Daily Archives: June 21, 2012
An investigational insomnia drug, known as suvorexant, is reportedly ‘a new class of drug’ that works in a different way than other sleep meds – and could be THE answer for many of us having difficulty falling asleep or staying asleep through the night.
According to the results of two “pivotal” Phase III effectiveness trials, revealed June 13 at the Associated Professional Sleep Societies annual meeting, suvorexant:
- Targets insomnia in a different way than other drugs. It was developed to help facilitate sleep by targeting and blocking the actions of the orexins, chemical messengers that originate from the hypothalamus (an important sleep centre in the brain) and help to keep you awake and alert. By blocking the orexin receptors, suvorexant supposedly helps to facilitate sleep.
- Significantly reduced the time it took insomnia patients to fall asleep and increased the time they stayed asleep as early as the first night and at the three-month time point, compared to placebo.
- Produced no serious observed drug-related adverse events in either trial with any dose of suvorexant. Reports of next day residual effects on memory, attention, perceptual & motor speed, etc. were not significantly more frequent in treated subjects vs. those given placebo.
Merck plans to file a New Drug Application (NDA) for suvorexant with the US FDA in later this year. If approved, it would be the first medicine approved in the new class of medicines – called ‘orexin receptor antagonists,’ for use in patients with difficulty falling or staying asleep. If approved, it could be your dream come true!
- Merck preps FDA app after racking up positive PhIIIs on new sleep drug (fiercebiotech.com)
- Merck Sleep Drug Hits Trial Goals, Raising Hopes for New Blockbuster (xconomy.com)
- Sleep Easy, My Friend (dailyfinance.com)