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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on May 15, 2014, at 18:05:31
ews Alerts > Medscape Medical News
FDA Cuts Starting Dose of Eszopiclone (Lunesta) in Half
Megan BrooksDisclosures
May 15, 2014
FDA Label Changes for Zolpidem ProductsThe US Food and Drug Administration (FDA) has lowered the recommended starting dose of the sleep aid eszopiclone (Lunesta, Sunovion Pharmaceuticals Inc) effective immediately, the agency announced today.
"Data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake," the FDA said in a statement.
The agency decreased the recommended starting dose of eszopiclone from 2 mg to 1 mg for both men and women.
"The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness," the FDA said.
"To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia," Ellis Unger, MD, director, Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, said in the statement.
"Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs," Dr. Unger added.
The dose decrease is based, in part, on a study of 91 healthy adults aged 25 to 40 years. The study found that eszopiclone, 3 mg, was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after they took the drug, compared with placebo.
"The study found that recommended doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken. Despite these long-lasting effects, patients were often unaware they were impaired," the FDA said.
The Lunesta prescribing information (label) and patient Medication Guide will reflect the new recommended starting dose. The drug labels for generic eszopiclone products will also be updated to include these changes.
In a drug safety communication, the FDA urges healthcare professionals to caution patients taking eszopiclone about the risk for next-morning impairment for activities that require mental alertness, including driving. Alertness can be impaired even in people who do not feel drowsy.
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"The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter drugs, and will update the public as new information becomes available," the agency said.In January 2013, the FDA announced a dose reduction for sleep drugs that contain the active ingredient zolpidem, such as Ambien and Ambien CR, because of the risk for next-morning impairment, as reported by Medscape Medical News.
Adverse reactions or quality problems experienced with these products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Posted by alexandra_k on May 15, 2014, at 18:14:17
In reply to FDA cuts Starting Dose of Lunesta From 2 to 1 mg, posted by Phillipa on May 15, 2014, at 18:05:31
i guess they didn't figure that out earlier because rats don't drive?
Posted by Beckett on May 15, 2014, at 18:43:59
In reply to FDA cuts Starting Dose of Lunesta From 2 to 1 mg, posted by Phillipa on May 15, 2014, at 18:05:31
Interesting. I was given 3 mg. out the gate. Now I use Sonata which is not as strong, but when taken early enough does not produce a hangover that interferes with morning activities like driving.
:) to Alexanda
Posted by Phillipa on May 15, 2014, at 20:15:01
In reply to Re: FDA cuts Starting Dose of Lunesta From 2 to 1 mg, posted by Beckett on May 15, 2014, at 18:43:59
Beckett I also took 3mg add benzos and didn't feel drugged at all. Guess this shows the level of my anxiety. Phillipa
Posted by ed_uk2010 on May 16, 2014, at 16:54:16
In reply to Re: FDA cuts Starting Dose of Lunesta From 2 to 1 mg » Beckett, posted by Phillipa on May 15, 2014, at 20:15:01
Over here, we use zopiclone (Zimovane), not eszopiclone (Lunesta). The standard adult dose of zopiclone is 7.5mg, equivalent to 3.75mg of eszopiclone.... which is above the maximum recommended dose of Lunesta!
I think our regulatory authorities should consider making 3.75mg zopiclone the new starting dose (equivalent to 1.875mg of eszopiclone). We only have 3.75mg and 7.5mg zopiclone tablets, so there isn't as much room for titration as with Lunesta. The advantage of zopiclone is that it's dramatically less expensive. At the moment, 3.75mg is only used as a starting dose for older people or those who have previously shown sensitivity to sedative meds. It would be useful if a company would launch a lower strength of tablets. This would be helpful as a starting dose, for the 'med sensitive', for anyone requiring early morning alertness and for people tapering off the med to avoid withdrawal symptoms.
This is the end of the thread.
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