Method of treating insomnia

Abstract

Methods for treating insomnia are disclosed. The methods are directed to administering a pharmaceutically effective amount of phosphodiesterase 5 (PDE5) inhibitor to a male individual suffering from insomnia. In addition, due to the PDE5 inhibitor positive effects on addressing erectile dysfunction (ED) in males, the present methods are directed to treating insomnia in patients that also suffer from ED by administering a pharmaceutically effective amount of a PDE5 inhibitor.

1 . A method of treating insomnia in a subject, the method comprising:
 administering a pharmaceutical composition comprising an effective amount of a phosphodiesterase 5 (PDE5) inhibitor and at least one further therapeutic agent to a subject in need thereof; and   engaging in an orgasm achieving activity, and achieving orgasm.   
     
     
         2 . The method of  claim 1 , wherein the subject achieves post orgasmic sedation, recovery phase sedation, somnolence, or sleep. 
     
     
         3 . The method of  claim 1 , wherein the PDE5 inhibitor is sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast, icariin, benzamidenafil or a salt thereof. 
     
     
         4 . The method of  claim 1 , wherein the PDE5 inhibitor is sildenafil citrate. 
     
     
         5 . The method of  claim 1 , wherein the at least one further therapeutic agent treats insomnia and/or enhances sleep quantity. 
     
     
         6 . The method of  claim 5 , wherein the at least one further therapeutic agent is selected from the group consisting of anxiolytics, antidepressants, benzodiazepine hypnotics, non-benzodiazepine hypnotics, sedatives, antihypertensives, analgesics, dopaminergic, agonists, antipsychotics, minor tranquilizers, anorectics, anti-inflammatories, and any combination thereof. 
     
     
         7 . The method of  claim 1 , wherein the at least one further therapeutic agent is selected from the group consisting of adinazolam, allobarbital, alonimid, alprazolam, amitriptyline, amobarbital, amoxapine, bentazepam, benzoctamine, brotizolam, bupropion, busprione, butabarbital, butalbital, capuride, carbocloral, chloral betaine, chloral hydrate, chlordiazepoxide, clomipramine, cloperidone, clorazepate, clorethate, clozapine, cyprazepam, desipramine, dexclamol, diazepam, dichloralphenazone, divalproex, diphenhydramine, doxepin, estazolam, ethchlorvynol, etomidate, fenobam, flunitrazepam, flurazepam, fluvoxamine, fluoxetine, fosazepam, glutethimide, halazepam, hydroxyzine, imipramine, lithium, lorazepam, lormetazepam, maprotiline, mecloqualone, mephobarbital, meprobamate, methaqualone, midaflur, midazolam, nefazodone, nisobamate, nitrazepam, nortriptyline, oxazepam, paraldehyde, paroxetine, pentobarbital, perlapine, perphenazine, phenelzine, phenobarbital, prazepam, promethazine, propofol, protriptyline, quazepam, reclazepam, roletamide, secobarbital, sertraline, suproclone, temazepam, thioridazine, tracazolate, tranylcypromaine, trazodone, triazolam, trepipam, tricetamide, triclofos, trifluoperazine, trimetozine, trimipramine, uldazepam, valproate, venlafaxine, zaleplon, zolazepam, zolpidem, zopiclone and salts thereof, and any combination thereof. 
     
     
         8 . The method of  claim 1 , wherein administration of an effective amount of a phosphodiesterase 5 (PDE5) inhibitor to a subject in need thereof further treats erectile dysfunction (ED). 
     
     
         9 . The method of  claim 1 , wherein insomnia is associated with sleep onset, difficulty falling asleep, sleep maintenance, difficulty staying asleep, early morning awakening, waking up too early, nonrestorative sleep or poor quality sleep. 
     
     
         10 . The method of  claim 1 , wherein insomnia is middle insomnia, chronic insomnia, acute insomnia, or primary insomnia co-morbid with another condition. 
     
     
         11 . The method of  claim 1 , wherein insomnia is primary insomnia co-morbid with erectile dysfunction. 
     
     
         12 . The method of  claim 1 , wherein the administering step is selected from the group consisting of oral administration, sublingual administration, buccal administration, transdermal administration, nasal administration, subcutaneous administration and intramuscular administration. 
     
     
         13 . The method of  claim 12 , wherein the administering step comprises the use of a dosage form selected from the group consisting of a transmucosal tablet, a liquid, a capsule and a film. 
     
     
         14 . The method of  claim 1 , wherein the effective amount of the phosphodiesterase 5 (PDE5) inhibitor is between 1 mg and 120 mg. 
     
     
         15 . (canceled) 
     
     
         16 . (cancelled) 
     
     
         17 . (canceled) 
     
     
         18 . (cancelled) 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the pharmaceutical composition is administered in the form of a delayed release formulation. 
     
     
         21 . A method of treating insomnia in a subject, the method comprising:
 providing a pharmaceutical composition comprising an effective amount of a phosphodiesterase 5 (PDE5) inhibitor and at least one further therapeutic agent to a subject in need thereof; and   instructing the subject to engage in an orgasm achieving activity until an orgasm is achieved.   
     
     
         22 . The method of  claim 21 , wherein the at least one further therapeutic agent is selected from the group consisting of anxiolytics, antidepressants, benzodiazepine hypnotics, non-benzodiazepine hypnotics, sedatives, antihypertensives, analgesics, dopaminergic, agonists, antipsychotics, minor tranquilizers, anorectics, anti-inflammatories, and any combination thereof. 
     
     
         23 . The method of  claim 21 , wherein the at least one further therapeutic agent is selected from the group consisting of adinazolam, allobarbital, alonimid, alprazolam, amitriptyline, amobarbital, amoxapine, bentazepam, benzoctamine, brotizolam, bupropion, busprione, butabarbital, butalbital, capuride, carbocloral, chloral betaine, chloral hydrate, chlordiazepoxide, clomipramine, cloperidone, clorazepate, clorethate, clozapine, cyprazepam, desipramine, dexclamol, diazepam, dichloralphenazone, divalproex, diphenhydramine, doxepin, estazolam, ethchlorvynol, etomidate, fenobam, flunitrazepam, flurazepam, fluvoxamine, fluoxetine, fosazepam, glutethimide, halazepam, hydroxyzine, imipramine, lithium, lorazepam, lormetazepam, maprotiline, mecloqualone, mephobarbital, meprobamate, methaqualone, midaflur, midazolam, nefazodone, nisobamate, nitrazepam, nortriptyline, oxazepam, paraldehyde, paroxetine, pentobarbital, perlapine, perphenazine, phenelzine, phenobarbital, prazepam, promethazine, propofol, protriptyline, quazepam, reclazepam, roletamide, secobarbital, sertraline, suproclone, temazepam, thioridazine, tracazolate, tranylcypromaine, trazodone, triazolam, trepipam, tricetamide, triclofos, trifluoperazine, trimetozine, trimipramine, uldazepam, valproate, venlafaxine, zaleplon, zolazepam, zolpidem, zopiclone and salts thereof, and any combination thereof. 
     
     
         24 . The method of  claim 21 , wherein insomnia is middle insomnia, chronic insomnia, acute insomnia, or primary insomnia co-morbid with another condition. 
     
     
         25 . The method of  claim 21 , wherein the pharmaceutical composition is provided as an oral administration, sublingual administration, buccal administration, transdermal administration, nasal administration, subcutaneous administration or intramuscular administration.