Nov. 17, 2020 13:00 UTC
BOSTON & SAN FRANCISCO–(BUSINESS WIRE)– Pear Therapeutics, Inc., today announced the availability of Somryst™,the first prescription digital therapeutic (PDT) intended for use in the treatment of patients 22 years of age and older with chronic insomnia. Somryst addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain and body to sleep. Somryst will be promoted via a fully virtual experience, combining telemedicine visit(s) and PDT prescribing and dispensation via PearConnect™.
Somryst is a digital treatment that has been shown to improve the symptoms of chronic insomnia. Over 6 to 9 weeks, depending on a patient’s pace, the program takes them through short lessons and challenges, including algorithm-driven sleep restriction, to train the brain and body to improve their sleep, while also providing clinicians with real-time data on patient progress via physician dashboard. Research shows that PDT use correlates with lasting improvements in sleep outcomes at 12 and 18 months for people suffering from chronic insomnia.2 In clinical studies of more than 1,400 adults with chronic insomnia, the PDT reduced the amount of time it took to fall asleep by 45%, reduced the amount of time spent awake at night by 52% and reduced the severity of insomnia symptoms by 45%, with continued improvement at 6 and 12 months post treatment. Results from clinical studies have been published in JAMA Psychiatry3and Lancet Psychiatry.4,5
“Despite CBTi being the recommended first line treatment for chronic insomnia, there aren’t enough clinicians who are trained to deliver CBTi therapy. With the availability of Somryst, millions of Americans suffering from chronic insomnia now have access to this treatment,” said Dr. Michelle Primeau, M.D., Medical Director of the Palo Alto Medical Foundation Sleep Medicine Center in San Carlos, CA. “Somryst has been shown to address the underlying issues of chronic insomnia by training the brain and body to fall asleep faster and stay asleep longer. Unlike sleep medications, which may represent short- term solutions and can have unwanted side-effects, Somryst has been shown to deliver long-term results.”
At Somryst.com, individuals will be able to obtain access to a doctor who will perform an evaluation and determine whether or not an individual is a candidate for Somryst. If an individual receives a prescription, a case worker from PearConnect, the industry’s first patient service center for PDTs, will support the individual on how to download Somryst and get started. Telemedicine allows individuals suffering from chronic insomnia to get started on Somryst without leaving their home, important considering the ongoing COVID-19 pandemic.
More than 30 million Americans suffer from chronic insomnia1, and cases of chronic insomnia are increasing as Americans continue to navigate the COVID-19 pandemic. In fact, a recent survey conducted by Pear Therapeutics of 2,010 adults in the U.S. in October 2020 found that nearly 50% of U.S. adults reported that the pandemic has affected their sleep negatively, with one in four describing their quality of sleep as poor since the pandemic’s start. People with chronic insomnia are more likely to suffer from medical conditions, including chronic pain, hypertension, gastrointestinal problems and heart disease.6 Chronic insomnia can also increase an individual’s chances for developing psychiatric conditions, such as major depression, anxiety, substance use disorder and suicidal thoughts.7
“We’re excited to offer patients who have been struggling to find a long-term solution for chronic insomnia with a meaningful, first-line treatment that is accessible via an end-to-end care model, to support patients and healthcare providers during the virtual onboarding process,” said Corey McCann, President and CEO of Pear Therapeutics. “The availability of Somryst demonstrates our ongoing commitment to developing PDTs to deliver easily-accessible treatment options to patients for their chronic conditions, important now, more than ever as we continue to navigate the COVID-19 pandemic.”
To learn more, visit www.Somryst.com.
Photos and multimedia gallery available at www.PearTxMedia.com.
Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst is 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 an HCP.
Somryst Indications for Use and Important Safety Information
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.
Safety Information and Warnings
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 to 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, 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.
This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
2Batterham, P.J., Christensen, H., Thorndike, F. P., Ritterband, L.M., Gerwien, R., Enman, N., Botbyl, J., Maricich, Y. Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms. Virtual SLEEP 2020.
3Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017;74(1):68–75. doi:10.1001/jamapsychiatry.2016.3249.
4Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry 2016; 3: 333–41.
5Batterham P, Christensen H, Mackinnon A, et al. Trajectories of change and long-term outcomes in a randomized controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017; 3(5), 228-235. doi:10.1192/bjpo.bp.117.005231.