Somryst

Indications for Use

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

Who Should Not Use Somryst (Contraindications)

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 Cognitive Behavioral Therapy for Insomnia

Important Safety Information and Indication

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.