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
  • 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.

  • Steps to Conduct a JSA

    We've put together a comprehensive step-by-step guide to help you perform a job safety analysis (JSA), which includes a pre-built, JSA checklist and template, steps of a JSA, list of potential job hazards, and an overview of hazard control hierarchy.

  • Everything You Need to Know about Incident investigations

    Need some tips for conducting an incident investigation at work after there’s been an occupational injury or illness, or maybe even a near miss? This guide presents a comprehensive overview of methods of performing incident investigations to lead you through your next steps.

  • 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.

  • Industry Safe
Bulwark CP

OH&S Digital Edition

  • OHS Magazine Digital Edition - October 2020

    October 2020

    Featuring:

    • FACILITY SECURITY
      EHS Compliance: Make it Personal
    • FOOT PROTECTION
      Choosing the Right Safety Shoe for Your Industry
    • HAND PROTECTION
      A Requirements Checklists for Work Safety Gloves
    • COVID-19 MANAGEMENT
      Contemporary Issues in HSE Management
    View This Issue