OBJECTIVE: To examine the therapeutic potential of stochastic vibrotactile stimulation (SVS) as a complementary non-pharmacological intervention for withdrawal in opioid-exposed newborns. STUDY DESIGN: A prospective, within-subjects single-center study was conducted in 26 opioid-exposed newborns ( > 37 weeks; 16 male) hospitalized since birth and treated pharmacologically for Neonatal Abstinence Syndrome. A specially-constructed mattress delivered low-level SVS (30-60Hz, 10-12mum RMS), alternated in 30-min intervals between continuous vibration (ON) and no vibration (OFF) over a 6-8 hr session. Movement activity, heart rate, respiratory rate, axillary temperature and blood-oxygen saturation were calculated separately for ON and OFF. RESULTS: There was a 35% reduction in movement activity with SVS (p<0.001), with significantly fewer movement periods > 30 sec duration for ON than OFF (p = 0.003). Incidents of tachypneic breaths and tachycardic heart beats were each significantly reduced with SVS, whereas incidents of eupneic breaths and eucardic heart beats each significantly increased with SVS (p<0.03). Infants maintained body temperature and arterial-blood oxygen level independent of stimulation condition. CONCLUSIONS: SVS reduced hyperirritability and pathophysiological instabilities commonly observed in pharmacologically-managed opioid-exposed newborns. SVS may provide an effective complementary therapeutic intervention for improving autonomic function in newborns with Neonatal Abstinence Syndrome.