Safety

Clinical Trials Experience

Adverse Reactions Observed at an Incidence of ≥2% in Controlled Trials

Table 1 shows the incidence of adverse reactions from a Phase 3 placebo-controlled study of LUNESTA at doses of 2 or 3 mg in non-elderly adults. Treatment duration in this trial was 44 days. The table includes only reactions that occurred in 2% or more of patients treated with LUNESTA 2 mg or 3 mg in which the incidence in patients treated with LUNESTA was greater than the incidence in placebo-treated patients.

  Table 1: Incidence (%) of Adverse Reactions in a 6-Week Placebo-Controlled Study in Non-Elderly Adults with LUNESTA  
Adverse Reaction Placebo
(n=99)
LUNESTA 2 mg
(n=104)
LUNESTA 3 mg
(n=105)
Body as a Whole      
Headache 13 21 17
Viral Infection 1 3 3
Digestive System      
Dry Mouth 3 5 7
Dyspepsia 4 4 5
Nausea 4 5 4
Vomiting 1 3 0
Nervous System      
Anxiety 0 3 1
Confusion 0 0 3
Depression 0 4 1
Dizziness 4 5 7
Hallucinations 0 1 3
Libido Decreased 0 0 3
Nervousness 3 5 0
Somnolence 3 10 8
Respiratory System      
Infection 3 5 10
Skin and Appendages      
Rash 1 3 4
Special Senses      
Unpleasant Taste 3 17 34
Urogenital System      
Dysmenorrhea* 0 3 0
Gynecomastia** 0 3 0

Reactions for which the LUNESTA incidence was equal or less than placebo are not listed on the table, but included the following: abnormal dreams, accidental injury, back pain, diarrhea, flu syndrome, myalgia, pain, pharyngitis, and rhinitis.
* Gender-specific adverse reaction in females
** Gender-specific adverse reaction in males

Adverse reactions from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste.

Next Day Residual Effects1

In a double-blind study of 91 healthy adults age 25- to 40 years, the effects of LUNESTA 3 mg on psychomotor function were assessed between 7.5 and 11.5 hours the morning after dosing. Measures included tests of psychomotor coordination that are correlated with ability to maintain a motor vehicle in the driving lane, tests of working memory, and subjective perception of sedation and coordination. Compared with placebo, LUNESTA 3 mg was associated with next- morning psychomotor and memory impairment that was most severe at 7.5 hours, but still present and potentially clinically meaningful at 11.5 hours. Subjective perception of sedation and coordination from LUNESTA 3 mg was not consistently different from placebo, even though subjects were objectively impaired.


Reference:

1. LUNESTA [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May, 2014.

 

Important Safety Information & Indication

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

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. The risk of next-day psychomotor impairment is increased if LUNESTA is taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of eszopiclone.

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 or other sedative hypnotics.

Due to the concern of impaired motor, cognitive performance and increased sensitivity in elderly patients the dose should not exceed 2 mg in elderly or debilitated patients.

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 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.

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.