DO NOT USE ESZOPICLONE (LUNESTA) AT ANY DOSE

May 19, 2014

On May 15, 2014, the Food and Drug Administration (FDA) warned that the sleep drug eszopiclone (LUNESTA) can lead to potentially dangerous mental and physical impairment for more than 11 hours following a 3 mg dose.[1] The FDA recommends lowering the starting dose from 2 mg to 1 mg, but that is a dangerously misguided solution.

For one, the FDA still recommends increasing the dose to 2 or even 3 mg “if needed,” doses the agency acknowledges “are more likely to impair next-day driving and other activities that require full alertness.”[2] This is important because most patients will likely end up on these doses, since most of the studies that showed the drug to have even slight benefits used higher doses.[3]

Furthermore, eszopiclone’s risks, like those of most other pharmaceutical sleep aids, likely remain too high at any currently available dose to justify taking the medication. The FDA approved eszopiclone for insomnia in 2004 over the objections of its own scientists, who warned that animal studies suggested that eszopiclone could cause cancer in humans.[4] At the time, we warned Worst Pills, Best Pills News subscribers of these dangers and classified eszopiclone as a Do Not Use drug.[5]

Possible increased risk of death

Like other members of the “Z-drug” class of sleep medicines, eszopiclone causes dangerous mental and physical impairment the day after a nighttime dose. 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 drugs, after accounting for differences between the groups.[6]

The latest study, which prompted the current FDA warning about lower doses, was a controlled trial in 91 subjects, half of whom were administered eszopiclone and the other half placebo. Those given eszopiclone were significantly more likely to experience impairment on memory and driving-related tests, with meaningful impairment still present 11.5 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.

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 Z-drugs, for similar safety reasons and instead recommend nondrug alternatives. See worstpills.org for more information.

If you are currently taking eszopiclone or any other sleep drug, see your doctor to consider nondrug remedies for your sleep problems. Never stop any medicine before seeing your doctor.

To read the FDA’s announcement, visit: www.fda.gov/Drugs/DrugSafety/ucm397260.htm.

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 May 16, 2014.

[2] Ibid.

[3] Food and Drug Administration. Eszopiclone label. May 2014. (p. 18-19). http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf. Accessed May 16, 2014.

[4] A Review of Eszopiclone (LUNESTA): A Not-So-New Sleeping Pill. Worst Pills, Best Pills News. July 2005. https://www.worstpills.org/member/newsletter.cfm?n_id=399. Accessed May 16, 2014.

[5] Ibid.

[6] 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.