0468 A Multiple Dose, Placebo-Controlled, Randomized Double-Blind, Multicenter Study to Investigate Triprolidine in the Treatment of Temporary Sleep Disturbance

Abstract

Introduction: American Association of Sleep Medicine guidelines states that the primary goals of the treatment of insomnia are to improve sleep quality and related daytime function. While H1 antihistamines have sedative effects, they are associated with residual daytime sleepiness and an effective dose range for hypnotic effect has hitherto not been established. Triprolidine a first generation antihistamine used to treat allergic rhinitis and the common cold has a mean half‐life of 3.2 hours. We evaluated the effect of two doses of triprolodine compared with placebo on sleep onset latency and daytime sleepiness to determine the optimum dose in subjects with temporary sleep disturbance. Methods: Multicenter, placebo‐controlled, parallel group, double blind, multiple dose, randomized study of 178 patients aged 18 years or above with a primary diagnosis of temporary sleep disturbance. Patients were randomized to one of three groups. Group 1: 2 x placebo tablets; Group 2: 1 x placebo tablet + 1 x 2.5mg triprolidine tablet; Group 3: 2 x 2.5mg triprolodine tablets, taken 20 minutes before intended sleep on three consecutive evenings. Efficacy was measured objectively using the Sleep Disturbance Index using a wrist actimeter and subjectively using the Loughborough Sleep Log and Karolinska Sleepiness Scale. Results: Both doses were statistically significantly superior to placebo in terms of quality and duration of sleep and sleep interruptions. No hangover effects or daytime sleepiness were observed with either dose compared to placebo. Patients on the 2.5 mg dose awoke more refreshed than the 5 mg dose. No serious adverse effects observed in any group and anticholinergic events i.e. dry mouth were very low. Conclusion: Tripolidine is effective and safe in the treatment of temporary sleep disturbance. The optimum dose is 2.5mg.