NITRAZEPAM IN PATIENTS WITH SLEEP-APNEA - A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY

We wanted to assess whether benzodiazepines worsen sleep apnoea, since their use in such patients has been controversial. Fourteen male pati ents with mild to moderate obstructive sleep apnoea were investigated in a placebo-controlled, double-blind study evaluating the influence o f nitrazepam (NIT) on apnoea frequency and severity. Each patient was given oral nitrazepam 5 or 10 mg, or corresponding placebo, in a rando mized order on three separate nights. Wash-out time was one week. A co mplete sleep study was undertaken at each study night. Eleven patients completed the study. Although there were individuals with marked vari ability in apnoea index between the three study nights, there was no s ignificant change in apnoea index or minimum arterial oxygen saturatio n with any of the two nitrazepam dosages studied. Only 3 out of 11 pat ients had a higher apnoea index after both nitrazepam doses compared t o placebo, and in these patients the increase in sleep-disordered. bre athing was of marginal clinical significance. Nitrazepam caused a mode st increase in total sleep time and a decrease in rapid eye movement ( REM) sleep. These results demonstrate that nitrazepam does not worsen sleep apnoea in patients with mild to moderate sleep apnoea. The previ ously reported sleep apnoea promoting effects of benzodiazepines may b e restricted to a small subgroup of patients with sleep-disordered bre athing.