SM-1 vs. an Active Comparator in A Model of Transient Insomnia

Exclusion Criteria

• •1. Clinically significant, acute illness within 14 days prior to screening
• •2. Clinically significant, unstable medical illness;
• •3. Evidence or history of clinically significant allergic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
• •4. History of cancer or diabetes;
• •5. A sitting blood pressure \> 140/90 millimeters mercury (mm/Hg) at screening;
• •6. Heart rate \> 100 beats per minute (BPM) at screening;
• •7. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition;
• •8. Subject has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the C-SSRS
• •9. History or presence of chronic pain;
• •10. Lifetime history of seizure disorder or serious head injury;
• •11. Clinically significant sleep disorder, including chronic insomnia, sleep apnea, narcolepsy, parasomnia, restless leg syndrome or circadian rhythm disorder;
• •12. Slept in a sleep laboratory at any time prior to Screening.
• •13. STOP-BANG sleep apnea questionnaire \>/= to 3 at Screening;
• •14. Epworth Sleepiness Scale (ESS) score \>10 at screening;
• •15. Any condition that may affect drug absorption;
• •16. Travel across more than three time zones or shift worker
• •17. Any clinically significant abnormal finding on physical examination, vital signs or clinical laboratory tests,
• •18. History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to diphenhydramine, zolpidem or lorazepam;
• •19. Pregnant or lactating females;
• •20. Positive serum or urine pregnancy test
• •21. Positive urine drug screen
• •22. Recent history or current evidence of alcohol or drug abuse
• •23. Regular consumption of "large amounts" of xanthine-containing substances (i.e., \[equivalent to approximately 2 - 3 cups of regular coffee\] or equivalent amounts of xanthine-containing substances);
• •24. Usual consumption of more than 14 units of alcohol per week.
• •25. Use of more than 10 cigarettes or equivalent per day of any product containing nicotine or routinely smokes during sleep period.
• •26. Stopped smoking or in a smoking cessation program within 90 days of screening;
• •27. Use of restricted concomitant medications, any prescription drug, OTC medication, grapefruit, grapefruit juice, herbal preparation or food supplement, excluding vitamins, acetaminophen or hormonal contraceptives
• •29\. Exposure to any investigational drug or to diphenhydramine, zolpidem or lorazepam or other drugs of the same pharmaceutical classes within 30 days of screening 30. Positive alcohol or drug test