's Keoko and Axo Skour for the European market Previous sleeping pills have produced a lot of "junk", such as Goboxadol, developed in collaboration with Merck and small biotech companies The development of new sleeping pills aimed at reducing dependence on drugs, reducing hangovers and associated side effects is an encouraging improvement Leading drug research
currently making rapid progress in sleeping pills are Somaxon Pharmaceuticals and Neurocrine Biosciences, which are developing a new generation of safer sleeping pills Neurocrine's Indiplon and the quick-release agent Indiplon IR are not far from approval, but Indiplon MR, the Indiplon re-release agent, received a letter without permission So far, Neurocrine has not come up with a final plan Somaxon hopes to file an application for its drug Silenor with the FDA in early 2008 It is reported that the FDA to submit a new drug application, usually receive three responses: one is "approved", one is "approveable" and the other is "no approval." "Approveable" means that companies need to resubmit data or clinical trial results specifically requested by the FDA In the event of non-approval, the company may request a meeting with the FDA to understand why, so as to conduct further clinical studies and resubmit the application at a later date If Indiplon IR is approved, which means that further research by Neurocrine is required, and now Neurocrine has completed the re-application of Indiplon IR, which will be approved by the FDA as early as December At the same time, Somaxon is trying to file an application with the FDA, but the FDA needs further research data According to Somaxon, Silenor blocks histamine I receptors in the brain from releasing histamines, thus avoiding sleeping drug addiction Silenor's active ingredient is the anti-depressive neuropathic drug docepy Dossepine has been used to treat other indications for 30 years Silenor's Phase III clinical trialshowed statistically significant differences in both sleep and maintenance