Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation

Exclusion Criteria

• •Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder or narcolepsy.
• •An apnea-hypopnea index (AHI) score of \>10 or a periodic limb movement arousal index (PLMAI) score of \> 15 recorded during the screening period PSG.
• •Documented history of insomnia prior to onset of the alcohol use disorder (AUD), which did not worsen during the AUD period or during or after alcohol cessation.
• •Comorbid conditions which interfere with normal sleep pattern or the evaluation of next day residual effects.
• •Any lifetime history of suicidal ideation or behavior.
• •History of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion (including any surgical interventions for weight loss).
• •Any history of seizures (except related to alcohol withdrawal) or head trauma with sequelae.
• •Known history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV).
• •History of diagnosed, active liver disease or elevated liver enzymes/bilirubin.
• •History of kidney stones or renal insufficiency or abnormal kidney function at screening.
• •Uncontrolled hypertension (\> 140 mm Hg systolic / 90 mm Hg diastolic).
• •Use of any medication that affects sleep and/or wake function during the week before starting the screening period.
• •Subjects currently undergoing treatment of other addictions in addition to alcohol.
• •Excessive caffeine consumption.
• •Positive urine drug screen for prohibited substances, except for cannabis on a case-by-case basis.
• •History of drug use disorder over the past year, other than alcohol/nicotine/caffeine/cannabis.
• •Plans to travel across more than 3 time zones in the 2 weeks before screening, or during study participation.
• •Night or rotating shift worker.
• •Any history and/or current evidence of other medical (eg, cardiac, respiratory, gastrointestinal, renal, malignancy other than basal cell carcinoma), neurological, or psychiatric conditions that, in the opinion of the investigator, could affect the subject's safety or interfere with the study.