Somryst®

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.

Note: for more information, please visit https://www.somryst.com.

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:

• Any disorder exacerbated by sleep restriction (e.g. bipolar disorder, schizophrenia, other psychotic spectrum disorders)
• Untreated obstructive sleep apnea
• Parasomnias
• Epilepsy
• Individuals at high risk of falls
• Individuals who are pregnant
• Individuals who have any other unstable or degenerative illness judged to be worsened by sleep restriction delivered as part of CBT-I

Important Safety Information for Clinicians:

• Somryst is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.
• Somryst is not for emergency use. Please instruct patients to dial 911 or go to the nearest emergency room in the event of a medical emergency.
• Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
• Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
• Somryst is not meant to be a substitution for any treatment medication.
• Somryst contains sensitive medical information. Please instruct patients to protect their information by password protecting their smartphone and tablet, and ensuring no one else may access their device.
• Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
  • Long-haul truck drivers
  • Long-distance bus drivers
  • Air traffic controllers
  • Operators of heavy machinery
  • Some assembly line jobs
• The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.

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:

• iOS
• Android

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:

• Google Chrome
• Firefox
• Microsoft Internet Explorer
• Microsoft Edge
• Safari

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

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title: Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial
  Study Design: Randomized controlled trial
  Outcomes: Improved insomnia symptom severity was observed in the study population, demonstrating efficacy of UC+SHUTi (an early version of Somryst with equivalent content) in reducing chronic insomnia symptoms. Participants who received UC+SHUTi showed statistically significant improvement in overall insomnia symptom scores, as well as the within group change in insomnia symptom scores, over UC+Control. Insomnia symptom severity was improved at the end of the treatment period and this effect was maintained to month 12 for the participants randomized to UC+SHUTi.
  Participants randomized to UC+SHUTi demonstrated more than a 7-point reduction in insomnia symptom score on average, representing a clinically significant change in insomnia severity. Furthermore, by the end of the treatment period participants receiving SHUTi no longer met the threshold for clinical insomnia. This effect of treatment was maintained up to the month 12 follow-up. In contrast, participants receiving UC+Control maintained a symptom severity status registering within the definition of insomnia, on average, at the end of the treatment period and at the month 6 follow-up.