Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

Exclusion Criteria

• •Subject has protocol prohibited medical \& psychiatric conditions that would exclude subject
• •Subject has a current or past history of a substance use disorder including alcohol abuse
• •Subject has a clinically significant history of seizure disorder either past or present
• •Female subject who is pregnant, nursing or lactating.
• •Subject is diagnosed with sleep apnea
• •Subject is unable to discontinue protocol prohibited medications
• •Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
• •Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
• •Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
• •Subject is on a sodium-restricted diet.
• •Subject has abnormal liver function test or other abnormal lab values
• •Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
• •Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
• •Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.