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TREATMENT OF EXCESSIVE SLEEPINESS
Accurate identification of the underlying cause(s) of the patients sleepiness is critical to direct therapeutic intervention. While the principal cause may dictate the initial approach to treatment,the overall goal remains the same: to improve wakefulness/alertness and functioning. As with any treatment strategy,setting realistic goals and expectations with the patient is essential before initiating treatment of excessive sleepiness,whether behavioral or pharmacologic or a combination of both. Additionally,regular and timely follow-up is crucial to assess effectiveness of and compliance with treatment.
# Behavioral Measures to Improve Sleep
Improving duration of sleep and ensuring proper sleep hygiene (sleep-related behaviors) are essential first steps in helping to alleviate symptoms of excessive sleepiness in all patients. Patients should be encouraged to allow enough time in their schedules for an adequate amount of sleep to feel refreshed or well rested. Additionally,physicians should educate their patients on the practice of good sleep habits. These habits include maintaining a regular sleep-wake schedule (7 days a week); creating a quiet,cool,and comfortable bedroom environment that is conducive to sleep; limiting time spent in bed for activities other than sleep; and ensuring avoidance of caffeine,nicotine,alcohol,heavy meals,and strenuous exercise at least 3 hours before bedtime.
# Treatments for Underlying Sleep-Wake Disorders: Obstructive Sleep Apnea and Shift Work Disorder
Treatment of obstructive sleep apnea includes a variety of strategies depending on the severity of the condition: positional therapy,positive pressure therapy,intraoral/dental appliances (eg,mandibular advance devices),and,when craniofacial abnormalities are evident,surgery. The preferred treatment is nasal continuous positive airway pressure (nCPAP),a machine that generates an airflow administered to the patient,usually through a nasal mask. The administration of positive pressure maintains airway patency largely by creating a pneumatic splint. Proper use of nCPAP therapy corrects sleep-disordered breathing,normalizes arterial blood oxygen saturation,and improves sleep quality and blood pressure,with consequent improvement in alertness,cognitive function,mood,and quality of life. – Previous studies have shown that nCPAP use does not always return alertness to normal.
The 2003 meta-analysis by Patel et al of 12 nCPAP trials showed that nCPAP,the gold standard for treatment of patients with obstructive sleep apnea,only minimally improves subjective and objective sleepiness. Although nCPAP is effective in resolving recurrent upper airway obstruction in obstructive sleep apnea,those experiencing residual excessive sleepiness may benefit from adjunctive treatment with a wake-promoting agent.
More recent data indicate that significant proportions of patients continue to have excessive daytime sleepiness even with optimal nCPAP therapy. In a study of 149 patients with severe obstructive sleep apnea treated with nCPAP,34% of patients still had ongoing subjective sleepiness (ESS) and 65% had ongoing objective sleepiness (MSLT) after an average of 4.7 hours of nCPAP use per night for 3 months. Although these percentages decreased to 22% subjective sleepiness (ESS) and 52% objective sleepiness (MSLT) when nCPAP was used for 6 or more hours per night,they remained indicative of significant,unremitting subjective and objective daytime sleepiness despite optimal nCPAP use
For the treatment of patients with circadian rhythm disorders (eg,shift work disorder),a variety of interventions have been proposed to appropriately shift their biologic circadian rhythms,maintain sleep continuity,and improve alertness. Proposed treatments include chronobiotic interventions (eg,bright light therapy,appropriately timed melatonin administration,hypnotic agents,and wake-promoting agents). Because circadian rhythm disorders are influenced by both environmental and behavior factors,a multimodel treatment approach,including a structured sleep-wake schedule and proper sleep hygiene,is generally recommended.
# Wake-Promoting Agents
Several medications are available to improve wakefulness and alertness in patients with symptoms of excessive sleepiness. It should be noted,however,that medications are not specific to underlying disorders,and pharmacologic management of excessive sleepiness does not replace the need for sleep.
Amphetamines. Since their development in the 1930s,amphetamines have historically been used to treat excessive sleepiness and narcolepsy. Dextroamphetamine and methamphetamine,2 sympathomimetics approved by the US Food and Drug Administration (FDA) for use in narcolepsy,are fast acting and effective in ameliorating symptoms of excessive sleepiness. Methylphenidate,a psychomotor stimulant with pharmacologic mechanisms similar to amphetamine and commonly used in the treatment of attention-deficit/hyperactivity disorder,is also approved to treat narcolepsy. Few studies,however,have examined its effects on daytime excessive sleepiness.
Commonly reported side effects of these stimulants include anxiety,agitation,anorexia,tachycardia,and elevated blood pressure. At high doses,hallucinations and psychosis may occur. Additionally,patients treated with these stimulants may require increasingly greater doses to sustain improvements in alertness,and tolerance and tachyphylaxis may occur over time. On the basis of their higher potential for abuse,these US Drug Enforcement Administration schedule II medications require careful patient monitoring and should be used with caution.
Modafinil and armodafinil. Modafinil is a wake-promoting agent that is structurally and pharmacologically distinct from traditional CNS stimulants. It also has a lower abuse potential and lower risk for adverse cardiovascular events than sympathomimetic agents. Additionally,because of its negligible sympathomimetic activity,modafinil does not adversely affect nighttime sleep when used as directed.
Armodafinil is the R-enantiomer of modafinil and has been shown in double-blind studies to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea,shift work disorder,and narcolepsy. – These studies have also shown that armodafinil improves wakefulness later during the day on an extended MWT and that it improves fatigue as shown by the Brief Fatigue Inventory. Armodafinil was approved by the FDA in 2007.
Modafinil and armodafinil are both approved for use in patients with excessive sleepiness associated with narcolepsy,obstructive sleep apnea (as an adjunct to nCPAP),or shift work disorder. For patients with excessive sleepiness due to narcolepsy,modafinil is recommended as a “standard” treatment by the American Academy of Sleep Medicine. For obstructive sleep apnea and shift work disorder,modafinil and armodafinil are the only FDA-approved agents for the excessive sleepiness associated with these disorders.
In several modafinil and armodafinil double-blind,placebo-controlled studies in volving more than 2,200 patients with excessive sleepiness associated with these disorders,– – both agents consistently improved objective and subjective sleepiness,as demonstrated by improved MSLT or MWT sleep latencies and ESS or KSS assessments,respectively. The medications also improved the ability to sustain attention,overall clinical condition,and health-related quality of life in patients with excessive sleepiness associated with narcolepsy,obstructive sleep apnea,and shift work disorder. In addition to the improvements in alertness in shift work disorder patients following treatment with modafinil and armodafinil,proportionately fewer modafinil-treated and armodafinil-treated patients reported having accidents or near accidents on the commute home.
Importantly,when used as an adjunct to nCPAP to treat residual excessive sleepiness associated with obstructive sleep apnea,there was no reduction in nightly nCPAP use with either modafinil or armodafinil. Both modafinil and armodafinil are generally well tolerated; the most commonly observed adverse events occurring more frequently with modafinil and armodafinil (≥ 5%) include headache,nausea,anxiety,and dizziness.
Sodium oxybate. Sodium oxybate (a sodium salt of γ hydroxybutyrate [GHB]) is a CNS depressant approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Sodium oxybate is a liquid agent that is administered immediately before bedtime,with a subsequent dose 2 to 4 hours later. The effect of sodium oxybate on daytime sleepiness was evaluated in a multicenter,double-blind,placebo-controlled study of 228 adults who had narcolepsy with cataplexy. After 8 weeks,patients treated with sodium oxybate 6 g or 9 g demonstrated significant (P < .05) dose-related decreases in subjective excessive sleepiness symptoms,as assessed by the ESS,compared with placebo (P < .001 for each). Significant improvements in objective excessive sleepiness,assessed by the MWT,were seen in patients receiving 4.5-g or 9-g doses but were particularly robust in those receiving 9 g; these patients displayed an increase from baseline of more than 10 minutes—significant versus baseline as well as placebo (P < .001 for each).
In clinical studies of sodium oxybate,most patients (approximately 80%) were treated concurrently with stimulants. Additionally,a recent study of patients with narcolepsy who were treated with sodium oxybate in combination with modafinil suggests that this combination may be more effective at reducing excessive sleepiness symptoms than monotherapy with either agent.
Commonly reported side effects of sodium oxybate (≥ 5% of patients in placebo-controlled studies) include nausea,dizziness,headache,vomiting,somnolence,and urinary incontinence. Because of this agents abuse potential and association with significant CNS adverse events,sodium oxybate is a Schedule III medication when used for its approved indications of cataplexy and excessive sleepiness associated with narcolepsy.","department":"