On Aug. 8, 2024, Big Health announced it received FDA clearance for its digital therapeutic, SleepioRx, for the treatment of chronic insomnia as an adjunct to usual care in adults.
About SleepioRx
SleepioRx is a prescription device that delivers cognitive behavioral therapy for insomnia (CBT-I). It is a software-based mobile app that provides a computerized version of CBT-I to the patient.
The digital therapy delivers evidence-based techniques targeting the cognitive and behavioral factors impacting chronic insomnia. It’s designed for a clinician to educate a patient about the product, then check in to review treatment progress. The patient’s experience may be tailored based on symptoms and daily sleep tracking. It is intended as a 90-day treatment.
According to the company’s press release, SleepioRx has been evaluated in over 25 clinical trials and demonstrated efficacy in addressing chronic sleep issues and insomnia disorder.
SleepioRx is based on Big Health’s existing product, Sleepio, a digital sleep improvement program that uses cognitive-behavioral techniques.
SleepioRx is intended as an adjunct to clinician-supervised treatment, providing patients access to therapy tools used during treatment sessions.
About chronic insomnia
Chronic insomnia is a sleep disorder characterized by persistent difficulties in falling or staying asleep, resulting in disrupted sleep patterns and daytime symptoms. It significantly impacts various aspects of life, affecting work performance, decision-making, relationships, mood and overall quality of life. Approximately 10% of individuals experience chronic insomnia, defined by sleep disturbances occurring at least three times a week and lasting for a minimum of three months.
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