This was the first-ever Phase 3 study with pre-specified endpoints versus zolpidem ER, measuring the change from baseline in both sleep onset and sleep maintenance
variables, including the time spent awake in the second half of the night, which is a common complaint, especially in the elderly.
SAGE-217 also demonstrated statistically significant improvements in total sleep time as well as sleep maintenance
as measured by time spent awake after sleep onset, although there was not a significant impact on sleep onset in this model as measured by latency to persistent sleep.
For sleep maintenance
complaints, longer-acting/wake-inhibiting medications that work at the end of the sleep phase may be necessary.
The drug indicated strong efficacy in sleep maintenance
all through the night in comparison to placebo in the double-blind, dose-finding four-way cross-over trial held at 11 European sleep labs.
In April, the 59-year-old, from Crossgar Road East, Downpatrick, admitted two charges of "conducted a clinical trial relating to the efficacy and safety of 2mg per day of M100907 on Sleep Maintenance
Long acting hypnotics are indicated in patients with poor sleep maintenance
(early morning wakening) that causes day time effects, when an anxiolytic effect is needed during the day or when sedation the following day is acceptable.
The condition can be defined as patient-reported difficultly with sleep initiation or sleep maintenance
which can include frequent awakenings, difficulty returning to sleep after awakenings, or awakening too early with inability to return to sleep.
However, sleep maintenance
and early morning awakenings are the most common symptoms among geriatric insomnia patients.
In the study, E2006 demonstrated a statistically significant improvement in sleep initiation and sleep maintenance
without increasing next-day residual sleepiness when compared with placebo.
Silenor[R] (doxepin) is approved for the treatment of insomnia characterized by difficulty with sleep maintenance
and is not a controlled substance.
028) indicating beneficial effects on sleep maintenance
10) In a trial of more than 400 perimenopausal women who had symptoms of insomnia, eszopiclone, 3 mg nightly for 4 weeks, improved sleep onset, sleep maintenance
, sleep duration, sleep quality, and daytime functioning, also compared to placebo.