Assessment of efficacy and safety of haloxazolam in psychiatric patients with insomnia

Background: To assess the usefulness of haloxazolam (Somelin®), we evaluated the efficacy and safety of the drug in psychiatric patients with insomnia as an open trial manner. Methods: Haloxazolam (5 mg h.s.) was repeatedly administered to 38 subjects for the first week, and another dose was added to the previous one (total 10 mg) during the next week in 10 patients whose insomnia had not been improved. Five-point global improvement scaling and 4 point safety scaling were performed before, 1 day, 3 days and 7 days after haloxazolam administration. Clinical utility as 5 point scale was assessed from both global improvement and safety scales. Result: The mean time to sleep induction was decreased from 118.3 min. to 77.6 min. and 57.2 min. at 1st day and 7th day of haloxazolam administration, respectively. The number of awakenings in a night was decreased from 2.3 to 1.2 and 0.9 at 1st day and 7th day. The total duration of awakening was decreased from 84.8 min. to 52.4 min. and 24.9 min. at 1st and 7th day, respectively. Total sleep time was increased from 5.3 hours to 6.3 hours at 1st day and 6.7 hour at 7th day. All of these findings were statistically significant (p < 0.01). Haloxazolam improved insomnia in 72.3% of the patients and it was proved to be useful in 66.7% of them. Side effects were developed in 15.8% of the patients and those were mild and tolerable. Conclusion: Haloxazolam proved to be useful in the management of insomnia in patients with some psychiatric disorders. The use of haloxazolam in many other medical and psychiatric conditions in general will need further evaluation on its clinical efficacy.