Sunovion Pharmaceuticals Receives Six Month U.S. Pediatric Exclusivity for LUNESTA® (eszopiclone)

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that it has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for LUNESTA (eszopiclone), a prescription sleep medicine used in adults for the treatment of insomnia. Sunovion has now gained an additional six months of United States market exclusivity for LUNESTA, which will expire on May 31, 2014.

The approval of pediatric exclusivity does not mean that LUNESTA is approved for use in pediatric patients. LUNESTA is FDA approved only for use in adults with insomnia aged 18 and older. Based on study results, Sunovion will not be seeking a pediatric indication for LUNESTA.

About Lunesta

Indication for LUNESTA

Lunesta (eszopiclone) is a prescription sleep medicine used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night.

IMPORTANT SAFETY INFORMATION FOR LUNESTA

LUNESTA acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Until you know how you will react to LUNESTA, you should not drive or operate machinery. Call your healthcare professional if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. Walking, eating, driving, or engaging in other activities while asleep without remembering it the next day have been reported. Other abnormal behaviors include aggressiveness, agitation, hallucinations, and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your healthcare professional if you experience these or any effects or reactions that concern you. LUNESTA, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness, and dizziness. For more information, please see the LUNESTA Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. The products discussed herein may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient. Remember that no medicine is for everyone. Only your healthcare professional can prescribe LUNESTA for you.

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Sunovion Pharmaceuticals Receives Six Month U.S. Pediatric Exclusivity for LUNESTA® (eszopiclone)