Efficacy and safety of sodium oxybate treatment in adults with narcolepsy and cataplexy: a systematic review and meta-analysis

Background and purpose: Narcolepsy is a chronic illness characterized by excessive daytime sleepiness and cataplexy. Recently, sodium oxybate (SXB) has been the only effective drug in treating multiple symptoms of narcolepsy. Our study aims to assess the effectiveness and safety of SXB in treating narcolepsy.

Method: We searched four databases for eligible studies. Our primary outcome was to investigate the effectiveness of SXB through symptom improvement. For the secondary outcome, we assess its safety through the reported adverse events.

Result: Five RCTs were included. The SXB group had significantly improved weekly cataplexy attacks better than the placebo (MD = -5.04, 95% CI [-6.35, -3.72], P < 0.00001), also the improvement in the Maintenance of Wakefulness Test, and ESS was better in the SXB group with (MD = 4.66, 95% CI: [2.24, 7.07], p = 0.0002), (MD = -1.93, 95% CI: [-2.73, -1.13], p < 0.00001) respectively. CGI-I was observed to be significantly better in the SXB group with (RR = 2.15, 95% CI: [1.69, 2.73], p < 0.00001). The weekly cataplexy attack was significantly improved by the doses (4.5, 6, and 9 gm) in comparison with the placebo, with the 9-gm dose having the most beneficial effect. The improvements were significant only in SXB 9 gm in ESS and 6 and 9 gm in CGI-I.

Conclusion: SXB is an effective pharmacological treatment for the management of narcoleptic patients with cataplexy with an acceptable safety profile. Further studies with a large scale are needed to investigate and prove the efficacy and tolerability of SXB.