FDA Requiring Lower Starting Dose for Sleep Drug Lunesta

The FDA is requiring Sunovion, the manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug’s label and lower the current recommended starting dose.

The agency said that data shows that eszopiclone levels in some users may be high enough the next morning to impair activities that require alertness, including driving, even though they might feel wide awake.

The FDA has decreased the recommended starting dose from 2 mg to 1 mg for both men and women. The 1 mg dose can be increased to 2 mg or 3 mg as needed, but the higher doses are more likely to result in impairment the next morning. When using a lower dose, fewer amounts of the drug will remain in the body.

Patients currently taking the 2 mg and 3 mg doses should contact their doctor and discuss how they can take their medicine safely at an amount that’s best for them, the agency said.

The change is based on findings from a study of 91 healthy adults ages 25 to 40. Compared with a placebo, Lunesta 3 mg was associated with severe next-morning motor skill and memory impairment in both men and women, 7.5 hours after taking the drug.

Recommended doses can cause impairment to driving skills, memory and coordination up to 11 hours after the drug is taken, the study found. And despite these long-lasting effects, users were often unaware they were impaired. — Kellen Owings

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