54 396 Pill — WHITE ROUND, 9mm — Eszopiclone

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Imprint54 / 396
ColourWHITE
ShapeROUND
Size9
StrengthESZOPICLONE 3 mg
Dosage formTablet
ManufacturerLake Erie Medical DBA Quality Care Products LLC
NDC55700-172
ScheduleCIV
Availability—
IngredientsESZOPICLONE[ESZOPICLONE]

What does this imprint mean?

The imprint "54 396" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Eszopiclone

Uses and warnings

BOXED WARNING: "Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death." The label further warns of CNS depression (worse with alcohol or other depressants), next-day psychomotor/driving impairment, abnormal thinking and behavioral changes including hallucinations, and the need to prescribe the "smallest quantity feasible" for patients with depression given suicide risk.

"LUNESTA is indicated for the treatment of insomnia," decreasing sleep latency and improving sleep maintenance, as shown in controlled outpatient and sleep laboratory studies.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 2d9cc861-8e09-4001-b3b0-fd1462e775bd.xml