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Summary   Study Objectives  The aim of this study was to evaluate the efficacy and tolerability of novel combination naproxen sodium ( NS ) and diphenhydramine ( DPH ) in subjects with postoperative dental pain along with transient insomnia induced by 5 h sleep phase advance. The present studies aimed to demonstrate the added benefit and optimal dosages of the combination product over individual ingredients alone in improving sleep and pain.    Methods  Each of the two studies was a two‐centre, randomised, double‐blind and double‐dummy trial. In the first study, subjects were randomised into one of the following treatment arms:  NS  440 mg/ DPH  50 mg,  NS  220 mg/ DPH  50 mg,  NS  440 mg or  DPH  50 mg. In the second study, subjects received either  NS  440 mg/ DPH  25 mg,  NS  440 mg or  DPH  50 mg. The co‐primary end‐points in both studies were wake time after sleep onset ( WASO ) and sleep latency ( SL ) measured by actigraphy. Other secondary sleep and pain end‐points were also assessed.    Results  The intent‐to‐treat population included 712 and 267 subjects from studies one and two, respectively. In the first study, only the  NS  440 mg/ DPH  50 mg combination showed significant improvements in both  WASO  vs.  NS  alone (−70.3 min p = 0.0002) and  SL  vs.  DPH  alone (25.50 and 41.50 min respectively, p &lt; 0.0001). In the second study, the  NS  440 mg/ DPH  25 mg combination failed to show any significant improvements vs. either component alone.    Conclusions  Only the  NS  440 mg/ DPH  50 mg combination demonstrated improvement in both sleep latency vs.  DPH  50 mg and sleep maintenance ( WASO ) vs.  NS  440 mg. There were no serious or unexpected adverse events reported in either study.  Clinical Trial Registration :  NCT 01280591 (study 1);  NCT 01495858 (study 2)

international journal of clinical practice

Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia