Chronic InsomniaPhase 2NCT07920185
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
A Phase 2 study testing Low Dose Drug A, Low Dose Drug B and High Dose Drug A in people with Chronic Insomnia, run by Somnum Pharma Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if SOM001 is safe and well tolerated in adults with insomnia. It will also evaluate if it helps to improve sleep. The main questions this trial aims to answer are: 1. Is SOM001 associated with any side-effects 2. Do people tolerate SOM001 well 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Low Dose Drug A, Low Dose Drug B and High Dose Drug A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- Non-English-speaking participants
- Participants currently participating in any other clinical trial for insomnia or requiring the use of experimental drugs
- 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)
- Current diagnosis or symptoms of restless legs syndrome or significant periodic limb movements (index over 15/h) in sleep
- Suicide thoughts, behavior, and/or attempt in past 5 years
- Underlying active diagnosis of circadian rhythm sleep-wake disorder (including current shift work) or underlying active diagnosis of parasomnia
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- 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
- Changes in use of nicotine or vaping within one month prior to randomization (use must be stable)
- Use of cannabidiol (CBD)-containing or other cannabis-based products (e.g., tetrahydrocannabinol [THC]) within 2 weeks of study enrollment
- Clinically unstable cardiac arrhythmia
- Cardiovascular revascularization procedure within 3 months
- History of an epileptic seizure in past 5 years
- Diagnosis of dementia or neurodegenerative disease
- Glaucoma
- Participants undergoing peritoneal dialysis or hemodialysis
- 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).
- Current diagnosis of active malignancy or oncological disease with poor prognosis based on clinical assessment
- Current or planned chemotherapy treatment in the next 3 months
- Pregnancy, within 4 months post-partum, actively nursing, or planning to conceive within 3 months of enrollment
- Acute or chronic pain secondary to a rheumatic disease or another untreated chronic disease interfering with sleep
- Mental or physical incapacities that interfere with activities of daily living (ADLs), impeding participation in interviews, or overnight sleep monitoring
- Participants with any clinical signs or symptoms of active infection or inflammatory conditions including upper respiratory infection that may impact sleep
- 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)
- Severe psychiatric disorder; or diagnosis of major depressive disorder in the clinical records in past 5 years
- 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)
- Active medical problem which required hospitalization or emergency care in the past 6 months
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
4 East 70th Street, 9a
New York, New York, 10021
Patricia Tolete, 347-49504416, patricia.tolete@phifundvc.com
About this study
Official title: A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, and Efficacy of Oral SOM001 in Adults With Chronic Insomnia
The goal of this clinical trial is to learn if SOM001 is safe and well tolerated in adults with insomnia. It will also evaluate if it helps to improve sleep. The main questions this trial aims to answer are:
- Is SOM001 associated with any side-effects
- Do people tolerate SOM001 well
- Is SOM001 helpful to improve sleep
Read more
Researchers will compare SOM001 to a placebo (a look-alike substance that contains no drug) as well as to 2 other well-established medications that are often used to treat sleep.
Participants will:
- Take one of the drugs, or placebo for 3 nights each week, for 3 weeks. The drugs will be pre-assigned and change each week.
- Be asked questions about their sleep and overall health, including mental health
- Complete tests to evaluate their memory and alertness on the computer
- Use monitors at night to evaluate their sleep quality and activity.
This will be a virtual study and participants will connect with the study team via video and phone calls for training and check-ups during the study.
Read the detailed description
This clinical trial aims to evaluate if SOM001 is safe and well tolerated, and if it helps to improve sleep in adults with insomnia. Up to 45 adults (ages 18 to 65) will be asked to participate in the study.
The study will be conducted in the participants' home environment and all visits will be remote using phone and video calls.
The study will include 3 main phases:
- Screening period to evaluate eligibility in the trial. It may include up to 4 visits and testing of sleep monitoring devices at home. If a person is not eligible, this will end their participation in the study. There will be no reimbursement for their time during this screening phase. A person will be deemed eligible if they meet the specific inclusion and exclusion criteria for the study and are willing to be monitored at home for the duration of the study. Eligible participants will be enrolled in the study.
- Study Intervention period: enrolled participants will be assigned to take the study medications before going to sleep for 3 nights a week, for 3 weeks. The study medications will consist of either SOM001, a placebo, or 2 other medications commonly used to treat insomnia. A different study medication will be given each week. On the nights that they take the study medications, participants will be asked to use monitors to evaluate their activity and sleep. These monitors will require them to use a phone application on their own mobile phones. Information and training on the use of these devices will be given by the research team. In the mornings after waking up, participants will remove the monitors and be asked to complete an online survey regarding their sleep and potential changes in symptoms. They will be also asked to complete an online test of memory and alertness. These morning assessments are expected to take up to 10 minutes to complete. Information from the questionnaires and the sleep monitoring devices used at night will be collected by the research team and used as part of the study. Each week the participants will have virtual visits. The sleep monitoring equipment will be provided to the participants free of charge and must be returned to the research team at the end of this phase.
- End of Study period will consist of a final virtual meeting with the research team to review their participation and issue their reimbursement for participating in the study.
- Conditions
- Chronic Insomnia
- Being tested
- Low Dose Drug A, Low Dose Drug B, High Dose Drug A, High Dose Drug B, SOM001-A
- Keywords
- insomnia, chronic insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Drug ADrug
Low Dose Drug A
Low Dose Drug BDrug
Low Dose Drug B
High Dose Drug ADrug
High Dose Drug A
High Dose Drug BDrug
High Dose Drug B
SOM001-ADrug
SOM001-A
SOM001-BDrug
SOM001-B
SOM001-CDrug
SOM001-C
SOM001-DDrug
SOM001-D
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SOM001-A and SOM001-B | Experimental | Not described Receives: Drug: SOM001-A; Drug: SOM001-B |
| Drug A | Active comparator | Not described Receives: Drug: Low Dose Drug A; Drug: High Dose Drug A |
| Drug B | Active comparator | Not described Receives: Drug: Low Dose Drug B; Drug: High Dose Drug B |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SOM001-C and SOM001-D | Experimental | Not described Receives: Drug: SOM001-C; Drug: SOM001-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events at 3 weeks after SOM001 intervention as compared to placebo
Measured: 3 weeks
Incidence, severity, and relationship of adverse events (AEs) after SOM001 intervention as compared to placebo
Measured: 3 weeks
Incidence of serious adverse events (SAEs) after SOM001 intervention as compared to placebo
Measured: 3 weeks
Secondary outcomes (3)
Changes in Wake After Sleep Onset (WASO) after SOM001 intervention as compared to placebo
Measured: 3 weeks
Changes in Latency to Persistent Sleep (LPS) after SOM001 intervention as compared to placebo
Measured: 3 weeks
Changes in Total Sleep Time (TST) after SOM001 intervention as compared to placebo
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somnum Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920185
- Sponsor's protocol ID
- SOM001-1
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, and Efficacy of Oral SOM001 in Adults With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT07920185
- Acronym / sponsor ID
- SOM001-1
- Conditions
- Chronic Insomnia
- Keywords
- insomnia, chronic insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Somnum Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if SOM001 is safe and well tolerated in adults with insomnia. It will also evaluate if it helps to improve sleep. The main questions this trial aims to answer are:
- Is SOM001 associated with any side-effects
- Do people tolerate SOM001 well
- Is SOM001 helpful to improve sleep
Researchers will compare SOM001 to a placebo (a look-alike substance that contains no drug) as well as to 2 other well-established medications that are often used to treat sleep.
Participants will:
- Take one of the drugs, or placebo for 3 nights each week, for 3 weeks. The drugs will be pre-assigned and change each week.
- Be asked questions about their sleep and overall health, including mental health
- Complete tests to evaluate their memory and alertness on the computer
- Use monitors at night to evaluate their sleep quality and activity.
This will be a virtual study and participants will connect with the study team via video and phone calls for training and check-ups during the study.
Detailed description
This clinical trial aims to evaluate if SOM001 is safe and well tolerated, and if it helps to improve sleep in adults with insomnia. Up to 45 adults (ages 18 to 65) will be asked to participate in the study.
The study will be conducted in the participants' home environment and all visits will be remote using phone and video calls.
The study will include 3 main phases:
- Screening period to evaluate eligibility in the trial. It may include up to 4 visits and testing of sleep monitoring devices at home. If a person is not eligible, this will end their participation in the study. There will be no reimbursement for their time during this screening phase. A person will be deemed eligible if they meet the specific inclusion and exclusion criteria for the study and are willing to be monitored at home for the duration of the study. Eligible participants will be enrolled in the study.
- Study Intervention period: enrolled participants will be assigned to take the study medications before going to sleep for 3 nights a week, for 3 weeks. The study medications will consist of either SOM001, a placebo, or 2 other medications commonly used to treat insomnia. A different study medication will be given each week. On the nights that they take the study medications, participants will be asked to use monitors to evaluate their activity and sleep. These monitors will require them to use a phone application on their own mobile phones. Information and training on the use of these devices will be given by the research team. In the mornings after waking up, participants will remove the monitors and be asked to complete an online survey regarding their sleep and potential changes in symptoms. They will be also asked to complete an online test of memory and alertness. These morning assessments are expected to take up to 10 minutes to complete. Information from the questionnaires and the sleep monitoring devices used at night will be collected by the research team and used as part of the study. Each week the participants will have virtual visits. The sleep monitoring equipment will be provided to the participants free of charge and must be returned to the research team at the end of this phase.
- End of Study period will consist of a final virtual meeting with the research team to review their participation and issue their reimbursement for participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SOM001-A and SOM001-B | Experimental | Drug: SOM001-A, Drug: SOM001-B |
| Drug A | Active comparator | Drug: Low Dose Drug A, Drug: High Dose Drug A |
| Drug B | Active comparator | Drug: Low Dose Drug B, Drug: High Dose Drug B |
| Placebo | Placebo comparator | Drug: Placebo |
| SOM001-C and SOM001-D | Experimental | Drug: SOM001-C, Drug: SOM001-D |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (34 listed)
- Non-English-speaking participants
- Participants currently participating in any other clinical trial for insomnia or requiring the use of experimental drugs
- 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)
- Current diagnosis or symptoms of restless legs syndrome or significant periodic limb movements (index over 15/h) in sleep
- Suicide thoughts, behavior, and/or attempt in past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Drug ALow Dose Drug A | Drug | Drug A |
| Low Dose Drug BLow Dose Drug B | Drug | Drug B |
| High Dose Drug AHigh Dose Drug A | Drug | Drug A |
| High Dose Drug BHigh Dose Drug B | Drug | Drug B |
| SOM001-ASOM001-A | Drug | SOM001-A and SOM001-B |
| SOM001-BSOM001-B | Drug | SOM001-A and SOM001-B |
| SOM001-CSOM001-C | Drug | SOM001-C and SOM001-D |
| SOM001-DSOM001-D | Drug | SOM001-C and SOM001-D |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events at 3 weeks after SOM001 intervention as compared to placebo
Time frame: 3 weeks
Incidence, severity, and relationship of adverse events (AEs) after SOM001 intervention as compared to placebo
Time frame: 3 weeks
Incidence of serious adverse events (SAEs) after SOM001 intervention as compared to placebo
Time frame: 3 weeks
3 secondary outcomes
Changes in Wake After Sleep Onset (WASO) after SOM001 intervention as compared to placebo
Time frame: 3 weeks
Changes in Latency to Persistent Sleep (LPS) after SOM001 intervention as compared to placebo
Time frame: 3 weeks
Changes in Total Sleep Time (TST) after SOM001 intervention as compared to placebo
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose Drug A, Low Dose Drug B and High Dose Drug A in people with Chronic Insomnia, run by Somnum Pharma Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Tolete (347-495-4416, patricia.tolete@phifundvc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events at 3 weeks after SOM001 intervention as compared to placebo (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.