Insomnia
Circadin® “not only improves the onset of sleep, but also improves the quality of sleep” says Nava Zisapel, company founder and Chief Scientific Officer of Neurim Pharmaceuticals. Dr. Zisapel, a Professor of Neurobiology at Tel Aviv University, reports that people who take the drug “have better daytime functioning and an improved quality of life.” The drug stimulates the body’s natural melatonin production. Her prolonged release formula of a mere 2mg dosage mimics the pineal gland’s production of the sleep inducing hormone. Melatonin production normally begins at dark, peaks at around 2am, and then gradually disappears at daylight. Dr. Zisapel began her work in 1992 and she received approval to market it in 2007. The European Medicines Agency (EMEA) at that time approved it for the short term (3 week) treatment of primary insomnia in patients over 55 years of age. The drug, unlike traditional sedatives, does not impair cognitive functions the following day, nor does it impair psychomotor skills. There are no abuse or dependency risks. Insomniacs, numbering nearly a third of the world’s population, will be cheered by the European Commission’s July, 2010 approval to expand the treatment duration from 3 weeks to 13 weeks. Circadin® is the first insomnia treatment approved for the extended length of time. It is currently marketed in Australia, Thailand, and Israel. US, Asian, and Latin American markets are in the registration process.
Insomnia, defined as the “difficulty to initiate or to maintain sleep,” affects almost all adults at one time or another. Transient (symptoms less than a week) insomnia and short term insomnia (one to three weeks) can occur as a result of jet lag, indigestion, shift work schedule changes, noisy sleep environments, stress, and recent medical situations. Long term (more than 3 weeks) or chronic insomnia is usually caused by psychological or medical conditions such as depression, pain, heart disease, acid reflux, asthma, sleep apnea, Parkinson’s disease, Alzheimer’s, brain tumors and strokes. Delayed or untreated insomnia costs America $42 billion dollars a year in healthcare costs. The seriously sleep deprived insomniacs have been limited to prescription sleep aids with their risks of dependency and abuse, or to over the counter antihistamines with their residual drowsiness hazards. The FDA has consistently discouraged natural supplements since they have no jurisdiction over them. They have issued warnings against the use of the natural alternatives of valerian, melatonin, and kava.
Circadin® is now in use in over 33 countries. It is naturally preferable to prescription sleep aids and their over the counter competitors. It’s time for the FDA to approve it for the sleepless and tired insomniacs of the USA. Everyone deserves a good night’s rest!
Copyright 2010. All rights reserved to Ronald Czarnecki.
