• LUNESTA should be taken immediately before bedtime
• The starting dose of LUNESTA should be 1 mg in patients with severe hepatic impairment; LUNESTA should be used with caution in hepatic-impaired patients
• The starting dose should not exceed 1 mg in patients taking LUNESTA along with any of the 7 potent CYP3A4 inhibitors; if needed, the dose can be raised to 2 mg. The 7 potent CYP3A4 inhibitors are:
• Ketoconazole (Nizoral®)
• Itraconazole (Sporanox®)
• Clarithromycin (Biaxin®)
• Nefazodone (Serzone®)
• Troleandomycin (Tao®)
• Ritonavir (Norvir®, Kaletra®)
• Nelfinavir (Viracept®)
• No clinically relevant drug-drug interactions with paroxetine, lorazepam, warfarin, or digoxin
• In clinical trials, some patients have reported an “unpleasant taste” after waking; patients may resolve the taste by brushing their teeth, drinking juice, or having breakfast

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).

The recommended starting dose for 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).

Nizoral is a registered trademark of McNeil-PPC, Inc.
Sporanox is a trademark of Janssen Pharmaceutica Products, L.P.
Biaxin, Norvir, and Kaletra are registered trademarks of Abbott Laboratories.
Serzone is a registered trademark of Bristol-Myers Squibb Company.
Tao is a registered trademark of Pfizer Inc.
Viracept is a registered trademark of Agouron Pharmaceuticals, Inc.

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.
©2008 Sepracor Inc. All rights reserved.