| Document Date: 2014-04-14 13:38:58
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City Reference / / Company Jazz Pharmaceuticals / / Event Product Issues / / IndustryTerm machinery / opalescent oral solution / food / hazardous machinery / Healthcare providers / / MedicalCondition Parasomnias / CNS depression / headache / obstructive sleep apnea / thought disorders / panic attack / enuresis / hallucinations / coma / nausea / Muscle spasms / potential injury / tremor / syncope / and Drug Abuse / SYSTEM (CNS) DEPRESSION / sleepwalking / depressive illness / rare disorder / profound CNS depression / specific medical disorder / Parasomnias Sleepwalking / Diarrhea / hypersensitivity / Central Nervous System Depression / paranoia / hypotension / ataxia / Sleep-Disordered Breathing / Succinic semialdehyde dehydrogenase deficiency / mental retardation / hypertension / depressive psychiatric disorder / baseline apnea / true somnambulism / arthralgia / central apneas / Carcinogenesis / narcolepsy / Disorientation / apnea / seizure / vomiting / increased depression / significant injury / Sleep paralysis / severe sleep-disordered breathing / heart failure / drug abuse / Sleep walking / reported sleepwalking episodes / Respiratory depression / hypotonia / moderate-to-severe sleep apnea / dizziness / clinically significant respiratory depression / Depression / Cataplexy / Paresthesia / disorders / parasomnia occurring / / MedicalTreatment hormone replacement therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / Xyrem administration / / / Product Divalproex Sodium / XYREM / motor / occupations / activities / machinery / renal function / / Technology Pharmacokinetics / 3g / / URL www.fda.gov/Medwatch / www.XYREM.com / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XYREM safely and effectively. See full prescribing information for XYREM. XYREM® (sodium oxybate) oral solution, CI