Prescribing Information

CE conformity statement for Europe: The Alpha-Stim SCS is a Class IIa, Type B medical device. It has been independently tested by outside agencies in order to provide assurance of conformity to applicable standards for medical equipment safety and electromagnetic compliance.
Caution statement for United States: Federal law (USA only) restricts this device to sale by, or on the order of, a licensed health care practitioner. Outside the USA it is available world wide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems or when used with pharmaceuticals or other therapeutic intervention.
Indications: Alpha-Stim cranial electrotherapy stimulation (CES) technology is continuously being subjected to rigorous study and evaluation by the international medical community. Findings to date indicate that the Alpha-Stim SCS is an effective treatment with broad applications for a variety of anxiety disorders, or for the short term relief of the symptoms of anxiety, depression and/or insomnia. In many cases it is the sole therapeutic method required. As with any therapeutic intervention, not all people will respond to the Alpha-Stim SCS. The degree of efficacy will vary with the nature of the problem being treated and the overall health of the person.
Contraindications: Alpha-Stim SCS may affect the operation of cardiac pacemakers (particularly demand type pacemakers).
Precautions: For external use only. Do not allow children to use or handle this device without adult supervision. Do not operate potentially dangerous machinery or vehicles during, and in some cases, for several hours after treatment. Safety of stimulation has not been established during pregnancy. There have been isolated reports of blood pressure being lowered by CES so care should be taken while using the Alpha-Stim SCS with high blood pressure medication.
Adverse effects: Adverse effects are usually mild and self-limiting. Adverse effects seen in approximately 4,541 patients in controlled, open, uncontrolled conditions, and by physician survey and reasonably associated with the use of CES are dizziness (6 cases, 0.13%), skin irritation/electrode burns (5 cases, 0.11%), and headaches (9 cases, 0.20%). Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last for hours to days. Treatment immediately prior to going to sleep may cause difficulty sleeping due to increased alertness. It is recommended that CES be used at least 3 hours before going to sleep. Paradoxical reactions such as hyperexcited states, increased anxiety, and sleep disturbances may occur. If the Alpha-Stim SCS does not control your anxiety, depression and/or insomnia within 3 weeks, discontinue use and consult your physician.