Merck, Lundbeck say higher-dose gaboxadol shows deep-sleep potential

By Elaine Rigoli

Tampa, Fla., June 21 - Merck & Co., Inc. and H. Lundbeck A/S said the results from phase 2 studies suggested that experimental insomnia drug gaboxadol improved deep sleep in primary insomnia patients and also improved deep sleep and key sleep measures in transient insomnia patients.

Results from study 1 showed that gaboxadol 10 and 20 mg, when compared to a placebo, increased slow-wave activity by a rate of 33% and 54%, respectively, and increased theta activity by a rate of 24% and 34%, respectively.

Slow waves are the characteristic and predominant waveform during sleep stages 3 and 4. Combined sleep stages 3 and 4 are commonly known as slow-wave sleep, according to a news release.

Study 2 evaluated 26 patients treated with gaboxadol (5 and 15 mg) and a placebo in a three-way cross-over trial, which suggested that the higher-dose gaboxadol increased slow-wave activity by 21% relative to a placebo and increased theta activity by 20% relative to a placebo, with no significant effect at the 5 mg dose.

Gaboxadol also improved deep sleep and key sleep measures in transient insomnia in a randomized, double-blind, five-way cross-over study of 109 healthy subjects aged 18 to 58 years, which evaluated the efficacy of gaboxadol (5, 10 and 15 mg).

On self-reported measures, subjects who were administered gaboxadol 10 and 15 mg reported improvements in the time it took them to fall asleep (34%, 29.2 minutes; 27%, 32.2 minutes; placebo 44.4 minutes).

Gaboxadol 5 mg did not demonstrate a significant effect, the release said.

Merck is a global research-driven pharmaceutical company based in Whitehouse Station, N.J.

Lundbeck is an international pharmaceutical company based in Copenhagen, Denmark.

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