A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia

Who can take part

• Willing and able to provide informed consent prior to initiation of study procedures
• Males and females, ages 18-65 years (inclusive)
• 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)
• Can follow directions and comply with schedule of visits
• Has a valid email address
• Has access to a mobile device and Wi-Fi and is willing to download required applications on their own device
• Has a computer with a keyboard for study questionnaires
• Diagnosis of chronic insomnia based on DSM-5-TR criteria at least three nights per week and for at least 3 months
• Modified Insomnia Severity Index (ISI) of 7 or higher
• Willing to keep a regular sleep schedule and not deviate the sleep period by more than 90 minutes during study participation
• 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

Who cannot take part

• Participants currently participating in any other clinical trial for insomnia or requiring the use of experimental drugs
• Changes in use of nicotine or vaping within one month prior to randomization (use must be stable)
• Current or planned chemotherapy treatment in the next 3 months
• 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)
• Alcohol or drug abuse during the last year (DSM-5-TR criteria)
• Use of anticoagulant medication except for low-dose aspirin (e.g., 81 mg per day)
• 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
• Current use of an antidepressant or anti-psychotic medication, including monoamine oxidase inhibitors
• Current use of strong CYP3A4 inhibitors or inducers (Appendix J)
• Hospital admission or outpatient surgical procedure within 3 months of study enrollment
• 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
• Current diagnosis or symptoms of restless legs syndrome or significant periodic limb movements (index over 15/h) in sleep
• Underlying active diagnosis of circadian rhythm sleep-wake disorder (including current shift work) or underlying active diagnosis of parasomnia
• Clinically unstable cardiac arrhythmia
• History of an epileptic seizure in past 5 years
• Diagnosis of dementia or neurodegenerative disease
• Current diagnosis of active malignancy or oncological disease with poor prognosis based on clinical assessment
• Acute or chronic pain secondary to a rheumatic disease or another untreated chronic disease interfering with sleep
• Participants with any clinical signs or symptoms of active infection or inflammatory conditions including upper respiratory infection that may impact sleep
• Severe psychiatric disorder; or diagnosis of major depressive disorder in the clinical records in past 5 years
• 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)
• Non-English-speaking participants
• 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)
• Suicide thoughts, behavior, and/or attempt in past 5 years
• At Screening, a score greater than 0 on the C-SSRS
• Use of alcoholic drinks more frequently than one drink per day and more than 3 times a week
• Use of coffee or caffeinated beverages within 6 hours of bedtime
• Use of cannabidiol (CBD)-containing or other cannabis-based products (e.g., tetrahydrocannabinol [THC]) within 2 weeks of study enrollment
• Cardiovascular revascularization procedure within 3 months
• Glaucoma
• Participants undergoing peritoneal dialysis or hemodialysis
• Pregnancy, within 4 months post-partum, actively nursing, or planning to conceive within 3 months of enrollment
• Mental or physical incapacities that interfere with activities of daily living (ADLs), impeding participation in interviews, or overnight sleep monitoring
• Active medical problem which required hospitalization or emergency care in the past 6 months