[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

SCVNews.com | FDA Orders Maker of Ambien to Lower Recommended Doses | 01-10-2013
Inside
Weather
Santa Clarita CA
Cloudy
Cloudy
64°F
 
Calendar
Today in
S.C.V. History
August 20
1967 - New Town of Valencia dedicated; homes sell for $25,000 [story]


fdaThe U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.

The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate.”

In a Drug Safety Communication issued today, the FDA also reminded the public that morning impairment is not limited to zolpidem. Drowsiness is listed as a common side effect in the labels of all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. Moreover alertness can be impaired even in people who do not feel drowsy.

People who are currently taking the higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines should continue taking the prescribed dose as directed until discussing with their health care professional how to safely continue to take the medicine. Each patient and situation is unique, and the appropriate dose should be discussed with a health care professional. Patients should read the Medication Guide that comes along with their medication for additional information on the benefits and risks of these products.

The labeling change is based on findings in driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident.

“Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Dr. Unger. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”

The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (nonprescription) drugs.

Today’s safety communication provides a data summary, guidance for health care professionals, and advice for patients.

Health care professionals and the public can report side effects from the use of zolpidem or other medicines to FDA’s MedWatch program.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
Loading...
Related Content
LOCAL NEWS HEADLINES
Friday, Aug 18, 2017
Deputies Break Window, Rescue Dogs Locked in Car
Alerted by a concerned citizen Friday, Santa Clarita Valley Sheriff's Station deputies once again rescued dogs the owner left in a car with the windows rolled up and no water.
Friday, Aug 18, 2017
Environmental Groups File Complaint Against Newhall Ranch Water Plan
Two local environmental groups filed a complaint in L.A. Superior Court Thursday regarding the approved plan to provide water to the Newhall Ranch development, set to break ground in 2018.
Friday, Aug 18, 2017
SCV Sheriff’s Station Student Worker, LASD Dad Top Mt. Whitney
Ashley Olivier, a student worker at the Santa Clarita Valley Sheriff's Station, summited Mt. Whitney with her dad, a lieutenant at LASD's Monterey Park station.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
1967 - New Town of Valencia dedicated; homes sell for $25,000 [story]
1879 - Newhall civic leader Charles Henry Kingsburry born in Missouri [story]
Alerted by a concerned citizen Friday, Santa Clarita Valley Sheriff's Station deputies once again rescued dogs the owner left in a car with the windows rolled up and no water.
Deputies Break Window, Rescue Dogs Locked in Car
40 oz. to Freedom arrives in Santa Clarita as part of its anniversary tour at Concerts in the Park at Central Park on Saturday, August 19, with showtime at 7 p.m.
August 19: 40 Oz. to Freedom Rocks Central Park
Two local environmental groups filed a complaint in L.A. Superior Court Thursday regarding the approved plan to provide water to the Newhall Ranch development, set to break ground in 2018.
Environmental Groups File Complaint Against Newhall Ranch Water Plan
County Supervisor Kathryn Barger has provided $143,000 in funding to extend the season of youth and adult swim programs offered at the Castaic Aquatic Center through October 31.
Castaic Aquatic Center Programs Extended to October 31
Tonight on SCV NewsBreak, Los Angeles County firefighters and government leaders welcomed back the Super Scoopers Friday morning. Plus, the Old Town Newhall Library helped get the community ready for it as well by handing out free eclipse viewing glasses. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Friday, August 18, 2017
CalArts alumna Audrey Chan (Art MFA 07) will host a free, all-ages interactive arts workshop in Little Tokyo on Saturday and Sunday, August 19 and 20, as part of the Japanese American Cultural & Community Center’s 2017 Nisei Week activities.
August 19-20: Nisei Week Arts Workshop with CalArts Alum Audrey Chan
Western singer and songwriter John Zipperer headlines the next episode of "SCVTV Presents The OutWest Concert Series" at The MAIN in Old Town Newhall the evening of Friday, August 25.
August 25: John Zipperer Headlines ‘SCVTV Presents The OutWest Concert Series’
Habitat for Humanity SFV/SCV is honored to have received a $25,000 grant from the Disabled Veterans National Foundation, which will fund trauma workshops.
Habitat for Humanity Receives $25K Grant from Disabled Veterans
Here are agenda highlights for the next meeting of the Los Angeles County Board of Supervisors, set for Tuesday, August 22, starting at 9:30 a.m..
August 22: Board of Supervisors Meeting Agenda
Ashley Olivier, a student worker at the Santa Clarita Valley Sheriff's Station, summited Mt. Whitney with her dad, a lieutenant at LASD's Monterey Park station.
SCV Sheriff’s Station Student Worker, LASD Dad Top Mt. Whitney
Looking to enter the win column for the first time in 2017 on day two of the Summer Slam volleyball tournament, the TMU Mustangs squared off against 11th-ranked Eastern Oregon but lost in straight sets.
Mountaineers Spike Mustangs at Summer Slam
Caltrans has released "Rail and the California Economy," a research report investigating how the state’s vast passenger and freight rail system contribute to California’s economy, as well as an overview of opportunities for rail to address the state’s needs and challenges in the future.
New Report Details Rail Role in State Economy
The Master’s University women’s soccer team soared to a 7-0 victory over the visiting Eagles from Sierra Nevada College Thursday.
Lady Mustangs Soccer Win Opener 7-0
The Master’s University women's volleyball team concluded their first day of HIU Summer Slam tournament play with a five-set thriller against the Southern Oregon University Raiders on Wednesday evening, dropping the fifth set 15-9.
Lady Mustangs Fall in 5 to Raiders at HIU
A federal judge on Wednesday ruled against claims by a state workers’ union that California’s pension system unfairly changed the terms of a pre-existing collective bargaining agreement.
Court Upholds Increase in CalPERS Retirement Age
Friday's alert from the South Coast Air Quality Management District that air quality will be unhealthy for sensitive individuals in the Santa Clarita Valley has been extended through Saturday.
Updated: SCV Air Quality Unhealthy Saturday
Four annual crime reports, which provide law enforcement agencies and the public with statewide data on crime statistics, were released Friday by California's Attorney General.
AG Releases 4 California Crime Reports for 2016
The Master’s University women’s volleyball team lost their 2017 season opener Wednesday at the HIU Summer Slam in straight sets against the Warriors from national powerhouse Corban University (OR).
Warriors Drop TMU Lady Mustangs in Straight Sets
Here's the Castaic/Val Verde (Zone 2) Crime Information and Public Safety Report from the Santa Clarita Valley Sheriff's Station for the week of August 7 to August 13.
Crime Blotter: Assault, Theft in Castaic-Val Verde
Two Santa Clarita Valley Sheriff's Station employees will be recognized at the City Council meeting to be held on August 22 at 6 p.m.
City Council to Honor 2 SCV Sheriff’s Station Employees
The Santa Clarita Public Library invites residents to celebrate the upcoming total solar eclipse on Monday, August 21 with two free events at the Old Town Newhall Library.
August 18 & 21: Solar Eclipse Events at Newhall Library
The city of Santa Clarita’s Youth Sports program has seen measured success thus far in 2017.
Santa Clarita Youth Sports Program Sees Spike in Participation
The Santa Clarita Valley Senior Center’s new building campaign now only has $1.3 million remaining to raise before groundbreaking on the site can begin.
New SCV Senior Center Needs $1.3M to Break Ground
Sacramento County sued the California Department of Water Resources on Thursday over DWR's certification of the California 'WaterFix' delta tunnels project’s “dizzying” and “shifting” environmental review.
Sacramento County Sues to Freeze California ‘WaterFix’
1946 - Pioneering Placerita Canyon movie producer Trem Carr dies in San Diego [story]
' style=
The storewide remodel of the Walmart Supercenter at 26471 Carl Boyer Drive is complete and, in addition to the many physical changes inside, Santa Clarita residents now have access to Online Grocery Pickup.
Walmart on Carl Boyer Drive Celebrates Grand Reopening Friday
Tonight on SCV NewsBreak, two people have been hospitalized after a major collision. Plus, an acquisition of land near the 14. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Thursday August 17, 2017
Le Chene French Cuisine, a long-time Santa Clarita local favorite restaurant along Sierra Highway, has announced that they will be hosting a thrilling Murder Mystery Dinner on Saturday, November 4th, 2017.
Nov. 4: Le Chene Murder Mystery Dinner
Senator Scott Wilk, R- Antelope Valley, today announces that he is one of the 2017 inductees into the Antelope Valley High School Alumni Hall of Fame.
Sept. 22: Wilk to be Inducted into AV High School Hall of Fame
Signups are under way for the Santa Clarita Walk to End Alzheimer’s, which offers participants an opportunity to take a healthy stroll, experience outstanding live entertainment, honor loved ones who have been affected by Alzheimer’s and raise funds to battle the debilitating disease.
Oct. 7: Walk to End Alzheimer’s; Signups Under Way
Trammell Crow Company (TCC) andand Clarion Partners are pleased to announce the acquisition of 54 acres of land for the development of The Center at Needham Ranch, a state-of-the-art business park in the city of Santa Clarita, CA.
TCC, Clarion Partners Acquire More Than 50 Acres of SCV Real Estate
The California Department of Tax and Fee Administration is hosting what will be a highly educational and informative (and free) Tax Seminar for Nonprofits and Exempt Organizations.
Sept. 6: Tax Seminar for Non-Profits and Exempt Organizations