Discover Nidra, now granted FDA market authorization with controlled release coming soon!

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Discover the breakthrough wearable therapy for RLS

When prescription medication is not providing comfort from RLS symptoms, Nidra offers relief in a sleek, non-invasive device, designed to be worn comfortably throughout the night.

How does Nidra work?

Nidra uses a novel technology called Tonic Motor Activation therapy (TOMAC) to stimulate the nervous system and improve symptoms of RLS when prescription medication is not providing relief.1

1. In adults with primary, moderate-severe RLS who are resistant to medications.

  • Nidra gently stimulates a nerve on the side of each leg, which sends signals to the spinal cord.
  • The spinal cord activates the muscles of the lower legs to mimic the sensation of movement.
  • Muscle activation alleviates the discomfort caused by RLS, reducing symptoms and improving sleep.

Clinically
Proven Relief

The safety and efficacy of Nidra was evaluated in people with moderate-severe RLS who are resistant to medications in the RESTFUL study and in a subsequent 6-month extension study.1,2

60 %
of people

reported an
improvement in
their symptoms
over 8 weeks.

60 %
of people

reported acute
improvement in their
symptoms following
individual sessions.

0 %
additional days

symptom-free
per month.

Nidra provides relief with ZERO serious device-related adverse events reported at 6 months.

1. Safety and efficacy were determined based on enrollment of 133 participants in the RESTFUL study and 44 participants in the 6-month extension study.
2. Noctrix Health. Data on File. CL-10 Report, Analysis of acute relief from NTX100 TOMAC.

Clinical Evidence

Explore the latest research and publications on Nidra and TOMAC therapy for RLS.

Noninvasive neuromodulation reduces symptoms of restless legs syndrome

Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms

Reduction in Restless Legs Syndrome Symptoms with Non-Invasive Peripheral Nerve Stimulation

Noninvasive peroneal nerve stimulation reduces symptoms of restless legs Syndrome

Health-Economic Implications of Defined Improvements in Restless Leg Syndrome Severity: A Model-Based Exploratory Analysis based on Prior Publication Data

Efficacy and Safety of Tonic Motor Activation (TOMAC) for Medication-refractory Restless Legs Syndrome: A Randomized Clinical Trial

Long-term Efficacy and Safety of Tonic Motor Activation (TOMAC) for Treatment of Medication-Refractory Restless Legs Syndrome: A 24-Week Open-label Extension Study

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Important Safety Information
and
Indications For Use

INDICATION
The NTX100 Tonic Motor Activation (TOMAC) System is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.*

Rx Only. Caution: Federal law restricts this device to sale by or on the order of a medical professional.
*FDA De Novo Number DEN220059

© 2023 Noctrix Health, Inc. All rights reserved.

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All information on this website is provided for informational purposes only and is not intended to be a substitute for any professional medical advice or any medical diagnosis or treatment. Nidra is intended for prescription use only and is only available for commercial sale in the United States by or on the order of a physician. Individual patient experience may vary.

Important Safety Information

IMPORTANT SAFETY INFORMATION
Contraindications
The Nidra TOMAC System is contraindicated for use in patients with the following:

  • Diagnosis of epilepsy or other seizure disorder
  • Active medical device implant anywhere in the body, including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators
  • Metal implant in the leg at the therapy site (not including knee replacements)
  • Known allergy to device materials (or severe previous reaction to medical adhesives or bandages)
  • Cellulitis, open sores, or injury at or near the location of therapy device application
  • The device cannot be used while driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury

Potential Complications
There is a potential for the following side effects, which are typically mild to moderate and resolve over time:

  • Mild skin irritation from use of adhesives.
  • Temporary interference with sleep while wearing the device. For some people, the device may be uncomfortable. For others, the device may interfere with preferred sleep positions.
  • Proper use of the device as described in the Instructions for Use (IFU) can help reduce or prevent the following complications: Discomfort, paresthesia (tingling or prickling sensation), or otherwise irritating or uncomfortable sensations during treatment. This risk is reduced by adjusting the stimulation intensity.

This list is not all inclusive. Please refer to the Instructions for Use. for all of the important warnings and precautions before using or prescribing this product.