A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study

Inclusion Criteria:

1. Willing and able to provide informed consent prior to initiation of study procedures
2. Males and females, ages 18-65 years (inclusive)
3. Willing to use a highly effective method of contraception for the duration of the study (see Section 9.8.1) for more details on acceptable forms of contraceptives)
4. Can follow directions and comply with schedule of visits
5. Has a valid email address
6. Has access to a mobile device and Wi-Fi and is willing to download required applications on their own device
7. Has a computer with a keyboard for study questionnaires
8. Diagnosis of chronic insomnia based on DSM-5-TR criteria at least three nights per week and for at least 3 months
9. Modified Insomnia Severity Index (ISI) of 7 or higher
10. Willing to keep a regular sleep schedule and not deviate the sleep period by more than 90 minutes during study participation
11. Have not used a hypnotic prescription medication in the 4 weeks preceding study enrollment or a supplement or OTC sleep aid (e.g., melatonin) for 2 weeks before study enrollment

Exclusion Criteria:

1. Non-English-speaking participants
2. Participants currently participating in any other clinical trial for insomnia or requiring the use of experimental drugs
3. Untreated sleep apnea (defined as overall Apnea-Hypopnea Index [AHI] >15 within the preceding 12 months or a STOP-BANG score over 5 within 3 months of enrollment)
4. Current diagnosis or symptoms of restless legs syndrome or significant periodic limb movements (index over 15/h) in sleep
5. Suicide thoughts, behavior, and/or attempt in past 5 years
6. Underlying active diagnosis of circadian rhythm sleep-wake disorder (including current shift work) or underlying active diagnosis of parasomnia
7. At Screening, a score greater than 0 on the C-SSRS
8. Use of alcoholic drinks more frequently than one drink per day and more than 3 times a week
9. Use of coffee or caffeinated beverages within 6 hours of bedtime
10. Changes in use of nicotine or vaping within one month prior to randomization (use must be stable)
11. Use of cannabidiol (CBD)-containing or other cannabis-based products (e.g., tetrahydrocannabinol [THC]) within 2 weeks of study enrollment
12. Clinically unstable cardiac arrhythmia
13. Cardiovascular revascularization procedure within 3 months
14. History of an epileptic seizure in past 5 years
15. Diagnosis of dementia or neurodegenerative disease
16. Glaucoma
17. Participants undergoing peritoneal dialysis or hemodialysis
18. Active kidney or liver disease, including an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², Child-Pugh score ≥7, or clinical evidence of ascites or hepatic encephalopathy. The most recent eligible laboratory results must have been obtained within 30 days prior to enrollment, defined as the pre-randomization visit (e.g., Day -14 to -5).
19. Current diagnosis of active malignancy or oncological disease with poor prognosis based on clinical assessment
20. Current or planned chemotherapy treatment in the next 3 months
21. Pregnancy, within 4 months post-partum, actively nursing, or planning to conceive within 3 months of enrollment
22. Acute or chronic pain secondary to a rheumatic disease or another untreated chronic disease interfering with sleep
23. Mental or physical incapacities that interfere with activities of daily living (ADLs), impeding participation in interviews, or overnight sleep monitoring
24. Participants with any clinical signs or symptoms of active infection or inflammatory conditions including upper respiratory infection that may impact sleep
25. Active psychiatric disorder requiring medication therapy or one in which medication was recommended by a provider but declined by the participant (e.g., major depressive or bipolar disorder in active treatment with medication or where a physician has recommended medical therapy in past year)
26. Severe psychiatric disorder; or diagnosis of major depressive disorder in the clinical records in past 5 years
27. Alcohol or drug abuse during the last year (DSM-5-TR criteria)
28. Use of anticoagulant medication except for low-dose aspirin (e.g., 81 mg per day)
29. Current, regular use of a medication that could interfere with sleep (e.g. antidepressants, steroids/glucocorticoids, opioid pain killers, sedating antihistamine). Allowed pain medications include acetaminophen and ibuprofen.
30. Current use of an antidepressant or anti-psychotic medication, including monoamine oxidase inhibitors
31. Current use of strong CYP3A4 inhibitors or inducers (Appendix J)
32. Active medical problem which required hospitalization or emergency care in the past 6 months
33. Hospital admission or outpatient surgical procedure within 3 months of study enrollment
34. Any other condition that, in the Investigator's opinion, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results