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Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today that Glenn A. Oclassen, President & Chief Executive Officer, is scheduled to present at the BMO Capital Markets Healthcare Conference in New York City on Wednesday, August 5, 2009 at 4:00 p.m., Eastern Time.

An audio webcast of the presentation will be available at www.transcept.com. The audio replay of the presentation will be available at the same location through September 4, 2009.

About Transcept Pharmaceuticals (TSPT)

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. Its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual tablet), has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. For further information, please visit the company's website at www.transcept.com.

About Intermezzo(R)

Intermezzo(R) (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo(R) is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo(R) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. As compared to placebo, two Phase 3 clinical studies of Intermezzo(R) showed a statistically significant reduction in the time it took patients to return to sleep after a middle of the night awakening, and there were no significant residual effects upon awakening four hours after dosing. Transcept believes that Intermezzo(R), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.

The U.S. Food and Drug Administration (FDA) has established October 30, 2009 as its target date under PDUFA (the Prescription Drug User Fee Act) to take action on its review of the New Drug Application (NDA) for Intermezzo(R). Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).

About Middle of the Night Awakenings

Waking up during the night is the most frequent insomnia symptom reported in the general population. Based on a recently published epidemiological study of nearly 9,000 individuals, the Stanford Sleep Epidemiology Research Center has estimated that about one-third of adults in the United States experience middle of the night awakenings at least three times each week. The study concluded that more than 90 percent of those subjects who experienced middle of the night awakenings reported that this insomnia symptom persisted for at least six months, and approximately 11 percent had consulted a physician in regard to this sleep condition. In the Stanford study, fewer than 25 percent of those experiencing middle of the night awakenings reported difficulty going to sleep at bedtime. According to IMS Health, the overall U.S. market for prescription sleep aids was approximately $4.0 billion in 2008.

SOURCE Transcept Pharmaceuticals, Inc.

Cephalon, Inc. (Nasdaq: CEPH) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.

"This supplemental New Drug Application for a new use of NUVIGIL is another important milestone for Cephalon. We hope that this will be the first of many new indications for NUVIGIL over the next five years," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon.

The NUVIGIL sNDA for the treatment of excessive sleepiness associated with jet lag disorder is based on data from a Phase 3 study, recently presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Washington. The data from this novel placebo-controlled pivotal study, which involved overseas air travel, included an evaluation of the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women who all had experienced jet lag symptoms at least once during the previous five years. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, diarrhea, and palpitations.

About NUVIGIL

NUVIGIL, the longer-lasting form of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not currently indicated for the treatment of jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

SOURCE Cephalon, Inc.

 

Sleep problem sometimes erupts out of nowhere with no traceable cause, at such times the culprit might be the medication. If a change in the sleeping pattern is noticed shortly after any medication or treatment is started it must be communicated with your doctor.
It is mandatory to mention the medicines taken, change in any dosage and thereof changes in sleep. Many prescription and non- prescription medication causes sleep problems.

To mention some of them, diet pills, hormonal pills, blood pressure pills, any long term sedatives used, medicines taken for asthma, seizure disorder, and medication for Parkinson's.
The after effects may differ from person to person, so remember to consult your family doctor for any changes.

Pic courtesy deletem3 on www.flickr.com

A natural hormone released by the pineal gland, that regulates the circadian rhythm of the body is known as melatonin. This hormone is available in a synthetic form in the form of a food supplement, which has a rapid and mild sleep inducing effect on the body, especially to shift workers and those with a jet lag.
Only those adults who are physically healthy and who do not have any other problem should take this supplement.

A new study shows that the erectile dysfunction drug Viagra may worsen sleep apnea, making it more difficult for men to get the oxygen their bodies need during sleep and increasing the risk of complications.

Sleep apnea is more common in men than in women and occurs when breathing regularly stops during sleep for 10 seconds or more due to an obstruction or narrowing of the airway in the nose, mouth, or throat causing symptoms that include snoring and loss of sleep.

In the study, published in the Archives of Internal Medicine, researchers examined the effects of a single 50-milligram dose of Viagra vs. placebo on 14 middle-aged men with severe obstructive sleep apnea. After taking Viagra or the placebo, the men were monitored all night with sleep tests that measured blood oxygen levels among other things.

The results showed that a single dose of Viagra significantly increased the amount of sleep time with a lower blood oxygen saturation level. The average blood oxygen saturation level was also lower after taking Viagra vs. placebo.

Researchers also found that breathing was more disordered — with more stops per hour among the men who took Viagra before sleeping.

Researcher Suely Roizenblatt, M.D., Ph.D., of the Federal University of Sao Paulo, Brazil, and colleagues say these results are only preliminary and based on a small number of men. Further studies will be necessary to determine if Viagra use is risky for men with severe sleep apnea.

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Two new studies by University of Michigan Health System researchers have found that  chemical imbalances in the brain may be partly to blame for certain life-disrupting sleep disorders. In a report published in the journal Neurology, the team reported apparent links between deficits in brain chemistry and obstructive sleep apnea (OSA) and REM sleep behavior disorder (RBD).

It seems logical then, that Selmedica Healthcare, a Memphis based company, has launched a new pill called 'Diavad' that helps you to sleep by restoring your body's  chemical and hormonal balance.

Diavad allows your body to achieve balance and permits you to maintain a normal, healthy sleep pattern, a company spokesman said.

“Diavad does not cause you to fall asleep, instead it restores your body’s own crucial chemical and hormonal balance which re-establishes a more natural and healthier sleep pattern,” the spokesman said. “We call it revolutionary because Diavad fights your sleeplessness symptoms from the inside - from every angle. It attacks the emotional, physical, and the psychological causes of sleep deprivation. You are actually receiving a system that is attacking your inability to sleep, overactive mind, and restlessness from every aspect.”

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Yaron Dagan, M.D., Ph.D., is the director of the Institute for Fatigue and Sleep Medicine at Chaim Sheba Medical Center in Israel, and has worked with over 600 patients who have sleep/ wake schedule disorders.

Dr Dagan reports that most of these patients have been treated successfully with melatonin.

"We found melatonin to be a very good treatment for these patients. In Israel, [melatonin] is a pharmaceutical substance that needs a physician's prescription and is prepared in pharmacies. The usual dosage...is 5 mg taken daily at a fixed time [usually 10 p.m. to 11 p.m.]. Melatonin treatment is well established in our treatment protocol," he said. "It has to be emphasized, however, that this treatment is only effective for biological rhythm disorders [sleep/wake schedule disturbances and jet lag], but it is not a miracle sleeping pill for psychophysiological insomnia."

Dagan added that he has not confronted any major side effect.

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Takeda Pharmaceuticals North America Inc. has launched an ad campaign for its new sleeping pill, Rozerem. Rozerem was approved by the Food and Drug Administration last year as the first sleeping medication not designated as a controlled substance, therefore lacking potential for abuse.

The company and studies indicate the drug lacks the risk of chemical abuse or dependency that other prescription sleeping aids pose. Rozerem will compete against drugs like Ambien and Lunesta, both of which list the potential for dependency in their labels.

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A new study has found that the sleep drug Ambien is safe to use long term.

The study -- released Wednesday at the Collegium Internationale Neuro-Psychopharmacologicum 25th Biennial Congress in Chicago -- showed Ambien Controlled-Release is "well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia when taken as needed for up to seven nights per week," Ambien maker Sanofi-Aventis said in a statement.

The data also showed patients in the study had no "rebound insomnia" following discontinuation of the drug.  The company said it studied Ambien CR in 1,018 adults for 25 weeks.

"These data are important for patients who experience chronic insomnia because they demonstrate there is a treatment option in Ambien CR that can be taken safely and effectively as needed long-term to help them both fall asleep and maintain sleep through the night," Tom Roth, director of the Sleep Disorders Center at Henry Ford Hospital in Detroit, said in a statement issued by the company.

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Melatonin is a hormone made by the pineal gland of the brain. It is believed that melatonin helps our brains to know when it is time to sleep. Melatonin supplements in pill form can also be taken and may be made from natural or synthetic melatonin. As natural melatonin is made from animals, it may be contaminated with a virus and should be avoided.

Melatonin can be used to treat insomnia and to prevent jet lag. There is still little scientific evidence to prove its role in preventing disease or promoting health.

Melatonin is sold without a prescription in the United States. However, melatonin products are not approved by the U.S. Food and Drug Administration. 

It may be better not to take melatonin until we know more about it. If you decide to try it, talk to your doctor first.

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Cypress Bioscience Inc. (CYPB.O) on Tuesday announced that it was discontinuing development for a treatment of obstructive sleep apnea. This decision followed  results of a mid-stage trial that found the results of the drug unsatisfactory.

Cypress and Organon, a unit of Akzo Nobel (AKZO.AS), had each independently conducted Phase IIa trials evaluating combinations of mirtazapine with another approved drug.

The companies are exploring other opportunities for collaboration, Cypress added.

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A recent study has found that antidepressant drugs may be linked to REM-sleep behavior disorder, also called RBD, that causes people to act out violent dreams. Experts say more tests are needed before the drugs should be stopped.

In a study led by Dr. R. Robert Auger from the Mayo Clinic, it was found that 80% of young people who have RBD took antidepressants, a higher percentage than people over 50, the typical age when RBD sets in.

Antidepressants have been found to affect the dream stage of sleep. Auger said it was possible that RBD is caused by the drugs or by the illness causing a person to take antidepressants. He said that he would not recommend ending antidepressants but possibly switching to a different kind. He also recommends that anyone with RBD symptoms see a sleep specialist and take safety precautions to make sure they don`t get hurt in bed.

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The Mayo Clinic article ‘Sleeping pills: A prescription for better sleep’ provides valuable information to those considering or taking sleeping pills. The article describes the different types of sleeping pills available, their side effects, precautions and considerations. Information about over-the-counter medications, Nonbenzodiazepine hypnotic medications, benzodiazepines and sedating antidepressants is provided in detail.

Valuable information is provided on the safe usage of sleeping pills:

• Check with your doctor:  Even if you decide to take over-the-counter medication, check with your doctor to make sure the sleeping pills won’t interact with other medications or medical conditions. Your doctor will recommend the right dosage, advise on prescription medication or further evaluation if needed.
• Take it one day at a time: Sleeping pills are a temporary solution and most over-the-counter varieties should be taken for only 2-3 nights at a time.
• Avoid alcohol: Never mix alcohol and sleeping pills as this can cause you to feel dizzy, confused or faint.
• Quit carefully: Follow doctor’s instructions or the instructions on the label when you need to stop. Some medications need to be stopped gradually.
• Watch for side effects: If you feel sleepy or dizzy during the day, report to your doctor.

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