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FDA: Lower Ambien's Dose to Prevent Drowsy Driving

Posted 6 days ago by Drugs.com

WEDNESDAY, May 15 – The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard while performing certain tasks such as driving. The move follows the FDA's request to manufacturers in January that drugs containing zolpidem carry instructions that lower the recommended dose and provide more safety information to patients. "FDA has approved these changes because of the known risk of next-morning impairment with these drugs," the agency said in a statement released Tuesday on its website. Sleep medications containing zolpidem include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR. "The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," Dr. Ellis ... Read more

Related support groups: Sleep Disorders, Insomnia, Ambien, Zolpidem, Ambien CR, Intermezzo, Edluar, Zolpimist

FDA Medwatch Alert: Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Posted 7 days ago by Drugs.com

Including Ambien, Ambien CR, Edluar, and Zolpimist  [UPDATE 05/14/2013] Today, the U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs. [Posted 01/10/2013] ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, ... Read more

Related support groups: Insomnia, Ambien, Zolpidem, Ambien CR, Intermezzo, Edluar, Zolpimist

Insomnia Hints at Future Hospitalization

Posted 11 days ago by Drugs.com

FRIDAY, May 10 – If you have trouble sleeping at night, you may be headed for more than just frustration and fatigue: Middle-aged and older adults with insomnia are more likely to be hospitalized and use home health care services, a new study suggests. Preventing insomnia in this group of people could reduce their use of health services by anywhere from 6 percent to 14 percent, according to the researchers from Johns Hopkins Bloomberg School of Public Health. The researchers looked at U.S. national data on insomnia symptoms and health-services use among nearly 14,400 middle-aged and older adults. They found that more than 40 percent of the study participants reported at least one insomnia symptom, such as trouble falling asleep, waking up during the night, and waking up too early and not being able to fall asleep again. The researchers said they found a significant association between ... Read more

Related support groups: Insomnia

ER Visits Tied to Ambien on the Rise

Posted 1 May 2013 by Drugs.com

WEDNESDAY, May 1 – There has been a dramatic increase in the number of emergency-room visits related to sleep medications such as Ambien, according to a new U.S. study. Adverse reactions to zolpidem – the active ingredient in the sleep aids Ambien, Ambien CR, Edluar and Zolpimist – rose almost 220 percent between 2005 and 2010, researchers from the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) found. The study authors concluded that use of these drugs for the short-term treatment of insomnia should be carefully monitored. Zolpidem, which has been approved by the U.S. Food and Drug Administration, has been used safely and effectively by millions of Americans, but adverse reactions to the medication have increased. Most of these cases involved people aged 45 and older, the researchers said. "Although short-term sleeping medications can help patients, it is ... Read more

Related support groups: Sleep Disorders, Insomnia, Ambien, Zolpidem, Ambien CR, Substance Abuse, Intermezzo, Edluar, Zolpimist

Health Tip: What's Keeping Your Child Awake?

Posted 15 Apr 2013 by Drugs.com

-- Insomnia is often thought of as an adult problem. But children, too, can have sleepless nights. The Nemours Foundation offers these potential causes for childhood insomnia: Being afraid of the dark. Having nightmares or bad dreams. Feeling stressed out or anxious about school or home life. Going through a major change in life, such as parents getting a divorce, moving, an illness or a death in the family. Being uncomfortable in some way, such as being too hot or too cold, hungry or too crowded in bed. Read more

Related support groups: Insomnia

Health Tip: Poor Sleep Can Hurt Your Heart...

Posted 2 Apr 2013 by Drugs.com

-- When you're not sleeping well, your whole body can suffer – including your heart. The Women's Heart Foundation explains how sleep disturbances may affect heart health: Increased stress. Increased hunger, resulting weight gain. Increased risk of stroke, as a possible result of sleep apnea. Increased risk of heart disease, as a possible result of sleep apnea. High blood pressure, faster heart rate and irregular heartbeat. Read more

Related support groups: Sleep Disorders, Insomnia

Insomnia Might Boost Heart Failure Risk

Posted 6 Mar 2013 by Drugs.com

WEDNESDAY, March 6 – Insomnia may triple the risk of developing heart failure, a large new study from Norway suggests. Heart problems definitely lead to sleep problems, said lead researcher Dr. Lars Laugsand, but his team tried to determine whether the reverse might also be true. "Insomnia is a frequent and easily recognized, potentially manageable and treatable condition," said Laugsand, a postdoctoral fellow in the department of public health at the Norwegian University of Science and Technology, in Trondheim. Laugsand added that the researchers found an association between insomnia and heart failure, not that insomnia actually causes heart failure. "We still do not know whether heart failure is really caused by insomnia, and it is still unclear why insomnia is linked to higher heart failure risk," he said. Heart failure is a chronic condition in which the heart does not pump blood ... Read more

Related support groups: Insomnia, Heart Failure, Congestive Heart Failure

Certain Sleep Aids May Raise Hip Fracture Risk in Nursing Homes: Study

Posted 4 Mar 2013 by Drugs.com

MONDAY, March 4 – Health staff at nursing homes often give patients sleeping pills to help them sleep, but a new study suggests that a certain class of medications may put patients at raised risk for hip fractures. A team from Harvard Medical School in Boston looked at more than 15,500 long-stay nursing-home residents, aged 50 and older, who suffered a hip fracture between July 2007 and December 2008. The residents' average age was 81. About 1,700 of the residents had been given a nonbenzodiazepine hypnotic sleep drug before their hip fracture. This class of drugs includes Lunesta, Sonata, Ambien and Intermezzo. Those who took nonbenzodiazepine hypnotic sleep drugs were about two-thirds more likely to suffer a hip fracture than those who didn't take the drugs, according to the study, published online March 4 in the journal JAMA Internal Medicine. Although the study found an association ... Read more

Related support groups: Sleep Disorders, Insomnia, Ambien, Zolpidem, Lunesta, Ambien CR, Sonata, Zaleplon, Intermezzo, Eszopiclone, Fracture, Edluar, Zolpimist

FDA Medwatch Alert: Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Posted 11 Jan 2013 by Drugs.com

Including Ambien, Ambien CR, Edluar, and Zolpimist    [Posted 01/10/2013] ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. P ... Read more

Related support groups: Insomnia, Ambien, Zolpidem, Ambien CR, Intermezzo, Edluar, Zolpimist

FDA: Lower Ambien's Dose to Prevent Drowsy Driving

Posted 10 Jan 2013 by Drugs.com

THURSDAY, Jan. 10 – The U.S. Food and Drug Administration announced Thursday that it is asking manufacturers of sleep medications containing zolpidem – including Ambien – to lower the recommended doses and to provide more safety information to patients. These sleep medications include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR. Officials are concerned that blood levels of zolpidem are high enough the morning after taking the drugs to continue to impair one's ability to perform certain activities. "The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," said Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research. "We're particularly concerned about driving. A large fraction of the population drives and driving ... Read more

Related support groups: Sleep Disorders, Insomnia, Ambien, Fatigue, Zolpidem, Ambien CR, Intermezzo, Edluar, Zolpimist

Many Americans Drive While Drowsy: Report

Posted 3 Jan 2013 by Drugs.com

THURSDAY, Jan. 3 – Driving drowsy is a major factor in traffic accidents and deaths in the United States, federal health officials reported Thursday. Federal statistics state that 2.5 percent of fatal motor vehicle crashes and 2 percent of crashes with non-fatal injuries involve drowsy driving. But, data gathering methods make it difficult to estimate the actual number of accidents that involve drowsy drivers. In fact, some studies have estimated that between 15 percent and 33 percent of fatal crashes may involve sleepy drivers. And deaths and injuries are more likely in motor vehicle crashes that involve drowsy driving, the report stated. According to the report by the U.S. Centers for Disease Control and Prevention, more than 4 percent of drivers quizzed said they had driven while drowsy in the month before the survey. "One out of 25 people reported falling asleep while driving in ... Read more

Related support groups: Sleep Disorders, Insomnia, Sleep Apnea

Experimental Insomnia Drug Shows Promise

Posted 28 Nov 2012 by Drugs.com

WEDNESDAY, Nov. 28 – A new insomnia drug helped people get a bit more shut-eye in a lab study, researchers report. The drug, known as suvorexant, is being developed by Merck Research Laboratories, which funded and conducted the study. The medication is not available yet, but the U.S. Food and Drug Administration is reviewing it for possible approval, the researchers said. In the United States, about 10 percent of people say they have chronic insomnia, according to the U.S. Centers for Disease Control and Prevention. There are sleep aids on the market, but they do not work for everyone and they can have side effects that include sleepwalking, daytime drowsiness and confusion. Suvorexant works differently from those drugs, zeroing in on specific brain chemicals involved in the ability to sleep, explained study author Dr. William Herring, executive director of clinical research at Merck. ... Read more

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Energy Drinks Disrupting U.S. Soldiers' Sleep: CDC

Posted 8 Nov 2012 by Drugs.com

THURSDAY, Nov. 8 – Energy drinks can cause sleep problems and daytime sleepiness among U.S. soldiers in combat zones, a new government study says. Army researchers looked at soldiers deployed in Afghanistan in 2010 and found that 45 percent of them consumed one or more energy drinks a day and 14 percent consumed three or more a day. Compared to those who consumed two or fewer energy drinks per day, soldiers who consumed three or more energy drinks a day were more likely to get four hours or less of sleep per night. They were also more likely to report sleep disruptions related to personal or combat stress and illness, and to fall asleep during briefings or while on guard duty. The study was published in the Nov. 9 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report. High-caffeine energy drinks are becoming increasingly popular among U.S. ... Read more

Related support groups: Sleep Disorders, Insomnia, Caffeine, Alert, NoDoz, Stay Alert, Vivarin, No Doz, Valentine, NoDoz Maximum Strength, Stat Awake, Caffedrine, Enerjets, Verv, Lucidex

Losing Weight May Improve Sleep Quality

Posted 6 Nov 2012 by Drugs.com

TUESDAY, Nov. 6 – Losing weight can help people who are overweight get a better night's sleep, according to a new study. And sleep quality seems to improve whether the weight loss is achieved through dieting alone or by combining diet with exercise, researchers from Johns Hopkins found. "We found that improvement in sleep quality was significantly associated with overall weight loss, especially belly fat," the study's senior author, Kerry Stewart, a professor of medicine at the Johns Hopkins University School of Medicine and director of clinical and research exercise physiology, said in a Hopkins news release. The study involved 77 overweight or obese people with type 2 diabetes or pre-diabetes. The participants were divided into two groups: those who dieted to achieve weight loss, and those who dieted and also exercised. The participants also completed a sleep survey at the beginning ... Read more

Related support groups: Insomnia, Obesity

Study Links Insomnia to $31 Billion in U.S. Workplace Errors

Posted 1 Oct 2012 by Drugs.com

MONDAY, Oct. 1 – Feeling sleepy on the job and having trouble focusing? It could cost you – and the nation as a whole. A new study estimates that insomnia is responsible for 274,000 workplace accidents and errors each year, adding up to $31 billion in extra costs. The research isn't conclusive, and it's possible that some factors other than sleeplessness may explain these mishaps. The findings also depend on the possibly hazy recollections of several thousand workers about things that happened to them over the past year. Still, the study does suggest a link between lack of sleep and problems in the workplace. The findings could encourage workplaces to pay more attention to insomnia and screen employees for the condition, said lead author Victoria Shahly, a clinical psychologist and instructor at Harvard Medical School in Boston. "Accidents and errors directly affect the corporate ... Read more

Related support groups: Insomnia

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Night Terrors, Insomnia - Stimulant-Associated, Nightmares, Sleep Disorders

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gabapentin, Ambien, Ativan, clonazepam, trazodone, amitriptyline, lorazepam, Elavil, mirtazapine, view more... Zyprexa, zolpidem, melatonin, temazepam, diphenhydramine, Lunesta, Tylenol PM, Restoril, doxepin, phenobarbital, quetiapine, Ambien CR, oxazepam, olanzapine, 5-HTP, Unisom, tryptophan, valerian, Halcion, Advil PM, Silenor, triazolam, doxylamine, Sonata, Rozerem, Zyprexa Zydis, Dalmane, Simply Sleep, 5-hydroxytryptophan, Endep, zaleplon, chloral hydrate, Sominex, Seconal, Excedrin PM, Nytol, Intermezzo, eszopiclone, estazolam, flurazepam, secobarbital, Sleepinal, Nightime Sleepaid, lavender, Edluar, Somnote, Prosom, Midol PM, Bio-Melatonin, Sleep Tabs, Seconal Sodium, butabarbital, Percogesic Extra Strength, Headache Relief PM, quazepam, pentobarbital, Melatonin Time Release, VesPro Melatonin, Acetadryl, SGard, Doans PM, Health Aid Melatonin, Motrin PM, Aldex AN, Tryptan, Seconal Sodium Pulvules, Aldex AN Chewable, Doxytex, Zolpimist, Aminomine, 40 Winks, aspirin/diphenhydramine, amobarbital, Vanatrip, Sleep Tab II, Doral, Medi-Sleep, ramelteon, diphenhydramine/magnesium salicylate, diphenhydramine/ibuprofen, Aquachloral Supprettes, Sleep-Eze-3, Somnicaps, Genapap PM, Mapap PM, acetaminophen/diphenhydramine, Legatrin PM, Unisom with Pain Relief, Nytol Maximum Strength, Sleep-ettes, Nytol Caplet, Twilite, Anacin PM Aspirin Free