FDA Requires Lower Lunesta Starting Dose

The agency has announced it will be requiring a lower starting dose for the sleep drug

The FDA has announced it will be requiring the manufacturer of Lunesta (eszopiclone), a sleep drug, to lower the current recommended starting dose on the drug’s label. According to a report from the FDA, data has shown that eszopiclone levels in some patients may be high enough the morning after use that they could impair activities that require alertness. Patients may feel fully awake but actually be impaired.

The recommended dose has been lowered from 2 mg to 1 mg for both men and women. The drug’s dose can be increased to 2 or 3 mg, though a higher dose is more likely to result in next day impairment. The change in dose comes as a result of a recent study that followed 91 healthy adults ages 25-40. The study showed that Lunesta 3 mg, when compared to a placebo pill, was associated with “severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug.”

“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,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, in the FDA’s press release. “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.”

Current Lunesta users taking 2 or 3 mg should consult their health care professional for next step instructions. 

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue