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MEDICAL INFORMATION REQUEST
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:
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 additional symptoms suggesting anaphylaxis, have been reported in patients after taking sedative-hypnotics, including LUNESTA. Patients who experience such reactions should not be rechallenged with the drug.
A variety of abnormal thinking and behavior changes, such as decreased inhibition, bizarre behavior, agitation and hallucinations have been reported to occur in association with the use of sedative/hypnotics. 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. Discontinuation of LUNESTA should be strongly considered who report a sleep driving episode.
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. Intentional overdose is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
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 carefully monitored.
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 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 taking the drug, including potential impairment of the performance of such activities that may occur the following day. Dose adjustment may be necessary when LUNESTA is co-administered with other CNS-depressants due to potential additive effects. LUNESTA should not be taken with alcohol.
In clinical trials, the most common adverse events associated with LUNESTA were unpleasant taste, headache, somnolence, dizziness, dry mouth, infection, and pain.
