Sepracor : LUNESTA Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry

May 12, 2008--Sepracor Inc. (Nasdaq: SEPR) announced the publication of a study of LUNESTA tablets in patients with insomnia and co-morbid generalized anxiety disorder (GAD) in the May issue of the Archives of General Psychiatry. This 595-patient study examined the safety and efficacy of LUNESTA co-administered with escitalopram oxalate, which is commonly used in the treatment of anxiety, versus co-administration of escitalopram and placebo in patients with insomnia and co-existing GAD. The study also evaluated the potential for co-administration of LUNESTA to increase the magnitude and/or accelerate the anxiolytic response versus escitalopram alone... Sepracor's Press Release -

Lundbeck : Circadin launch rollout starts with the launch of the product in the important German market

13-05-2008 - Lundbeck announced the launch of Circadin® for insomnia in Germany. Circadin® was approved by the European Commission on 29 June 2007, and Lundbeck expects to launch the product in another 14 markets during 2008.

"We are very happy to have launched Circadin® in Germany, which is the first of the 15 markets in Europe where Lundbeck expects to roll out Circadin® during 2008...

...Circadin® is the first and only IP-protected, prolonged-release, melatonin-containing prescription drug approved in the EU. Melatonin is a naturally occurring hormone produced by the pineal gland; and it has a pivotal role in the regulation of circadian rhythms and sleep... Lundbeck's Press Release -

SOMAXON PHARMACEUTICALS : CLINICAL DATA ON PRODUCT CANDIDATE FOR THE TREATMENT OF INSOMNIA PRESENTED

May 7, 2008 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that data from three Phase 3 clinical trials of the company’s product candidate SILENOR™ (doxepin HCl) for the treatment of insomnia were presented at the American Psychiatric Association (APA) 161st annual meeting in Washington, D.C..
The data presented at the APA meeting are a subset of the data from Somaxon’s completed Phase 3 development program, which comprised four Phase 3 clinical trials evaluating SILENOR™, a low-dose (1-6 mg) formulation of doxepin for the treatment of insomnia. As the company has previously reported, all of these clinical trials demonstrated statistically significant differences relative to placebo for their primary endpoints and multiple secondary endpoints. The clinical trials demonstrated significant and clinically meaningful improvements in sleep onset, sleep maintenance and the prevention of early morning awakenings... [PDF] Somaxon's Press Release -

Medison Pharma : Provigil is approved for Idiopathic Hypersomnia, Sleep Apnea and Shift Work Disorder treatment

May 14, 2008 Medication for Idiopathic Hypersomnia is approved in Israel

The Pharmaceutical Administration has approved Provigil for the treatment of Idiopathic Hypersomnia, Sleep Apnea and Shift Work Disorder

Dr. Itay Gal

Hundreds of Israelis suffer from Idiopathic Hypersomnia manifested by fatigue throughout the day, difficulty in maintaining wakefulness even after a long night sleep or after daytime naps.
Lately, the Israeli Ministry of Health has approved the marketing of Provigil for the purpose of providing solution for Idiopathic Insomnia as well.

This problem usually starts at adolescence. People suffering from Idiopathic Hypersomnia experience significant impairment in their quality of life, as well as difficulty in concentrating in all of their activities due to sleepiness, which is probably the result of dysfunction in their "biological clock"...

...Additional indication for the medication includes treating people suffering from Sleep Apnea Syndrome. The signs of this common syndrome are overweight, snoring, fatigue and sleepiness throughout the day. People suffering from this disorder experience cyclical interruptions during sleep causing short intervals of awakening from sleep without being aware of it. The number of awakenings from sleep can be dozens or even hundreds of times throughout the night...

...People suffering from Sleep Apnea are at increased risk for developing cardiovascular illness as well as being involved in road accidents and work-related accidents due to inadequate alertness. It is estimated that thousands of Israelis suffer from this problem and only few are diagnosed and treated. Treatment involves a multidisciplinary approach including weight loss, CPAP (Continuous Positive Airway Pressure) machines, surgery and dental devices. Despite optimal treatment, some patients still suffer from excessive sleepiness throughout the day requiring medicinal treatment.... Medison Pharma's Press Release -

Eurand : Launch of OTC Unisom SleepMelts by Chattem

April 29, 2008 – Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that Chattem, Inc. (“Chattem”) has launched a new orally disintegrating tablet (“ODT”) formulation of its popular over-the-counter (OTC) sleep-aid brand, Unisom^®.

Unisom^® SleepMelts^TM, which contains 25mg of diphenhydramine hydrochloride, was developed by Eurand using its AdvaTab^® and Microcaps^® taste-masking technologies. The product was developed as part of the EUR-1047 program. Unisom^® SleepMelts^TM, an OTC sleep-aid, is now available in leading U.S. mass merchandiser, drug and food retailers. Eurand will exclusively supply the product for Chattem, which will be manufactured at Eurand’s U.S. facility in Vandalia, OH... – Eurand's Press Release -

Pfizer : Lyrica Reduced Pain of Fibromyalgia in Patients Regardless of Symptoms of Anxiety or Depression

April 16, 2008 - -Pfizer’s Lyrica reduced pain of fibromyalgia in patients regardless of whether they experienced symptoms of anxiety or depression at the beginning of the study, according to a pooled analysis presented today at the American Academy of Neurology annual meeting. The analysis, which looked at data pooled from previous clinical trials, also showed that patients’ self-reported improvements were more closely associated with improvements in pain and sleep than with improvements in fatigue or symptoms of anxiety or depression.

Fibromyalgia is the most common, chronic widespread pain condition in the United States and is thought to result from neurological changes in how patients perceive pain. Fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue... Pfizer's Press Release -

Sanofi-aventis : Positive results from GEMS, the third Phase III trial evaluating eplivanserin in sleep quality

April 30, 20008 - ... Eplivanserin : Sanofi-aventis announced today that the GEMS Phase III study shows that the 5-HT2A antagonist eplivanserin in development for the treatment of insomnia characterized by sleep maintenance difficulties/night- time awakenings significantly reduces WASO (Wake time After Sleep Onset) and the number of night-time awakenings reported by the patient at 6 and 12 weeks of treatment, versus placebo. An improvement of the quality of sleep was also observed in the study.

These results confirm those of the EPLILONG study (phase III study conducted in similar conditions), which also showed that eplivanserin significantly reduces WASO and the number of night-time awakenings reported by the patient at 6 and 12 weeks, versus placebo and improves the quality of sleep... [PDF] Sanofi-aventis' Press Release -

XenoPort and GlaxoSmithKline : XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome

April 17, 2008 - Data from the first pivotal study of XP13512/GSK1838262, a sustained-release investigational compound to treat Restless Legs Syndrome (RLS), showed that it significantly improved the symptoms of moderate-to-severe primary RLS compared to placebo, and was generally well-tolerated when administered once-daily for 12 weeks Data from the PIVOT RLS I (Patient Improvement in Vital Outcomes following Treatment for RLS) clinical trial, formerly designated as study XP052, were presented today at the 60th annual meeting of the American Academy of Neurology (AAN). The investigational compound is being developed by XenoPort (Nasdaq: XNPT) - GSK.

"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in treating the symptoms of RLS in large controlled clinical trials... XenoPort's Press Release -

Transcept Pharmaceuticals : Study of Intermezzo by Leading Sleep Expert Published in "Human Psychopharmacology"

April 15, 2008: Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that a study evaluating the pharmacodynamics, pharmacokinetics, and tolerability profile of its lead product candidate,Intermezzo^®, has been published in Human Psychopharmacology. Intermezzo^® (zolpidem tartrate sublingual lozenge) is a low dose formulation of zolpidem designed to treat insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep... Transcept Pharmaceuticals' press Release -

SleepQuest : Medicare Approves In Home Sleep Apnea Testing

April 8, 2008 - The Centers for Medicare and Medicaid Services (CMS) have approved at-home sleep testing for obstructive sleep apnea (OSA). Previous policy had mandated that suspected sleep apnea sufferers undergo facility-based polysomnography. The new policy allows continuous positive airway pressure (CPAP) treatment for Medicare patients who are diagnosed via unattended home monitoring devices. This decision will likely prompt increased coverage from insurance companies around the country.“SleepQuest is very excited about the change in coverage as it demonstrates that our portable sleep testing program, which we have successfully offered for the past 14 years, is a viable and effective alternative to sleep lab testing... SleepQuest's Press Release -