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TAKE

Who Can Zleepax™ Help?

If you’ve ever woken up in the middle of the night feeling stress, struggling to fall asleep again, and then feeling even more stressed because you can’t fall asleep, you probably have stress-related insomnia, and Zleepax™ was made to help – without unpleasant side effects.

Zleepax—Treating Insomnia with Fewer Side Effects

Zleepax offers a new way of treating stress-related insomnia. It works by reducing physical stress symptoms that inhibit sleep at night4, without producing the unwanted side effects typically associated with hypnotics. This gives Zleepax the potential to become any doctor’s first line therapy for treating ordinary stressrelated insomnia.

 

The main advantage is that ZLX-1 can achieve the overall goal of a better night’s sleep without the unwanted side effects associated with traditional hypnotics.

No more residual daytime sedation. According to patients, the No. 1 problem with traditional sleeping pills is residual daytime sedation. The potential for tolerance buildup and addiction are also major perceived disadvantages3. Based on beta blockers, the Zleepax ZLX-1 formulation dramatically reduces these and many other unwanted side effects. This means that, in stark contrast to existing hypnotics, Zleepax can give many patients a better night’s sleep with fewer of the side effects they do not want.

Specifically for stress-related insomnia. Stress is one of the most common causes of insomnia4. However, the relationship between insomnia and stress is complex—with the one often causing or exacerbating the other. A divorce or financial troubles, for example, can cause stress that leads to transient insomnia. This, in turn, can make the person less able to cope during the day, creating further stress. In a vicious circle, the further stress can eventually lead to intermittent or even chronic insomnia, where many patients name stress symptoms such as a pounding heart as what keep them awake at night5.

Where traditional hypnotics “force” people to sleep by depressing the central nervous system, Zleepax acts by diminishing the physical symptoms of stress that keep people awake at night.

The first sleep aid based on beta blockers. The Zleepax ZLX-1 formulation will be the first prescription sleep aid on the market with beta blockers as the major active ingredient. First generation beta blockers, such as Propranolol and Atenolol, inhibited natural melatonin secretion and, studies show, had a negative impact on sleep6. Certain newer beta blockers, however, do not have this side effect. A pioneering 2006 study showed that Nebivolol, Carvedilol and Bisoprolol had no effect on nocturnal release of melatonin7. And more recent publications have shown that Nebivolol actually improves quality of sleep for patients with mild hypertension8.

Nebivolol has been widely used to treat hypertension since the early 1990s, is well tolerated in chronic use, has an attractive side-effect profile9, and should thus perform excellently applied as a sleep enhancer. Zleepax’s patent applications10 cover the use of beta blockers such as Nebivolol—alone or in combination with other antiinsomnia drugs—for the treatment of stress-related insomnia.

Ready for Phase II clinical testing. Because it works via pharmaceutical compounds whose safety9 and whose efficacy8 are documented in numerous clinical studies, Zleepax’s ZLX-1 formulation is ready to enter Phase II clinical testing now. Phase II clinical testing will be financed by capital raised through the company’s current investment round.