01 · Sleep diary
Record last night’s sleep each morning
Record bedtimes, wake times and sleep quality to understand your sleep pattern.
Insomnia · Prescription digital therapeutic
SleepQ®
Prescription software for insomnia treatment
Sleep records guide a personalized sleep schedule and six weeks of cognitive behavioral therapy.
Korea’s first integrated reviewInsurance listingCE marked
MFDS authorization 23-511 · Used with a prescription
SleepQ® · Europe
SleepQ®, from Korea to Europe
With European CE marking and a clinical study with Charité Berlin, SleepQ® is preparing to enter the German market.
- European CE marking
- EU Medical Device Regulation (MDR) · 2025
- Clinical study with Charité Berlin
- WELT-REST · Patient follow-up complete; results analysis underway
- Preparing for German statutory coverage
- Preparing for listing as a digital health application (DiGA)
How SleepQ® works
How SleepQ® supports treatment
Daily sleep records guide your sleep schedule and treatment program.
02 · Personalized sleep schedule
A sleep schedule based on your records
From week 2, recommended sleep times are guided by your records and updated weekly.
03 · Daily treatment program
Work on habits and thoughts that affect sleep
Learn through Sleep Exploration, find answers in Sleep Talk and practice relaxation exercises.
Screens from the user guide; the software may differ by software version.
Six-week treatment
A program guided by your sleep records
- Week 1
Start your sleep diary
Complete the initial questionnaire and record your sleep each day.
- Weeks 2–6
Personalized goals and treatment
Your recommended sleep schedule is updated weekly as you follow the treatment program.
- After six weeks
Review your progress
Review your outcomes with your clinician using the final questionnaire and sleep records.
SleepQ® · Clinical evidence
Greater improvement in sleep efficiency
- Participants
- Adults with insomnia
- Comparator
- Sham software
- Assessment
- Six weeks of treatment; week-seven assessment
Improvement in sleep efficiency from baseline
Sleep efficiency is the proportion of time in bed spent asleep. Bars show adjusted changes from baseline in percentage points (pp).
Between-group difference+8.28pp
SleepQ® improved sleep efficiency by 8.28 percentage points more than the sham software control.
A percentage point (pp) is the unit used for the difference between two percentages.
p = 0.0418Study design and interpretation
- Design
- Double-blind, sham-controlled randomized trial / Severance Hospital
- Population
- 68 randomized; efficacy analysis of 54 (SleepQ® 28, control 26)
- Assessment
- After six weeks of treatment; seven weeks including assessment
- Statistics
- Difference 8.28 percentage points; 95% CI 0.32–16.24; effect size d = 0.68
- Safety
- Eight mild adverse events were reported. No device-related or serious adverse events were reported.
RWE · Routine clinical care
Improvement in insomnia symptoms
in routine clinical care
An RWE analysis of patients prescribed SleepQ® estimated an average 6.59-point reduction in the Insomnia Severity Index (ISI) from before to after treatment.
37
Participating hospitals
−6.59 points
Average ISI change from before treatment
What this measure means
The ISI is a questionnaire that measures insomnia symptom severity. Lower scores indicate less severe symptoms, so a lower average score reflects improvement.
SleepQ® milestones
SleepQ®: Korea’s first integrated innovative-device review
MFDS authorization
23-511 · Innovative device No. 25
First integrated review
A pathway from authorization to clinical use
Prescribing and evaluation fees
TU001 prescribing · TU002 evaluation · TX010 use fee (non-covered)
Nationwide prescribing
Full-scale commercial rollout to hospitals
The SleepQ® usage fee is a recognized non-covered item, distinct from National Health Insurance benefit coverage. Confirm charges with the provider and private coverage with your insurer.
HIRA guidance ↗Authorization
MFDS 23-511, April 2023 · Innovative device No. 25 · CE(MDR), 2025
Platform
DrugOS™ · CBT-I