Methods and compositions for improving sleep

Details Methods and compositions for improving sleep Methods and compositions for improving sleep

2001-02-22

2003-07-01

Webman, Edward J. (Department: 1617)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

C-o-group doai

C514S464000, C514S564000, C514S018700, C514S664000, C514S259500, C514S263370, C514S401000, C514S247000, C514S355000, C514S502000, C514S562000, C514S236800, C514S408000, C514S236200, C514S674000, C514S258100, C514S424000, C514S248000, C514S283000, C514S261100, C514S262100, C514S299000, C514S303000, C514S923000

Reexamination Certificate

active

06586478

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to methods and compositions for improving sleep in individuals suffering from sleep disorders (SDs) and other conditions which interfere with sleep. More particularly, the present invention relates to methods of improving sleep in individuals through administration of low doses of nitric oxide-mimetics (NO-mimetics).
BACKGROUND OF THE INVENTION
Sleep is a complex process with many parts of the nervous system being involved in controlling it and influencing its different stages. Stages or levels of sleep include drowsiness, light sleep, deep sleep, and dream sleep. It is possible to identify which stage of sleep a person is in by measuring different activities of the brain (central nervous system) and body (peripheral nervous system).
For most people, falling asleep and staying asleep are parts of a natural process. Good sleepers are likely to have developed certain lifestyle and dietary habits that promote sound sleep. These habits or behaviors, known as sleep hygiene, can have positive effects on sleep before, during, and after time spent in bed. For other people, particularly those suffering from a sleep disorder, problems falling asleep and staying asleep have a large negative impact on their lives.
Sleep disorders (SDs) are diagnosed and treated by many different healthcare providers, including general practitioners and specialists in neurology, pulmonary medicine, psychiatry, psychology, pediatrics and other fields. The International Classification of Sleep Disorders (ICSD) has over seventy sleep disorders listed, and includes, THE DYSSOMNIAS: Intrinsic Sleep Disorders (Psychophysiological Insomnia, Sleep State Misperception, Idiopathic Insomnia, Narcolepsy, Recurrent Hypersomnia (excessive sleepiness), Idiopathic Hypersomnia, Posttraumatic Hypersomnia, Obstructive Sleep Apnea Syndrome, Central Sleep Apnea Syndrome, Central Alveolar Hypoventilation, Periodic Limb Movement Disorder (PLM), Restless Leg Syndrome (RLS), and Intrinsic Sleep Disorder Not Otherwise Specified (NOS)), Extrinsic Sleep Disorders (Inadequate Sleep Hygiene, Environmental Sleep Disorder, Altitude Insomnia, Adjustment Sleep Disorder, Insufficient Sleep Syndrome, Limit-Setting Sleep Disorder, Sleep-Onset Association Disorder, Food Allergy Insomnia, Nocturnal Eating/Drinking Syndrome, Hypnotic-Dependent Sleep Disorder, Stimulant-Dependent Sleep Disorder, Alcohol-Dependent Sleep Disorder, Toxin-Induced Sleep Disorder, and Extrinsic Sleep Disorder Not Otherwise Specified (NOS)), Circadian Rhythm Sleep Disorders (Time-Zone Change (Jet-Lag), Syndrome Shift-Work Sleep Disorder, Irregular Sleep/Wake Pattern, Delayed Sleep-Phase Syndrome, Advanced Sleep-Phase Syndrome, Non-24-Hour Sleep/Wake Disorder, and Circadian Rhythm Sleep Disorder Not Otherwise Specified (NOS)); and THE PARASOMNIAS: Sleep/Wake Transition Disorders (Rhythmic Movement Disorder, Sleep Starts (Hypnic Jerks), Sleep Talking, and Nocturnal Leg Cramps (Nocturnal Myoclonus), Arousal Disorders (Confusional Awakenings (Sleep Drunkenness), Sleepwalking (Somnambulism), and Night Terrors (Pavor Nocturnus, Incubus Attacks)), Parasomnias Usually Associated With REM Sleep (Nightmares Sleep Paralysis, Impaired Sleep-Related Penile Erections, Sleep-Related Painful Erections, REM Sleep-Related Sinus Arrest, and REM Sleep Behavior Disorder), Other Parasomnias (Sleep Bruxism (Teeth Grinding), Sleep Enuresis (Bed Wetting), Sleep-Related Abnormal Swallowing Syndrome, Nocturnal Paroxysmal Dystonia, Sudden Unexplained Nocturnal Death Syndrome, Primary Snoring Infant Sleep Apnea, Congenital Central Hypoventilation Syndrome, Sudden Infant Death Syndrome (SIDS), Benign Neonatal Sleep Myoclonus, and other Parasomnias Not Otherwise Specified (NOS)). Sleep disorders (SDs) can lead to lowered quality of life and reduced personal health. They endanger public safety by contributing to traffic and industrial accidents. These disorders can lead to problems falling asleep and staying asleep, difficulties staying awake or staying with a regular sleep/wake cycle, sleepwalking, bedwetting, nightmares, and other problems that interfere with sleep. Some sleep disorders can be life-threatening.
There are many limitations to the use of sleeping pills. While pills may help, for example, to aid sleeping during an overnight airplane ride or in a crisis situation to prevent an acute sleeping problem from turning into chronic insomnia, in general, the long-term use of sleeping pills has more risks than benefits. Today, most insomnia patients are not given sleeping pills, and most insomnia patients who do take drugs use them only briefly. Instead, long-term users usually have either a generalized anxiety disorder or a chronic physical illness exacerbated by anxiety, such as arthritis or heart disease.
The drugs used to induce drowsiness (hypnotics and sedatives) are often the same as those used to relieve anxiety (anxiolytics). Today, the most popular anxiety relievers and sleep inducers are the benzodiazepines, which enhance the effect of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). The benzodiazepines used as sleeping pills include diazepam (VALIUM) and temazepam (RESTORIL). However, development of tolerance to their effects often renders these drugs ineffective within a few weeks. Zolpidem (AMBIEN) is a short-acting drug that is not a benzodiazepine but has a similar mechanism of action. Preparations containing antihistamines are sold over the counter under such names as NYTOL and SOMINEX. They are fairly safe and may be useful, but tolerance may develop quickly. For depression associated with disturbed sleep, sedative antidepressant drugs such as amitriptyline (ELAVIL) and trazodone (DESYREL), are often prescribed. Antipsychotic drugs (neuroleptics) may provoke sleep in anxious, hallucinating manic or schizophrenic patients. Dopaminergic agents such as levadopa/carbidopa, bromocriptine mesylate (PARLODEL, a D
2
receptor agonist), and pergolide (a D
1
/D
2
receptor agonist) have been suggested for use in sleep disorders such as restless leg syndrome (RLS). Opioids such as codeine, propoxyphene, oxycodone, pentazocrine, hydrocodone, and methadone have also been prescribed for patients with severe and relentless symptoms of RLS. However, these drugs are also unfortunately frequently associated with undesirable side effects. The opioids can be addictive and are generally not prescribed for people with a history of addictive behavior. Many people on levodopa therapy may experience what is known as an “augmentation” effect: symptoms begin to occur and intensify during the afternoon or early evening, even though relief is felt at night.
Thus, there is a need for a drug treatment which improves sleep in individuals suffering from sleep disorders and other conditions which interfere with normal sleep that does not exhibit undue side effects.
SUMMARY OF THE INVENTION
According to a broad aspect, the present invention provides a method of improving sleep in an individual in need of such treatment comprising administering to the individual a NO-mimetic in an amount therapeutically effective to improve sleep. The NO-mimetic can be administered to an individual to treat a diagnosed sleep disorder, preferably a dyssomnia. The NO-mimetic can also be administered to improve sleep in an individual suffering from a condition such as fibromyalgia or a peripheral sensory neurogenic syndrome such as restless leg syndrome or diabetic neuropathy, wherein normal sleep is interrupted or interfered with. In a preferred embodiment, the NO-mimetic is administered at an amount therapeutically effective to improve sleep, but ineffective to appreciably alter systemic vascular tone in the individual. Thus, in this present invention, preferred amounts of NO-mimetic therapeutically effective to improve sleep are less than an amount effective to induce systemic vascular dilation or used to manage the symptoms associated with angina pectoris or congestive heart failure. Preferably, a NO-mimetic is administered in an amount between about one half (&

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