The inability to achieve sleep maintenance is the #1 sleep problem in the United States.¹²

A major treatment goal for most insomnia patients should be improved sleep maintenance (staying asleep).¹³

LUNESTA increases Total Sleep Time...

* A 6-month trial in adults with chronic insomnia (N=788) compared LUNESTA 3 mg to placebo, using patient-reported measures of efficacy and safety in a double-blind, parallel-group design.

• LUNESTA patients had an increase in TST of almost 1.3 hours per night vs. baseline, or the equivalent of an extra 9.1 hours of sleep per week.^2,5

All patients studied had primary chronic insomnia per DSM-IV.

A double-blind, parallel-group, 6-week trial in adults with chronic insomnia (N=308). Study compared LUNESTA 2 mg and 3 mg to placebo, with objective and patient-reported endpoints measured for 4 weeks and 6 weeks, respectively

LUNESTA is a non-benzodiazepine with an FDA-approved indication for sleep maintenance. No significant rebound insomnia has been observed at doses up to 3 mg, and there were no next-day residual effects in most patients.^1,9

§ Average of 3 next-morning time-points (Days 1, 15, and 29), taken from a double-blind, parallel-group study in adults with chronic insomnia.

• The improvement in Digit-Symbol Substitution Test (DSST) scores for the placebo group was significantly greater compared with LUNESTA 3 mg on Night 1, but was not statistically different from LUNESTA 3 mg on Nights 15 and 29¹.
• For the LUNESTA 2 mg group, DSST change scores were not significantly different from placebo at any time-point¹.

References:
1. Zammit GK, McNabb LJ, Caron J, et al. Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia. Curr Med Res Opin. 2004;20:1979-1991.

2. Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. SLEEP. 2003;26:793-799.

5. Data on file, Sepracor Inc.

9. LUNESTA prescribing information.

12. National Sleep Foundation. 2005 Sleep in America Poll. Summary of Findings. Available at: http://www.sleepfoundation.org/_content/hottopics/2005_summary_of_findings.pdf. Accessed August 23, 2005.

13. Thase ME. Correlates and consequences of chronic insomnia. Gen Hosp Psychiatry. 2005;27:100-112.

Lunesta is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.

IMPORTANT SAFETY INFORMATION:
LUNESTA, like other hypnotics, has CNS-depressant effects. Because of the rapid onset of action, LUNESTA should only be ingested immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep. Patients should not take LUNESTA unless they are prepared to get a full night’s sleep. As with other hypnotics, patients receiving LUNESTA should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination (e.g., operating machinery or driving a motor vehicle) after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of LUNESTA. In clinical trials, the most common adverse events associated with LUNESTA were unpleasant taste, headache, somnolence, dizziness, dry mouth, infection, and pain.

LUNESTA has been classified as a Schedule IV controlled substance. Sedative hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. Use of benzodiazepines and similar agents may lead to physical and psychological dependence. The risk of abuse and dependence increases with the dose and duration of treatment and concomitant use of other psychoactive drugs. The risk is also greater for patients who have a history of alcohol or drug abuse or history of psychiatric disorders. These patients should be under careful surveillance when receiving LUNESTA or any other hypnotic.

LUNESTA, like other hypnotics, may produce additive CNS-depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs that themselves produce CNS depression. LUNESTA should not be taken with alcohol. Dosage adjustment may be necessary when LUNESTA is administered with other CNS-depressant agents because of the potentially additive effects.

Sedative/hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression. Suicidal tendencies may be present in such patients, and protective measures may be required. Intentional overdose is more common in this group of patients. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported in association with the use of sedative/hypnotics; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. The recommended starting dose of LUNESTA for these patients is 1 mg.

Coadministration of eszopiclone 3 mg and olanzapine 10 mg produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug. Coadministration of eszopiclone 3 mg to subjects receiving ketoconazole 400 mg resulted in a 2.2-fold increase in exposure to eszopiclone, but no impact on drug levels of ketoconazole.

As with all sedative/hypnotic drugs, somnambulism (sleepwalking), including eating or driving while not fully awake, with amnesia for the event, has been reported. Additionally, rare cases of severe allergic reactions have been reported. Patients who report these events should discontinue treatment and should not be rechallenged with the drug.

The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Full Prescribing Information

LUNESTA^® is a registered trademark of Sepracor Inc.
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