LUNESTA® (eszopiclone) was effective in treating insomnia symptoms in multiple patient types to help provide a restful night’s sleep.*1-13
*In clinical studies, LUNESTA was proven effective to help the majority of insomnia patients to fall asleep and stay asleep for up to 7 hours. Individual results may vary.
†For the majority of LUNESTA studies, sleep latency was the primary endpoint. WASO and TST were typically key secondary or secondary endpoints. ISI was a secondary endpoint. P values of secondary endpoints are nominal and unadjusted for multiplicity.
‡Patients in this study received LUNESTA 3 mg plus fluoxetine or placebo plus fluoxetine.
§Patients in this study received LUNESTA 3 mg plus escitalopram or placebo plus escitalopram.
1. LUNESTA [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May, 2014.
2. Zammit GK, McNabb LJ, Caron J, Amato DA, Roth T. Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia. Curr Med Res Opin. 2004;20(12):1979-1991.
3. Data on file, CSR 190-046. Sunovion Pharmaceuticals Inc.
4. 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(7):793-799.
5. Walsh JK, Krystal AD, Amato DA, et al. Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. SLEEP. 2007;30(8):959-968.
6. Fava M, McCall WV, Krystal A, et al. Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biol Psychiatry. 2006;59(11):1052-1060.
7. Pollack M, Kinrys G, Krystal A, et al. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008;65(5):551-562.
8. Soares CN, Joffe H, Rubens R, et al. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial. Obstet Gynecol. 2006;108(6):1402-1410.
9. Ancoli-Israel S, Krystal AD, McCall WV, et al. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. SLEEP. 2010;33(2):225-234.
10. McCall WV, Erman M, Krystal AD, et al. A polysomnography study of eszopiclone in elderly patients with insomnia. Curr Med Res Opin. 2006;22(9):1633-1642.
11. Scharf M, Erman M, Krystal AD, et al. A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. SLEEP. 2005;28(6):720-727.
12. Data on file, NCT01710631. CSR 190-049. Sunovion Pharmaceuticals Inc.
13. Data on file, NCT00352144. CSR 190-050. Sunovion Pharmaceuticals Inc.
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.
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.