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DRUG APPROVAL
March 2005
TM
Lunesta (eszopiclone)
LunestaTM (eszopiclone, Sepracor Inc.), formerly known as Estorra, was approved in December 2004
by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia.1,2 Lunesta falls in a
class of medications known as sedative-hypnotics It is classified as a C-IV controlled substance; C-IV
controlled substances are defined as having low abuse potential and known medical uses.1 Lunesta
therapy is not limited to short-term use.1 Adverse events with Lunesta therapy may include headache, dry
mouth, nausea, dizziness, nervousness, a state of drowsiness/sleepiness, infection, unpleasant taste, or
issues with digestion (e.g. heartburn or nausea).1 Lunesta is available as 1 mg, 2 mg, and 3 mg tablets.1
BACKGROUND
As many as one-third of patients seen in the primary care setting may experience trouble sleeping from
time to time, and 10 percent of those may have chronic sleep problems.3 About 30 percent to 40
percent of adults report some level of insomnia within any given year, and about 10 percent to
15 percent report that the insomnia is chronic and/or severe.3 The occurrence of insomnia grows with
age and is more common in women.3 Insomnia is generally described as not enough sleep or poor
quality sleep.3 It is made up of one or more of the following: trouble falling asleep, trouble staying
asleep, waking up too early in the morning, or nonrefreshing sleep.3 Insomnia also involves daytime
symptoms, such as tiredness, lack of energy, trouble concentrating, or irritability.3
CAREMARK
RESPONSE
Based on currently available data, Caremark recommends for your consideration and at your discretion,
coverage of Lunesta when your prescription benefit plan also covers other sedative-hypnotic drugs for
the treatment of insomnia.
Clinical programs are available for Lunesta that focus on managing appropriate utilization. Please
contact your Caremark account representative for further details.
Caremark will continue to monitor the use of Lunesta to determine if any additional clinical programs
are needed.
CONTACT
For more information call your Caremark account representative.
Please Note: This document provides a brief overview of the subject. Please refer to the manufacturer’s
full prescribing information for a complete discussion of the product. This review is provided as a
reference only, and is based in part on information derived from third parties.
References
1. Lunesta™ product information. Sepracor Inc., December 2004.
2. Sepracor Inc. Press Release: Lunesta™ Brand Eszopiclone, Formerly, Estorra, Approved by FDA for Treatment of Insomnia.
Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=90106&p=irol-newsArticle_print&ID=655288&highlight=. Accessed on:
January 28, 2005.
3. National Institutes of Health National Heart Lung and Blood Institute. National Center on Sleep Disorders Research and Office of
Prevention, Education, and Control. Insomnia: Assessment and Management in Primary Care. Available at:
http://www.nhlbi.nih.gov/health/prof/sleep/insom_pc.pdf. Accessed on: January 31, 2005.
©2005 Caremark Inc. All rights reserved.
E-22-03-05