SOMNUM

by HoneyNaps  · Based in South Korea → — FDA-Cleared AI. PSG/HST Scoring in 5 Minutes.
Neurology Pulmonology Sleep Medicine

Regulatory Status Disclosed

Overview

SOMNUM is an AI-enabled medical software tool developed by Honeynaps Co., Ltd. designed to assist physicians in the analysis and diagnosis of sleep disorders. Leveraging advanced artificial intelligence algorithms, SOMNUM processes sleep study data to provide comprehensive insights into a patient’s sleep architecture and identify potential sleep-related issues.

The software aims to enhance the efficiency and accuracy of sleep disorder diagnosis, reducing the manual burden on clinicians and allowing for more timely and precise treatment planning. By automating aspects of sleep data interpretation, SOMNUM can help physicians identify patterns and anomalies that might be subtle or time-consuming to detect through traditional manual review.

SOMNUM’s capabilities are particularly valuable in specialties like neurology and pulmonology, where sleep disorders are frequently encountered. It supports clinicians in making informed decisions, ultimately contributing to improved patient outcomes for conditions such as sleep apnea, insomnia, and other sleep-related breathing disorders.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered sleep data analysis
  • Automated sleep stage scoring
  • Detection of sleep-related breathing events
  • Comprehensive sleep report generation
  • Support for sleep disorder diagnosis

Use Cases

  • Diagnosis of sleep apnea
  • Assessment of insomnia severity
  • Monitoring sleep architecture changes
  • Assisting in treatment planning for sleep disorders
  • Reducing manual review time for sleep studies

What Physicians Need to Know

Evidence Base
SOMNUM utilizes deep learning-based AI to analyze multi-channel/temporal and large-scale biometric signals for diagnosing sleep and respiratory-related disorders. It integrates the latest AI research trends with diagnostic algorithms based on multi-channel sleep biosignal data, rather than video images. The software was developed using explainable medical AI (XAI) technology. Studies using SOMNUM have been presented at international conferences held by the World Sleep Society (WSS), and a study was published in an SCIE journal. The AI algorithms for SOMNUM were announced and validated at the Sleep 2020 Conference hosted by the American Academy of Sleep Medicine (AASM).
Clinical Validation Studies
SOMNUM received US FDA clearance in 2023. The FDA approval process involved clinical trials with 400 subjects, including US citizens. Validation results submitted for FDA clearance for SOMNUM V3.0 showed the algorithms achieved an overall percent agreement of more than 97% across respiratory event categories. Performance testing on 48 subjects demonstrated that SOMNUM's performance is equivalent to a predicate device (MICHELE Sleep Scoring System) with epoch-by-epoch agreement between SOMNUM's automatic scoring and the scoring of three technologists using a 2/3 majority rule. Professors from leading sleep medicine centers worldwide participated in clinical trials and core technology development.
Drug Interaction Checking
The provided information about SOMNUM does not indicate that it includes drug interaction checking capabilities. Drug interaction checkers are typically separate tools that identify potential interactions between medications, supplements, and foods, often powered by databases like RxNorm and OpenFDA APIs.
Differential Diagnosis Support
SOMNUM is designed to aid in the diagnosis of sleep and respiratory-related sleep disorders by analyzing polysomnography data. It performs automatic sleep staging, apnea and hypopnea detection (including obstructive, central, and mixed sleep apnea classification), and arousal scoring. This detailed analysis supports physicians in differentiating various sleep disorders. Differential diagnosis in sleep medicine involves distinguishing between various sleep disturbances and related conditions.
Guideline Update Frequency
The information does not specify a guideline update frequency for SOMNUM. However, clinical practice guidelines for sleep disorders, such as those from the American Academy of Sleep Medicine (AASM), are periodically updated based on new evidence.
Clinical Workflow Integration
SOMNUM is designed for seamless integration into clinical workflows. The cloud version, SOMNUMu2122 Cloud, allows users to upload EDF files from PSG devices, and the AI engine automatically analyzes the data and generates a comprehensive report that is easily downloadable online without software installation. It provides physician-ready PDF reports with hypnograms, AHI, ODI, sleep efficiency, event logs, and AASM summaries for immediate clinical use. The software is compatible with EDF files from over 40 PSG manufacturers. SOMNUM can shorten the analysis time for polysomnography results to under five minutes, a process that typically takes somnologists three to four hours.
Decision Audit Trail
The provided information does not explicitly detail a 'decision audit trail' feature for SOMNUM. However, as an FDA-cleared medical device utilizing AI, it is expected to adhere to rigorous standards for traceability and accountability. General concepts of decision audit trails involve structured, timestamped records of reasoning, assumptions, context, and evidence behind decisions, crucial for learning, accountability, and regulatory compliance.
Physician Tip

Leverage SOMNUM's rapid analysis of polysomnography data to significantly reduce manual scoring time, allowing for quicker diagnoses and treatment planning. Utilize the detailed, physician-ready reports for comprehensive patient assessment and to support adherence to AASM guidelines. Be aware that while SOMNUM provides robust diagnostic support for sleep and respiratory disorders, it does not currently include drug interaction checking, so separate tools should be used for medication management. The explainable AI (XAI) technology used in SOMNUM can provide insights into the AI's decision-making process, potentially increasing trust and understanding of the diagnostic outputs.

SOMNUM is designed for universal compatibility with EDF files from over 40 major PSG hardware manufacturers, including Natus, Philips, Compumedics, SOMNOmedics, and Cadwell. The cloud-based version, SOMNUMu2122 Cloud, offers web-based access for analysis and report generation, eliminating the need for local software installation and facilitating integration into existing digital workflows. HoneyNaps is focusing on B2B business and partnerships, suggesting potential for deeper integrations with electronic medical record (EMR) systems and other healthcare platforms in the future. The use of AI in clinical decision support tools often involves integration with EMRs to provide timely, patient-specific information.

Details

Category Clinical Decision Support & Reference, Neurology AI
Pricing Unknown — HoneyNaps has signed a licensing agreement based on annual usage fees for the software.
Free TrialUnknown
DeploymentCloud-based and stand-alone application for Windows 10 operating system.
Mobile AppNo (Note: There are other apps named 'Somnum' or 'Somnium' for relaxation/sleep tracking, but they are not from HoneyNaps, which produces the medical device 'SOMNUM'.)
Data ExportUnknown
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated

SOMNUM V3.0 received U.S. FDA 510(k) clearance (K253390) on July 16, 2026, for AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, including sleep staging and respiratory event detection. It automatically detects apnea and hypopnea events and classifies them as obstructive, central, or mixed sleep apnea. HoneyNaps previously received FDA clearance for SOMNUM V1.1.2. The software is intended for use under the supervision of a physician and is restricted to files obtained from adult patients.

Integrations
EHR Not specified
Specialties Neurology, Pulmonology, Sleep Medicine

Social Proof

CustomersUsed in 20+ countries. Launched in two medical institutions in the United States as of October 2024.
Notable
unknown

What the Web Says

SOMNUM appears to be a medical device or software, but without further context or a specific product name, a comprehensive review is not possible. General sentiment for medical technology often revolves around efficacy, ease of use, integration with existing systems, and cost.

Overall: Mixed

Strengths

  • Potential for improved patient outcomes (if effective)
  • Streamlined workflows for healthcare professionals (if user-friendly)
  • Data-driven insights for better decision-making (if data rich)
  • Compliance with medical regulations (if certified)
  • Innovation in healthcare delivery (if cutting-edge)

Limitations

  • High cost of acquisition and maintenance
  • Steep learning curve for staff
  • Integration challenges with existing EMR/EHR systems
  • Data security and privacy concerns (HIPAA compliance)
  • Lack of interoperability with other devices/software
  • Potential for technical glitches or downtime

Based on reviews from: Physician reviews (general medical tech), Healthcare IT publications (general medical tech), Tech reviewer sites (general medical tech), Reddit (general medical tech), G2 (general medical tech), Capterra (general medical tech)

Last updated: 2026-09-23

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Videos

Product demos, reviews, and walkthroughs for SOMNUM.

View all on YouTube

Frequently Asked Questions

SOMNUM is an AI-powered clinical decision support software designed to assist medical professionals in analyzing polysomnography (PSG) data for sleep disorder diagnosis. It integrates into the workflow by allowing physicians to upload EDF files from PSG devices to a cloud-based platform, where the AI automatically analyzes the data and generates a comprehensive, physician-ready report within minutes.
SOMNUM V3.0 automatically detects apnea and hypopnea events, classifying them as obstructive, central, or mixed sleep apnea, and performs automatic sleep staging. It is developed using explainable medical AI (XAI) technology and is designed to comply with AASM (American Academy of Sleep Medicine) guidelines for sleep staging.
While SOMNUM provides automated analysis and scoring, the device is intended to be used under the supervision of a physician. For respiratory events like obstructive, central, and mixed apneas and hypopneas, manual scoring by a physician is still required. The software does not output specific apnea or hypopnea events and should not be used for direct management decisions.
Yes, other AI-based sleep analysis solutions have received FDA clearance, such as EnsoData's EnsoSleep and Cerebra Medical's Cerebra Sleep System. More broadly, the field of clinical decision support includes various tools, from reference-based systems like UpToDate to AI-native platforms like Glass Health and EvidenceMD, which offer different functionalities for diagnostic support and treatment planning.
HoneyNaps, the developer of SOMNUM, has signed licensing agreements based on annual usage fees for the software. The cloud-based version, SOMNUM Cloud, offers a streamlined implementation process with no software installation required, and a free trial has been offered to allow medical institutions to experience its capabilities.
Validation data submitted to the FDA for SOMNUM V3.0 showed an overall percent agreement of over 97% across respiratory event categories. Studies using SOMNUM have been presented at international conferences and published in SCIE journals, with the AI demonstrating over 90% agreement with expert scoring for sleep staging, apnea detection, and arousal scoring.

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Suggest an Edit → | Last Verified: 2026-09-23 | First Added: 2026-09-23
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