DTx Product Profile

Somryst®

Product Highlight

Condition targeted:

Chronic insomnia

How it works:

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst™ and use of Somryst® should be undertaken only under the supervised care of a Health Care Provider.

Somryst delivers digital Cognitive Behavioral Therapy for Insomnia (CBT-I) therapeutic content. CBT-I is a neurobehavioral treatment which focuses on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate sleep problems, regardless of the original source of the sleep problem.

Impact:

In a clinical trial, Somryst patients experienced: – 45% in the amount of time it took to fall asleep – 52% reduction in the amount of time spent awake at night – 45% reduction in the severity of insomnia symptoms

Product Overview

Medical condition:

Chronic insomnia

Target patient population:

Patients 22 years of age and older with chronic insomnia.

What to expect:

Improving a patient’s insomnia symptoms.

Clinical Overview

Indications for use:

Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia — CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst® treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

Outcomes:

Use of Somryst can result in significant and lasting improvements to insomnia symptoms for your patients. Results from the Somryst Pivotal Studies showed patients experience a significant reduction in severity of insomnia after treatment, with more than 40% of the patient group no longer meeting the criteria for insomnia.

Directions:

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only.
Somryst is comprised of 6 treatment Cores focused on CBT-I concepts, such as Sleep Restriction & Consolidation, Stimulus Control and Cognitive Restructuring.
Patients should complete a dose of all 6 treatment Cores. Patients who have completed all 6 Cores have shown the best outcomes. Each core should be completed on a frequency of one core every 7 days.
Patients should complete their Sleep Diary daily and follow the sleep restriction window recommendations provided by Somryst.

Risks & warnings:

Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone. Patients with the following conditions or disorders should not use Somryst:

Important Safety Information for Clinicians:

Note: In the early stages of treatment, increased daytime sleepiness may be expected, but is usually temporary. Please instruct the patient to consult with their HCP if these experiences do not go away over a few weeks, as it may indicate that they have another sleep disorder or medical condition other than insomnia. Please instruct the patient that if they have trouble staying awake while performing potentially dangerous tasks (like driving) at any point in the treatment, to avoid these dangerous tasks or stop following the sleep restriction component of the therapy. Please instruct the patient to read and follow the instructions provided in each module, and to stay with the therapy until the end to achieve the best results with Somryst. Please instruct the patient that it is important to give honest and accurate answers when reporting sleep results.

Place in therapy:

Complementary to current therapy. Outpatient treatment.

Product Access

Product description:

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst™ and use of Somryst® should be undertaken only under the supervised care of a Health Care Provider.

Somryst delivers digital Cognitive Behavioral Therapy for Insomnia (CBT-I) therapeutic content. CBT-I is a neurobehavioral treatment which focuses on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate sleep problems, regardless of the original source of the sleep problem.

Prescription status:

A prescription is required.

Patient access:

Patients download the Somryst app through the Apple App Store or Google Play Store on their smartphone or tablet. An access code is given to them at the time of prescription.

The Somryst app is supported on the following mobile operating systems:

Patients should have access to a smartphone or tablet. Patients should be able to upload data periodically, i.e. have internet/wireless connection access.

Provider access:

Healthcare providers may review the patient’s use of Somryst as well as their Sleep Windows, Sleep Efficiency, Insomnia Severity Index, Sleep Onset Latency, Wake After Sleep Onset, and Patient Health Questionnaire-8 (PHQ8) via the Somryst® Clinician Dashboard.

The Somryst Clinician dashboard is optimized for desktop computer access and is supported on the following web browsers:

Coverage options:

Plans or self-insured employers that cover Somryst may provide coverage as either a pharmacy or medical benefit. Co-payments, co-insurance, and deductibles may apply.

Product availability:

Somryst is available in:

USA: FDA-cleared Class II Medical Device, 21 CFR 882.5801 Computerized behavioral therapy device for psychiatric disorders

Unique Features

Somryst is the first FDA-cleared prescription digital therapeutic for chronic insomnia.

Clinical Trials

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