MRA was eva luated in three clinical trials in patients with insomnia characterized by difficulties with sleep onset and sleep maintenance.
Two similarly designed, 3-month, randomized, double-blind, placebo-controlled, parallel-group studies were conducted (Study 1 and Study 2). In both studies, non-elderly (age 18-64) and elderly (age ≥ 65) patients were randomized separately. For the studies together, non-elderly adults (mean age 46 years; 465 females, 275 males) were treated with BELSOMRA 20 mg (n=291) or placebo (n=449). Elderly patients (mean age 71 years, 346 females, 174 males) were treated with BELSOMRA 15 mg (n=202) or placebo (n=318).
In Study 1 and Study 2, BELSOMRA 15 mg or 20 mg was superior to placebo for sleep latency as assessed both objectively by polysomnography (Table 3) and subjectively by patient-estimated sleep latency (Table 4). BELSOMRA 15 mg or 20 mg was also superior to placebo for sleep maintenance, as assessed both objectively by polysomnography (Table 5) and subjectively by patient-estimated total sleep time (Table 6). The effects of BELSOMRA at night 1 (objective) and week 1 (subjective) were generally consistent with later time points. The efficacy of BELSOMRA was similar between women and men and, based on limited data, between Caucasians and non-Caucasians. Twenty seven percent of patients treated with BELSOMRA 15 mg or 20 mg in Study 1 and Study 2 were non-Caucasians. The majority (69%) of the non-Caucasian patients was Asian.
Table 3: Polysomnographic Assessment of Time to Sleep Onset in Studies 1 and 2
Change from baseline and treatment differences based upon estimated means.
15 mg in elderly and 20 mg in non-elderly patients
p<0.05; **p<0.01; ***p<0.001
Table 4: Patient-estimated Time to Sleep Onset in Studies 1 and 2
Table 5: Polysomnographic Assessment of Sleep Maintenance (Wake After Sleep Onset) in Studies 1 and 2
Change from baseline and treatment differences based upon estimated means.
15 mg in elderly and 20 mg in non-elderly patients
p<0.05; **p<0.01; ***p<0.001
Table 6: Patient-estimated Total Sleep Time in Studies 1 and 2
Change from baseline and treatment differences based upon estimated means.
15 mg in elderly and 20 mg in non-elderly patients
p<0.05; **p<0.01; ***p<0.001
In the 1-month crossover study (Study 3), non-elderly adults (age 18-64 years, mean age 44 years) were treated with placebo (n=249) and BELSOMRA at a dose of 10 mg (n=62), 20 mg (n=61), or up to 80 mg. BELSOMRA 10 mg and 20 mg were superior to placebo for sleep latency and sleep maintenance, as assessed objectively by polysomnography.
BELSOMRA was also eva luated at doses of 30 mg and 40 mg in the 3-month placebo-controlled trials (Study 1 and Study 2). The higher doses were found to have similar efficacy to lower doses, but significantly more adverse reactions were reported at the higher doses.
14.2 Special Safety Studies
Effects on Driving
Two randomized, double-blind, placebo- and active-controlled, four-period crossover studies eva luated the effects of nighttime administration of BELSOMRA on next-morning driving performance 9 hours after dosing in 24 healthy elderly subjects (≥65 years old, mean age 69 years; 14 men, 10 women) who received 15 mg and 30 mg BELSOMRA, and 28 non-elderly subjects (mean age 46 years; 13 men, 15 women) who received 20 mg and 40 mg BELSOMRA. Testing was conducted after one night and after 8 consecutive nights of treatment with BELSOMRA at thes |
