OTC SLEEP AIDS: OTC SLEEP AIDS Pharmaceutical Care PPRA 522


Normal Sleep Cycle: Normal Sleep Cycle Non-REM Sleep - Stage 1, 2, and (3, 4) Delta. REM Sleep. Sleep latency - initial awake period. REM latency - onset to first REM period (usually 70-90 min). Insomnia 30-35% of population complain of insomnia at some time. Elderly highest prevalence (especially women). Onset is usually before age 40.


Causes: Causes Transient Insomnia - usually is situational, lasting 1-2 days (e.g. acute illness, jet-lag, important meeting, etc) Short-term: - recent loss of a loved one, divorce, loss of a job. Important to deal with effectively in order to avoid progression to chronic insomnia Chronic: - 80% have psychological conflicts Onset usually coincides with peak in life-stress


Causes: Causes Irregular sleep pattern Daytime napping (elderly) Drugs: Stimulants - coffee, cola, decongestants Bronchodilators - theophylline, ß-agonists Diuretics - nocturia Adrenergic inhib. - reserpine, propranolol, pindolol Rebound insomnia - benzodiazep, TCAs, barbs Alcohol - difficulty in maintaining sleep Smoking


Assessment: Assessment Duration of insomnia transient vs short or long term Drug history Depression assessment Difficulty in falling asleep vs maintaining sleep


Other Sleep Disorders: Other Sleep Disorders Sleep walking (somnambulism) and night terrors (pavor nocturnus) occur during delta sleep, usually outgrow. Nightmares - occur during REM sleep (vivid recall) Nocturnal myoclonus - seizure disorder periodic leg movements may cause insomnia


Other Sleep Disorders: Other Sleep Disorders Narcolepsy (tetrad) short attacks of sleep (15 min duration) cataplexy-loss of muscle control sleep paralysis (transition from sleep to awake) hypnagogic hallucinations (frightening dreams) Sleep apnea (central vs obstructive): middle-aged, obese men with short, thick necks - who snore loudly temporary cessation in respiration ---> hypoxic drive stimulates respiration & arousal of patient. OTC sedatives contraindicated.


OTC Sleep Aids: OTC Sleep Aids Diphenhydramine Doxylamine Bendectin [doxylamine + pyridoxine] used for morning sickness withdrawn from the market in 1976 because of suspected (but never proven) teratogen effects. Salicylamide slight sedation at doses of 1.3 Gm no current OTC products


Unapproved agents: Unapproved agents L-tryptophan (Health Food stores) Doses 5-10 Gm may diminish sleep latency and prolong stage 2 sleep (5-HT 100-200 mg similar effect) > 1500 cases of eosinphilia-myalgia syndrome (EMS) including 27 deaths have been reported. FDA recalled all products in 1990.


Unapproved agents: Unapproved agents Removed from market due to toxicity (category III) scopolamine methapyrilene bromides


OTC Sleep Aides: OTC Sleep Aides Melatonin NAT enzyme activated by darkness and converts N-acetylserotonin to melatonin improves sleep latency, but not duration of sleep. optimal dose not well established Biol Psych 1993;33:526-30. Neuropsycho pharm 1990;100:222-36. Clin Pharmacol Therap 1995;57:552-8.


OTC Recommendations: OTC Recommendations OTC product indications: transient episodes only no benefit for patients with sleep maintenance problems Chronic insomnia --------> MD DOC DPH Doxylamine (not FDA approved, but has allowed it to be marketed)


Patient Consultation: Patient Consultation Tolerance to sedation develops rapidly Elderly more susceptible: paradoxical excitation anticholinergic side effects Use during PG is an important ethical delemma


EXAMPLE OTC PRODUCTS:: EXAMPLE OTC PRODUCTS: Tradename Antihistamine Sleepinal diphenhydramine 50 mg Compoz and Sominex diphenydramine 25 and 50 mg Nytol and Sleep-Eze® diphenydramine 25 mg Nytol Maximum Strength doxylamine succinate 25 mg Unisom Nighttime Sleep Aid doxylamine succinate 25 mg


STIMULANTS: STIMULANTS Caffeine (Nodoz®, Vivarin®) 250 mg causes increases plasma conc. of epi. by 100% and norepinephrine by 50% CNS stimulation counteracts drowsiness, fatigue, and reaction time (e.g. typists are able to work faster with fewer errors. chronic caffeine users - may derive little benefit from caffeine (tolerance due to metabolism). GI - stimulates gastric acid secretion (coffee more potent)