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.