The Need

The market for insomnia drugs in the 7 major markets is anticipated to reach 1.8 Billion USD in 2023 (Global Data).

According to KOL’s, there is an unmet need with respect to a drug that would address the three attributes expected from an optimal insomnia drug:

  1.  Rapid sleep induction
  2.  Good sleep maintenance through the night
  3.  No “next-day” residual side effects

The majority of insomniacs experience difficulties in both falling asleep and in sleep maintenance.

The Accordion Pill- Zaleplon

Zaleplon is an effective drug for sleep onset. The Accordion Pill™-Zaleplon (AP-ZP) is designated to provide a fast onset of sleep, good sleep maintenance and to avoid “next day” residual side effects.

Gastro-retention of Zaleplon provides significantly prolonged absorption phase of the drug and reduced variability, by absorption through a defined, specific site, in the upper part of the GI tract.

The Accordion Pill™ Zaleplon, Phase II

A Double blind, Multi center, two-way crossover, randomized, placebo controlled,  PSG study. Each subject participated in 6 PSG nights, 2 each for Screening, Test formulation and Placebo, with 4-7 days of washout between treatments.  The study population was 83 male or female patients meeting DSM IV criteria for  primary insomnia with difficulties in falling and staying asleep.

The primary endpoint ofthis study was Total Sleep Time (TST) both by PSG and patient report and the key secondary endpoints were sleep induction as Latency to Persistent Sleep (LPS) followed by sleep maintenance, defined by Wake Time After Sleep Onset (WASO) and Safety evaluations

Results

TST (primary endpoint) was significantly increased both as measured by PSG as well as patient reports Secondary endpoints:

  • Sleep latency was significantly decreased as measured by PSG and patient reports.
  • WASO was significantly decreased in the first part of the night (up to hour 4).
  • Patients reported a significant improvement in sleep quality.
  • DSST, memory testing and patient reports showed an absence (even directionally) in residual effects.