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FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program

Posted 31 Jan 2017 by Drugs.com

January 18, 2017 – The FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with narcolepsy have cataplexy. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy. The use of Xyrem has been associated with serious side effects including seizures, trouble breathing, changes in alertness, coma, and death. Additionally, the active ingredient in Xyrem (and in the newly approved generic) is sodium oxybate. Sodium oxybate is the sodium salt of ... Read more

Related support groups: Xyrem, Narcolepsy, Cataplexy, Sodium Oxybate

Brain Relies on Two Timekeepers for Sleep

Posted 12 Aug 2016 by Drugs.com

FRIDAY, Aug. 12, 2016 – Both an internal "clock" and an internal "hourglass" affect how different parts of your brain respond to sleep deprivation, a new study shows. The Belgian researchers said these findings could eventually aid in the understanding of sleep disorders, and help folks who work night shifts or those with jet lag. The study involved 33 healthy young people who volunteered to stay awake for 42 hours and have their mental sharpness tracked along the way. Sleep scientists from the University of Liege used MRI scans to chart the volunteers' brain activity as they performed tests of attention and reaction time. Not surprisingly, their performances dulled as their sleep deprivation worsened. But the brain scans revealed a complicated interaction between two basic biological processes: the body's central "circadian rhythm," which pushes people to be awake and active during ... Read more

Related support groups: Sleep Disorders, Insomnia, Fatigue, Nightmares, Drowsiness, Sleep Apnea, Narcolepsy, Shift Work Sleep Disorder, Night Terrors, Prevention of Cardiovascular Disease, Sleep Paralysis, Hypersomnia, Insomnia - Stimulant-Associated, Cardiovascular Risk Reduction, Cataplexy, Obstructive Sleep Apnea/Hypopnea Syndrome, Non-24-Hour Sleep Wake Disorder, Jet Lag, REM Sleep Behavior Disorder, Alcohol-Induced Sleep Disorder

Health Tip: Considering a Sleep Study?

Posted 21 Jul 2016 by Drugs.com

-- If you can't find a way to get to sleep, a sleep study may help you figure out what's behind your insomnia. The National Sleep Foundation says a sleep study may help if: Your doctor can't figure out what's causing your sleep problems. You've tried treatments for sleep issues without success. You have significant daytime drowsiness or chronic snoring. You wake up often throughout the night, or have trouble falling asleep. Read more

Related support groups: Sleep Disorders, Insomnia, Fatigue, Nightmares, Drowsiness, Sleep Apnea, Narcolepsy, Shift Work Sleep Disorder, Night Terrors, Sleep Paralysis, Hypersomnia, Insomnia - Stimulant-Associated, Cataplexy, Obstructive Sleep Apnea/Hypopnea Syndrome, Non-24-Hour Sleep Wake Disorder, Alcohol-Induced Sleep Disorder, REM Sleep Behavior Disorder

Sleep Disorders 6 Times Higher Among Veterans

Posted 20 Jul 2016 by Drugs.com

WEDNESDAY, July 20, 2016 – Sleep disorders are six times more likely among American military veterans than in the general population, a new study finds. And veterans with post-traumatic stress disorder (PTSD) seem to have the highest rates, the researchers said. The research involved more than 9.7 million veterans treated by the Veterans Health Administration system between 2000 and 2010. The majority (93 percent) of these military service members were men. Slightly more than 750,000 were diagnosed with at least one sleep disorder, the study authors said. Over the course of 11 years, the investigators found that the rate of sleep disorders rose from less than 1 percent to nearly 6 percent. Sleep disorders were most common among veterans who had experienced combat and those with PTSD. "Veterans with PTSD had a very high sleep disorder prevalence of 16 percent, the highest among the ... Read more

Related support groups: Sleep Disorders, Insomnia, Fatigue, Post Traumatic Stress Disorder, Nightmares, Drowsiness, Sleep Apnea, Narcolepsy, Night Terrors, Sleep Paralysis, Hypersomnia, Insomnia - Stimulant-Associated, Cataplexy, Obstructive Sleep Apnea/Hypopnea Syndrome, Alcohol-Induced Sleep Disorder

Sleepless Nights Linked to Brain Changes in Study

Posted 5 Apr 2016 by Drugs.com

TUESDAY, April 5, 2016 – Insomnia is linked with abnormalities in the brain's white matter – the tissues that form connections and carry information between different parts of the brain, a small Chinese study suggests. The researchers said these disruptions occur in areas of the brain involved in the regulation of sleep and wakefulness as well as cognitive function. The researchers explained that white matter tracts are bundles made up of long fibers of nerve cells that connect one part of the brain to another. "If white matter tracts are impaired, communication between brain regions is disrupted," said researcher Shumei Li. She's from the department of Medical Imaging at Guangdong No. 2 Provincial People's Hospital, Guangzhou, China. Although the study found an association between white tract matter abnormalities and insomnia, it wasn't designed to prove cause-and-effect. People with ... Read more

Related support groups: Sleep Disorders, Insomnia, Fatigue, Drowsiness, Sleep Apnea, Narcolepsy, Shift Work Sleep Disorder, Sleep Paralysis, Hypersomnia, Insomnia - Stimulant-Associated, Cataplexy, Diagnosis and Investigation, Obstructive Sleep Apnea/Hypopnea Syndrome, REM Sleep Behavior Disorder, Head Imaging

FDA Medwatch Alert: Xyrem (sodium oxybate): Drug Safety Communication - Warning Against Use With Alcohol or Drugs Causing Respiratory Depression

Posted 18 Dec 2012 by Drugs.com

ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided. The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death. BACKGROUND: Xyrem (sodium oxybate) is FDA-approved ... Read more

Related support groups: Xyrem, Narcolepsy, Cataplexy, Sodium Oxybate

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venlafaxine, Xyrem, sodium oxybate