Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

Inclusion Criteria: * Adult 21 to 64 years of age; * 15≤AHI ≤ 50 on screening polysomnogram (PSG) * ESS score ≥ 7 * Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format; * Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner). Exclusion Criteria: * Arterial oxygen saturation \< 75% for \> 5% of sleep period time on screening PSG; * Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman); * Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8); * Body mass index \> 45 kg/m2 * Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment; * History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8); * Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age); * Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8); * Major surgery within 6 months prior to the first dose of study drug (Day 8); * Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8). * Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8); * Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis; * Any clinically significant unstable or progressive medical condition; * Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period); * Clinically significant or uncontrolled: chronic obstructive pulmonary disease (COPD), cardiovascular disease, gastrointestinal, respiratory, pancreatic, hepatic, renal, hematologic, endocrine \[including insulin-dependent diabetes mellitus (IDDM)\], neurological, urogenital, connective tissue, dermatological, thyroid, or other medical disorder; * Any clinically significant psychiatric disorder; * History of seizure disorder; * Treatment with any prescription antidepressant medication within 1 month prior to the first dose of study drug (Day 8); * Treatment with sedatives, hypnotics or other psychoactive drugs within 30 days prior to the first dose of study drug (Day 8); * Any complete blood count (CBC) or liver function test (LFT) laboratory value outside the normal range which, in the clinical judgment of the Investigator renders a subject inappropriate for randomization to treatment; * Pregnancy \[as demonstrated by positive urine human chorionic gonadotropin (hCG) test\] or lactation; * Allergic to cannabinoids or sesame oil; * History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel; * Use of dietary supplements which in the judgment of the Investigator may impact sleep or breathing behaviors; * Average daily caffeine consumption \> 500 mg/day (\~5 cups of coffee); * Average weekly alcohol consumption \> 10 units; * Unwillingness to abstain from caffeine and alcohol on all days when overnight or daytime testing will be performed; * Participation in any other investigational protocol within the 30 days prior to the first dose of study drug (Day 8); * Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.