The dose of LUNESTA should be individualized. The recommended starting dose for LUNESTA for most non-elderly adults is 2 mg immediately before bedtime. Dosing can be initiated at or raised to 3 mg if clinically indicated, since 3 mg is more effective for sleep maintenance (see PRECAUTIONS in Full Prescribing Information).

The recommended starting dose of LUNESTA for elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime (see PRECAUTIONS in Full Prescribing Information).

Taking LUNESTA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of LUNESTA on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY in Full Prescribing Information).

Special Populations

Hepatic

The starting dose of LUNESTA should be 1 mg in patients with severe hepatic impairment. LUNESTA should be used with caution in these patients.

Coadministration With CYP3A4 Inhibitors

The starting dose of LUNESTA should not exceed 1 mg in patients coadministered LUNESTA with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg.

Indication and Important Safety Information for LUNESTA^® (eszopiclone)

Indication

LUNESTA^® (eszopiclone) 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 is contraindicated in patients with a known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema.

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.

Rare cases of angioedema and symptoms suggesting anaphylaxis have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including LUNESTA. Patients who experience such reactions should not be rechallenged with the drug.

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. These changes include decreased inhibition, bizarre behavior, agitation, hallucinations and confusion. Complex behaviors such as "sleep driving," preparing and eating food, making phone calls, or having sex while not fully awake, with amnesia for the event, have been reported. The use of alcohol and other CNS depressants appears to increase the risk of such behaviors. The emergence of any new behavioral sign or symptom requires immediate evaluation. LUNESTA should not be taken together with alcohol.

Due to the concern of impaired motor, cognitive performance and increased sensitivity in elderly patients, use a lower dose.

Sedative/hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression. 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.

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. LUNESTA is a Schedule IV controlled substance. Patients with a history of alcohol or drug abuse or history of psychiatric disorders should be under careful surveillance when receiving LUNESTA or any other hypnotic.

LUNESTA, like other hypnotics, has CNS-depressant effects. Because of the rapid onset of action, LUNESTA should only be taken immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination after taking LUNESTA, including potential impairment of the performance of such activities that may occur the day following ingestion of LUNESTA.

LUNESTA should be used with caution in patients with hepatic impairment, impaired respiratory function, impaired drug metabolism or hemodynamic responses.

In clinical trials, the most commonly observed adverse reactions (incidence ≥2%) were unpleasant taste, headache, somnolence, infection, dizziness, dry mouth, rash, anxiety, and hallucinations.

For additional information, please see the LUNESTA full Prescribing Information.