Table 1.
Products identified by database and website search
| Product | Manufacture | Primary Indication | Regulatory Agency | Classification | Authorization Year | Prescription | Price (Patients’ copay) |
|---|---|---|---|---|---|---|---|
| Somryst® | Pear Therapeutics (Product acquired by Nox Health) | Chronic Insomnia | FDA (US) | Class II, 510(k) | 2020 | Required | $899 ($100-$899) |
| Sleepio® | Big Health | Insomnia | NICE (UK) | Recommendation | 2022 | Not required | £45 (£0 - £45) |
| Somnio® | mementor DE GmbH (Company acquired by Resmed) | Insomnia | BfArM (DE) | Permanently listed in DiGA | 2022 | Required | €224.99 (Free) |
| SUSMED Med CBT-I® | SUSMED, Inc. | Insomnia | PMDA (JP) | Class II | 2023 | Required | TBD |
| Somzz® | AIMMED co., Ltd. | Insomnia | MFDS (KR) | Innovative medical device | 2023 | Required | TBD |
| WELT-I® | WELT Corporation | Insomnia | MFDS (KR) | Innovative medical device | 2023 | Required | TBD |
Abbreviations: BfArM: Bundesinstitut für Arzneimittel und Medizinprodukte; FDA: Food and Drug Administration; MFDS: Ministry of Food and Drug Safety; NICE: National Institute for Health and Care Excellence; PMDA: Pharmaceuticals and Medical Devices Agency