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FDA Cuts Sleep Aid Dosage in Half among Side Effect Concerns

In an attempt to combat next-morning impairment caused by several brands of sleep aids, the Food and Drug Administration has slashed the recommended dosage of Lunesta in half to one milligram. This is just the latest in a move to combat numerous dangerous side effects caused by the potent medications including Lunesta and its competitor Ambien. The FDA lowered the dose further from its original recommendation of two milligrams and advised its manufacturer, Sunovion Pharmaceuticals to reflect this change on the label.

The smaller dose reduces the amount of the powerful drug left in the patients’ bloodstream in the morning. The FDA aims to eliminate the dangerous side effects that may impair a patient’s ability to drive or operate machinery while taking a prescription sleep aid. The New York Times as well as several other news outlets alleges the change came in part from the result of a British study on 91 subjects in 2012. The study concluded that patients who consumed three milligrams of Lunesta experienced “severe impairment of memory and motor skills the morning after taking the drug, compared with a placebo.” The study also found the earlier prescribed dose of two milligrams, which was thought to be safe, can still “hamper driving, memory and coordination for up to 11 hours after the drug was taken.” Researchers found that most of the patients did not know or realize that they were actually impaired, potentially creating an extremely dangerous situation.

The New York Times reports that, “According to IMS Health, a health care services company, about 55 million prescriptions for sleep aids were dispensed in the United States in 2013.” In January of last year, the FDA also recommended the dosage for Ambien and all other sleep aids containing the active ingredient zolpidem should be cut in half especially when prescribed to women.

Side effects of sleep medications have been in the spotlight in recent years, as we continue to learn more about both the drugs and the human brain.

Side effects for Ambien and Lunesta include:
• drowsiness
• dizziness
• diarrhea
• grogginess or feeling as if you have been drugged • uncontrolled crying
• vomiting
• stomach cramps
• panic attack
• nervousness • Abnormal thoughts or behavior • Memory loss • Severe allergic reaction (swelling of the tongue or throat, and trouble breathing.)
• Unpleasant taste in your mouth, dry mouth (Lunesta)
(Source: Lunesta.com and the FDA)

The most serious side effect for both of the most popular sleep aids is of particular cause for concern. The FDA warns that, “You may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.” An almost identical warning is posted on the Lunesta website. Activities could include driving or operating dangerous machinery, talking on the phone, sleep-walking, and others. As many officials are beginning to crack down on distracted driving, it is easy to understand why the FDA believes this medication may be dangerous if left in the bloodstream when patients attempt to complete daily activities, completely unaware that they are actually dangerously impaired.

Dr. Daniel J. Carlat, an associate clinical professor of psychiatry at Tufts University confirms to the New York Times, “Lower doses can prevent next-day sleepiness and head off big problems, like car accidents.”

If you or a loved one has been injured by a dangerous side effect, or has been in a motor vehicle accident as a result of drowsy driving caused by a sleep aid, you are urged to contact an attorney right away. At the Greater Boston Law Firm of Altman & Altman, LLP, our dedicated team of Massachusetts Personal Injury Attorneys have decades of experience helping victims of even the most complex pharmaceutical cases. Our attorneys combine the professional expertise of having successfully handled thousands of Personal Injury cases, with the individual attention to understand and respond to the unique nature of your case. We will look into every detail of your case and will explore every legal avenue available in order to deliver legal representation of the highest quality.

At the law offices of Altman & Altman, we are available 24 hours a day, seven days a week – including nights and weekends to answer any questions regarding your case. Call us today to schedule a free initial consultation and case evaluation.

Read more The New York Times

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