- Somryst® is the only FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia
- Analysis demonstrated potential per-patient cost reductions over 24 months of $8,202 compared to use of insomnia medications alone
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced results from a retrospective analysis to evaluate the impact of Somryst® on healthcare resource use (HCRU).1 Results found that use of Somryst, the only FDA-authorized PDT for the treatment of chronic insomnia, was associated with significant and durable real-world HCRU reductions and cost savings compared to sleep medicines alone.2 These findings were presented as a poster at ISPOR Europe 2022 held November 6-9, 2022, in Vienna, Austria and virtually, and were previously presented at AMCP Nexus 2022 in October and the 2022 NEI Congress earlier this month.
“Chronic insomnia is a significant public health problem associated with increased hospital inpatient and outpatient stays and visits to the emergency department, posing a substantial economic burden on patients and healthcare organizations,” said Yuri Maricich, MD, MBA, Chief Medical Officer, Pear Therapeutics. “The significant reduction of per-patient cost savings seen with Somryst usage compared to patients treated with pharmacotherapy further underscores the potential clinical utility and durable economic benefit of PDTs for people with chronic insomnia.”
The analysis evaluated real-world data of 248 adult patients with chronic insomnia treated with Somryst over 24-months compared to matched controls treated with chronic insomnia medications and found: 2
- Reductions in health-related services including:
- Emergency department services (59%; IRR =0.41; P<0.001).
- Hospitalizations (55%; IRR =0.45; P=0.001).
- Hospital outpatient visits (36%; IRR =0.64; P<0.001).
- Ambulatory surgical center services (23%; IRR =0.77).
- Office visits (7%; IRR =0.93).
- An estimated $8,202 reduction in per-patient costs were observed compared to controls treated with chronic insomnia medications.
For more information and to view the poster, please visit www.ispor.org.
Somryst is the only FDA-authorized therapeutic that delivers guideline recommended first-line treatment for chronic insomnia. Somryst is a 9-week prescription digital therapeutic (PDT) that addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain to sleep. The American Academy of Sleep Medicine and the American College of Physicians clinical guidelines recommend CBTi as first-line treatment for people with chronic insomnia.2,3 Somryst is used on a mobile device, such as a smartphone or tablet and 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.
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 Health Care Provider 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. 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, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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.
The data analyzed pertained to the use of SHUTi, a web-based platform that was the precursor to the Somryst PDT.
Forma F, Knight TG, Baik R, Wallace M, Malone DC, Xiong X, Velez FF Thorndike FP, Maricich YA. Reduced Healthcare Resource Utilization in Patients with Chronic Insomnia 24 Months After Treatment with Digital CBT-I: A Match-Controlled Study. Poser #EE364 https://www.ispor.org/docs/default-source/euro2022/isporeu22formashuti24movscontrolee364-pdf.pdf?sfvrsn=5eff60d2_0. ISPOR Europe 2022.