Eszopiclone (LUNESTA): Too Dangerous at Any Dose

On May 15, the Food and Drug Administration (FDA) warned that the sleep drug eszopiclone (LUNESTA) could lead to potentially dangerous mental and physical impairment for more than 11 hours following a 3 milligram (mg) dose.[1] The FDA recommends lowering the starting dose from 2 mg to 1 mg, but that is a dangerously misguided solution, as even a 1 mg dose poses unacceptable risks.

Eszopiclone’s risks, like those of most other pharmaceutical sleep aids, remain too high at any currently available dose to justify taking the medication. When the FDA approved eszopiclone for insomnia in 2004, its own scientists objected, noting that animal studies suggested eszopiclone could cause cancer in humans.[2] At the time, Public Citizen’s Health Research Group warned Worst Pills, Best Pills News subscribers of the drug’s dangers and classified eszopiclone as a Do Not Use drug.[3] We maintain this position, especially in light of the results from the study that prompted the FDA’s latest warning.

Increased risk

Use of the “Z-drug” class of sleep medicines, to which eszopiclone belongs, is associated with increased adverse events — most notably, death.

A recently published study in the United Kingdom found that patients using Z-drugs were 3.2 times more likely to die from any cause in the first year after starting the drugs than those not taking the medications.[4]

Also, like other members of the Z-drug class, eszopiclone causes dangerous mental and physical impairment the day after a nighttime dose. The latest study demonstrating this — and prompting the current FDA warning about lower doses — was a controlled trial with 91 subjects. Half were administered eszopiclone and the other half a placebo. Those given eszopiclone were significantly more likely to experience impairment on memory- and driving-related tests, with meaningful impairment still present nearly 12 hours after taking the drug. Of further concern, affected subjects were not aware of their impairment, reporting similar rates of sedation and coordination as those who were not impaired.

Despite these new findings, the FDA still recommends increasing the dose, “if needed,” from 1 mg to 2 or even 3 mg, doses the agency acknowledges “are more likely to result in next-day impairment of driving and other activities that require full alertness.”[5] Unfortunately, many patients likely will end up taking these higher doses, since most studies that showed the drug to have even slight benefits used higher doses.[6] Stronger action should be taken to protect consumers from this dangerous drug.

What You Can Do

Because the FDA provided no data demonstrating that a 1 mg starting dose was safe enough — or effective — for all potential users, we still recommend that patients not use eszopiclone at any dose. We also recommend against using any other sleep medicines, including other Z-drugs, for similar safety reasons, and instead recommend nondrug alternatives.  If you are currently taking eszopiclone or any other sleep drug, see your doctor to discuss nondrug remedies for your sleep problems. Never stop taking any medicine before seeing your doctor.

References

[1] Food and Drug Administration. Safety Communication. FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose. May 15, 2014. http://www.fda.gov/Drugs/DrugSafety/ucm397260.htm. Accessed August 17, 2014.

[2] A Review of Eszopiclone (LUNESTA): A Not-So-New Sleeping Pill. Worst Pills, Best Pills News. July 2005. /newsletters/view/399. Accessed August 17, 2014.

[3] Ibid.

[4] Weich S, Pearce HL, Croft P, et al. Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: retrospective cohort study. BMJ. 2014;348:g1996.

[5] Ibid.

[6] Food and Drug Administration. Eszopiclone label. May 2014. (p. 18-19). http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf. Accessed August 17, 2014.