FDA Requires Lower Doses For Ambien, Other Sleep Medications
WASHINGTON (CBSNewYork/AP) — The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.
The agency said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with morning driving, which increases therisk of car accidents.
Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly. Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.
The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.
“Some of my patients report that they wake up in the middle of the night eating, walking, talking and things like that with Ambien,” Dr. Vicki Seelall told CBS 2’s Dana Tyler.
The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under brands including Ambien, Edluar and Zolpimist.
FDA officials say doctors should aim to prescribe the lowest dose possible that will successfully treat insomnia.
“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,” said Dr. Ellis Unger, a director in FDA’s Office of Drug Evaluation.
Unger said in a statement that the FDA has received a number of reports of car accidents connected to zolpidem over the years. However, the agency did not have enough information to tell how much of a role the drug played in the incidents.
Patrick Kennedy, a former Rhode Island congressman, said he was asleep when he crashed his car in 2006. He blamed the crash on Ambien.
The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving.
For now, patients should continue taking their currently prescribed dose until they can talk to their doctor about the best way to proceed.
Ambien is sold by Sanofi, Edluar by Meda Pharmaceuticals Inc. and Zolpimist by NovaDel Pharma Inc.
Also Thursday, Mayor Michael Bloomberg’s Task Force on Prescription Painkiller Abuse issued new rules to prevent prescription drug abuse in the city’s 11 public emergency rooms.
Under the new guidelines, doctors can only prescribe up to a three-day supply of opioids to ER patients in the city’s public hospitals. Emergency departments will also no longer prescribe long-acting opioid painkillers.
Refills will not be given for lost, stolen or destroyed prescriptions for the drugs.
“The number of painkiller-related emergency room visits in our city has increased by 143 percent,” Bloomberg said while announcing the new guidelines at Elmhurst Hospital in Queens.
The new rules are voluntary but recommended for private hospitals, the city announced.
“Prescription painkillers can provide life-changing relief for people in dire health situations, but they can be extremely dangerous if used or prescribed improperly,” said Bloomberg. “Working with health care providers and public health criminal justice experts our task force is providing the tools to fight a burgeoning epidemic while protecting legitimate health care needs. Together we are committed to addressing the violent impact that drug abuse is having on individuals and communities.”
There will also be an awareness campaign to help cut down on prescription drug abuse. Posters in four languages will go up in public hospital ERs with tips on how to reduce unintended harms of opioid painkillers.
Opioid painkillers include: oxycodone (e.g. OxyContin, Roxicodone), hydrocodone (e.g. Vicodin), morphine, fentanyl patches and methadone.
The goal of the new guidelines, according to the city, is to reduce prescription drug abuse by limiting the supply of the drugs. Three out of four people who abuse prescription pain killers do so through leftover medications, according to the task force.
The task force’s report also led to the creation of NYC RxStat, a database that will compile relevant public health and public safety data to combat prescription painkiller abuse.
“Prescription opioid painkillers can be just as dangerous as illegal drugs,” said Health Commissioner Thomas Farley. “These new guidelines will help reduce prescription drug misuse while also making sure that patients coming to emergency departments have access to safe and appropriate pain relief options.”
The Mayor’s Task Force on Prescription Painkiller Abuse began in December 2011.
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