header image

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

Inside
Weather


 
Calendar
Today in
S.C.V. History
September 19
1863 - Gen. Edward F. Beale loans money to A.A. Hudson and Oliver P. Robbins to erect toll house in Newhall Pass [story]
toll house


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
LOCAL NEWS HEADLINES
Wednesday, Sep 18, 2024
Sept. 21: JCI Invites All Veterans to Upcoming Resource Fair
JCI Santa Clarita is proud to announce the upcoming Veteran’s Resource Fair, scheduled to take place on Sept. 21 at William S. Hart Park. 
Tuesday, Sep 17, 2024
Sept. 19: SENSES Pirate Block Party
Get ready to set sail at the Pirates SENSES Block Party, presented by the city of Santa Clarita, Thursday, Sept 19 from 7-10 p.m. on main street in Old Town Newhall.
Tuesday, Sep 17, 2024
Foothill League Football Begins for SCV Teams
Six of the seven Foothill League Varsity football teams begin league play Friday night, Sept. 20.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
1863 - Gen. Edward F. Beale loans money to A.A. Hudson and Oliver P. Robbins to erect toll house in Newhall Pass [story]
toll house
The Counties of Los Angeles and San Bernardino today announced the opening of multiple joint Local Assistance Centers to assist residents impacted by the Bridge and Line Fires.
L.A., San Bernardino Counties to Open Joint Local Assistance Centers for Residents Impacted by Bridge and Line Fires
Valencia Gynecology Associates, owned by longtime Santa Clarita Valley OB-GYN physician Don Nishiguchi, MD, has joined the Henry Mayo Newhall Hospital network. 
Valencia Gynecology Assoc. Joins Henry Mayo Network
JCI Santa Clarita is proud to announce the upcoming Veteran’s Resource Fair, scheduled to take place on Sept. 21 at William S. Hart Park. 
Sept. 21: JCI Invites All Veterans to Upcoming Resource Fair
A "friendies" field tournament  is being  hosted by the Saugus Instrumental Music program, with support from Valencia High, later this month. 
Sept. 21: All Valley Showcase Comes to Valencia High
Public, member-supported 88.5 FM The SoCal Sound, Southern California’s leading Triple-A (adult album alternative) format radio station has announced the lineup for its inaugural “Year-End Bash” taking place on Saturday, Dec. 7.
Dec. 7: CSUN Owned 88.5-FM The SoCal Sound Announces “Year End Bash” Lineup featuring Ben Gibbard
The Master's University cross-country teams continued their successful 2024 campaigns with strong finishes at the BIOLA Invitational on Friday, Sept. 13 at Craig Regional Park in Fullerton, Calif.
TMU Women Win, Men Place Second at XC Invitational
Sheriff’s Department Announces New Law Enforcement Gang Policy
Sheriff’s Department Announces New Law Enforcement Gang Policy
The biology department at California State University, Northridge has stayed committed to promoting STEM research carried out by K-12 students and teachers in the Los Angeles Unified School District.
CSUN Student Research Journal Celebrates 28 Years of Inspiring Scientific Imagination
Did you know the SCVEDC has an interactive, online tool that provides themed virtual tours of the amazing features the community has to offer? 
Take a Virtual Tour of the Santa Clarita Valley
California Institute of the Arts alum and visionary filmmaker Tim Burton (Film/Video 1979) was honored with the 2,788th star on the Hollywood Walk of Fame.
CalArts Alum Tim Burton Receives Star on Hollywood Walk of Fame
1962 - Articles of incorporation filed for Golden State Memorial Hospital on Lyons Avenue [story]
Golden State Hospital
The Santa Clarita Valley Senior Center welcomes back Jim Curry for an evening concert celebrating the music of John Denver on Saturday, Oct. 5 at 5 p.m. in the Grand Ballroom at Bella Vida.
Oct. 5: SCV Senior Center Welcomes Jim Curry ‘Take Me Home’
As part of the Santa Clarita Valley Water Agency's ongoing commitment to ensuring local groundwater quality and reliability, the SCV Water recently began construction on a new treatment facility to remove perchlorate and volatile organic compounds at Well 205 in Valencia.
SCV Water Begins New Water Treatment Project in Valencia
Get ready to set sail at the Pirates SENSES Block Party, presented by the city of Santa Clarita, Thursday, Sept 19 from 7-10 p.m. on main street in Old Town Newhall.
Sept. 19: SENSES Pirate Block Party
No. 21 College of the Canyons football team knocked off No. 5 Fullerton College 29-13 on Saturday night behind a stifling defensive effort and five field goals from Luis Rodriguez.
No. 21 Canyons Knocks Off No. 5 Fullerton 29-13
Six of the seven Foothill League Varsity football teams begin league play Friday night, Sept. 20.
Foothill League Football Begins for SCV Teams
The California Institute of the Arts will present the "NAACP Santa Clarita Masquerade Ball", Friday, Oct. 4, 7-11 p.m. at 24700 McBean Parkway, Valencia, CA 91355.
Oct. 4: NAACP Santa Clarita Masquerade Ball at Cal Arts
The Los Angeles County Department of Public Health is investigating two human cases of a rare parasitic infection, Baylisascaris procyonis, also known as raccoon roundworm.
Public Health Investigating Disease Spread from Animals to Humans
1879 - First official Newhall School building erected near Walnut & Ninth streets [story]
First Newhall School
The city of Santa Clarita is hosting Make A Difference Day on Saturday, Oct. 26 and is looking for enthusiastic residents to volunteer for various projects that benefit local nonprofits, as well as the city.
Oct. 26: Volunteers Needed for Make a Difference Day
Henry Mayo Newhall Hospital and PathPoint announced the graduation of Aiden Land and Andrew Mendence from the Project SEARCH internship program.
Henry Mayo Newhall Hospital, PathPoint Celebrate Grad Interns
The William S. Hart Union High School District has announced upcoming community information meetings about Learning Post Academy Independent Study School, Thursday, Sept. 18 and Friday, Sept. 19.
Sept. 18-19: Learning Post Academy Online Information Meetings
The Santa Clarita Community College District Board of Trustees will hold a special meeting Wednesday, Sept. 18, 5 p.m. in open session to interview and appoint a new trustee for Area 5.
Sept. 18: COC Board to Interview, Appoint Area 5 Trustee
SCVNews.com