FDA lowers current recommended starting dosage on Rx sleep remedy Lunesta
SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose. 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.
Taken at bedtime, the recommended starting dose of Lunesta (eszopiclone) has been decreased 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. Using lower doses means less drug will remain in the body in the morning hours.
Patients currently taking the 2-mg and 3-mg doses of Lunesta should contact their healthcare professional to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.
“To help ensure patient safety, healthcare professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” said Ellis Unger, director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “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.”
The dose change is based, in part, on findings from a study of 91 healthy adults ages 25 yeras to 40 years. The study shows, compared to an inactive pill (i.e., placebo), Lunesta 3 mg was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. 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 approved changes to the Lunesta prescribing information and the patient Medication Guide to reflect these new prescribing recommendations. The drug labels for generic eszopiclone products also must be updated to include these changes. In a drug safety communication issued today, the FDA urged healthcare professionals to caution patients taking Lunesta about the risk of next-morning impairment for activities that require mental alertness, including driving. Alertness can be impaired even in people who do not feel drowsy.
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 stated.
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 of next-morning impairment.
Report: Less than half of Hispanic patients have diabetes under control
LAS VEGAS — A multi-year medical research study released Thursday that examined health issues among U.S. Hispanic/Latino groups has yielded data indicating that less than half of the participants diagnosed with diabetes had the condition under control.
“As a group, approximately one-third of Hispanics with the disease do not know they have diabetes,” stated Larissa Aviles-Santa, the study’s project director and Medical Officer with the National Heart, Lung, and Blood Institute’s Division of Cardiovascular Sciences. “So there is an opportunity here to take a look at clinical practices and think about how we can enhance guidelines and raise awareness amongst the Hispanic community.”
The study also revealed significant differences in the prevalence of diabetes across Hispanic groups: the disease was more common among those of Mexican, Puerto Rican and Dominican origin and least prevalent among those from South America. “This shows that talking about Hispanics as a group can be misleading,” Aviles-Santa said. “I would encourage educators and clinicians to consider Hispanics as not just one culture and one mentality, but a whole spectrum.”
The Hispanic Community Health Study/Study of Latinos, spearheaded by the National Heart, Lung, and Blood Institute, recruited and examined more than 16,000 participants in four cities from 2008 to 2011 to identify risk factors that play a role in the development of cardiovascular and other diseases in Hispanics/Latinos, the largest ethnic minority group in the United States. The study is ongoing.
The data was presented before the American Association of Clinical Endocrinologists’ 23rd Annual Scientific and Clinical Congress.
Characters from ‘Star Wars’ and ‘Frozen’ get starring roles in new Jelly Belly collections
FAIRFIELD, Calif. — Jelly Belly Candy Co. is giving consumers a mix of whimsical fantasy and iconic sci-fi with its latest additions, which includes two of Hollywood’s biggest blockbuster films — "Star Wars" and "Frozen."
The Star Wars collection contains three 1-oz. bags and a 2.8-oz. Grab & Go bag, and each bag is filled with a "galaxy mix" of Jelly Bell beans. The mix is comprised of: Sparkling Berry Blue, Sparkling Blueberry, Sparkling Green Apple, Sparkling Sour Apple and new flavors Sparkling Grape Soda, Sparkling Wild Blackberry and Sparkling Island Punch.
The 1-oz. bag features images of a Stormtrooper, Darth Vader and Yoda. Consumers looking for more galactic flair can choose the 2.8-oz Grab & Go, which features the iconic Darth Vader (wielding a red lightsaber, of course). Both 1-oz. and 2.8-oz. bags are available beginning June 2014.
The Frozen collection, modeled after Disney’s recent hit animated film, contains an Icicle mix and includes flavors like: Sparkling Berry Blue, Sparkling Blueberry, Sparkling Cream Soda and the new Sparkling Grape Soda flavors. The 1-oz. bags, available to retailers in June, feature Queen Elsa, Princess Anna and Olaf the snowman. The 2.8-oz. Grab & Go bag features the three aforementioned characters linking arms. The Grab & Go bag is available beginning in July.
The company also announced a Frozen gift bag, which comes in a shimmering periwinkle-colored packaging and features the three main characters. The gift bag is filled with 7.5-oz of the Icicle mix and is available in August.