Archive for May, 2007

Consumers who may still have this product in their homes are advised to consult with a health care professional before they stop taking the pills, because of the risk of withdrawal symptoms.

Eden Herbal Formulations Serenity Pills II is promoted as a herbal product to relieve sleeping difficulty. The product is not authorized for sale in Canada.

Estazolam belongs in the class of drugs known as benzodiazepines, which should only be prescribed by a health care professional.

Estazolam should not be used by people with an allergy to any benzodiazepines, such as Valium (diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals affected by the neuromuscular disorder myasthenia gravis or by sleep apnea.

Benzodiazepines, including estazolam, should only be used by pregnant women if absolutely necessary and with caution by the elderly and those with a history of substance abuse.

The side-effects associated with the use of products containing estazolam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.

These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research.

“However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.

Sleep remains one of the big mysteries in biology. All animals sleep, and people who are deprived of sleep suffer physically, emotionally and intellectually. But nobody knows how sleep restores the brain.

Now, Giulio Tononi, a professor of psychiatry at the University of Wisconsin-Madison School of Medicine and Public Health, has discovered how to stimulate brain waves that characterize the deepest stage of sleep.

The discovery could open a new window into the role of sleep in keeping humans healthy, happy and able to learn. The brain function in question, called slow wave activity, is critical to the restoration of mood and the ability to learn, think and remember, Tononi says.

During slow wave activity, which occupies about 80 percent of sleeping hours, waves of electrical activity wash across the brain, roughly once a second, 1,000 times a night.

In a new paper being published in the scientific journal PNAS, Tononi and colleagues, including Marcello Massimini, also of the UW-Madison School of Medicine and Public Health, described the use of transcranial magnetic stimulation (TMS) to initiate slow waves in sleeping volunteers. The researchers recorded brain electrical activity with an electroencephalograph (EEG).

Neurim Pharmaceuticals Ltd today announced that the Committee for Medicinal Products in Human use (CHMP) of the European Medicines Agency (EMEA) has issued an approval recommendation for Circadin 2 mg (prolonged-release melatonin) as monotherapy for the short-term treatment of Primary Insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

The marketing authorisation application for Circadin was submitted by Neurim Pharmaceuticals to EMEA on October 2005. The adoption of a positive recommendation is the last step in the European regulatory approval process prior to the granting of marketing authorisation by the European Commission.

Neurim anticipates that the Commission will ratify the CHMP opinion and issue marketing authorisation in the third quarter of 2007. If granted, the EU marketing authorisation will be valid in all 27-member states of the European Union.

“We are extremely pleased to have received the Committee’s positive recommendation, which is a significant step towards Circadin becoming an important new treatment option in the EU for patients aged 55 or over suffering from Primary Insomnia,” said Prof. Nava Zisapel, CSO of Neurim “Circadin was found effective in improving quality of sleep and sleep latency while also improving morning alertness and quality of life.

Chronic fatigue syndrome (CFS) has been associated with altered amounts of slow wave sleep, which could reflect reduced electroencephalograph (EEG) activity and impaired sleep regulation.

A study published in the journal SLEEP finds that CFS is also associated with a blunted slow wave activity (SWA) response to sleep challenge, suggesting an impairment of the basic sleep drive and homeostatic response.

The study, authored by Roseanna Armitage, PhD, and colleagues at the University of Michigan, focused on 13 pairs of identical twins discordant for CFS.

Analyses, which were restricted to the first four non-REM periods each night in order to show comparability, revealed that SWA, or other sleep EEG measures, did not differ between the CFS and healthy twins during a regular night’s sleep.

According to Armitage, it was only after a “challenge” to sleep regulation was introduced (keeping them awake an extra four hours) that the CFS twins exhibited significantly less SWA power in the first non-REM period of recovery sleep and accumulated a smaller percentage of SWA in the first non-REM period than their twin counterparts.

It is not surprising to realize that women tend to cut their sleep needs short. Today’s moms are busier than ever before with demands from all angles: from work, from their child’s school and from home.

Many times the only quiet, reflective part of the day is when an exhausted mom is climbing into bed.

And even then, many lie awake at night thinking about the next day’s tasks, stressing about household finances and worrying about family issues.

Further, when the kids are sleeping, moms can be tempted to begin projects that are impossible to complete when they are awake, which may lead to a delay in time-to-bed.

As Mother’s Day approaches, the American Academy of Sleep Medicine (AASM) reminds all mothers and all moms-to-be of the importance of a good night’s sleep to maintaining good health and optimum performance.

Susie Esther, MD, medical director of The Sleep Center at SouthPark, a part of Charlotte Eye, Ear, Nose and Throat Associates, P.A., and a member of the AASM board of directors, says that one of the other challenges for today’s mothers comes from shift work schedules.

May 1st kicks off Older Americans Month. This year’s theme is, "Older Americans: Making Choices for a Healthier Future." As people get older, several aspects of their lives change, including their sleep patterns.

While older adults need about seven to eight hours of sleep each night to maintain good health and optimum performance, many elders often get less sleep, mainly because they experience problems sleeping.

While sleep patterns change as people age, disturbed sleep and waking up tired every day are not part of normal aging.

The American Academy of Sleep Medicine (AASM) advises those who struggle with getting the sleep they need each night to see a sleep specialist.

Many adults often have more trouble falling asleep than persons in other age groups. A study of adults over the age of 65 found that 13 percent of men and 36 percent of women take more than 30 minutes to fall asleep.

Ralph Downey III, PhD, of the Sleep Disorders Center at Loma Linda University Medical Center in Loma Linda, Calif., says it is normal for our body clocks to change as we get older.

A generic drug already used by millions of Americans for high blood pressure and prostate problems has been found to improve sleep and lessen trauma nightmares in veterans with post traumatic stress disorder (PTSD).

“This is the first drug that has been demonstrated effective for PTSD nightmares and sleep disruption,” said Murray A. Raskind, MD, executive director of the mental health service at the Veterans Affairs Puget Sound Health Care System and lead author of a study appearing April 15 in Biological Psychiatry.

The randomized trial of 40 veterans compared a nightly dose of prazosin (PRAISE-oh-sin) with placebo over eight weeks. Participants continued to take other prescribed medications over the course of the trial.

At the end of the study, veterans randomized to prazosin reported significantly improved sleep quality, reduced trauma nightmares, a better overall sense of well being, and an improved ability to function.

“These nighttime symptoms are heavily troublesome to veterans,” said Raskind, who also is director of VA’s VISN 20 (Veterans Integrated Service Network #20) Mental Illness Research, Education and Clinical Centers program (MIRECC). “If you get the nighttime symptoms under control, veterans feel better all around.”