DRUG INDEX
Insomnia, Sleep Aids, and Stimulant Products
What is insomnia and what causes it?
Insomnia means difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions (e.g., depression , anxiety), environmental changes (e.g., travel, jet lag , or altitude changes), and stressful events. Insomnia can also be caused by faulty sleeping habits such as excessive daytime naps or caffeine consumption.
Insomnia may be classified by how long the symptoms are present. Transient insomnia usually is due to situational changes such as travel and stressful events. It lasts for less than a week or until the stressful event is resolved. Short-term insomnia lasts for 1-3 weeks, and long-term insomnia (chronic insomnia) continues for more than 3 weeks. Chronic insomnia often results from depression or substance abuse. Transient insomnia may progress to short- term insomnia and without adequate treatment, short-term insomnia may become chronic insomnia.
Among the medications and substances that can contribute to insomnia are caffeine and coffee, tobacco, alcohol, decongestants (e.g., pseudoephedrine), diuretics (Lasix/furosemide, Dyazide/hydrochlorothiazide) given at bedtime, antidepressants (e.g., Bupropion , Prozac), appetite suppressants (e.g., Meridia, Fastin), and amphetamines. Insomnia also may be the result of withdrawal from benzodiazepines (e.g., Valium, Librium, Ativan), alcohol, antihistamines, amphetamines, cocaine, and marijuana.
What are non-drug treatments for insomnia?
Appropriate sleep habits are important in the management of insomnia. In some instances, changing sleep habits may correct the problem without the need for medications. Good sleep habits should include: - Regular sleep times;
- A comfortable bed and quiet room at a comfortable temperature;
- Appropriate lighting;
- Regular exercise but not close to bedtime or late in the evening;
- A bedroom that is not used for work or other activities that are not related to sleep;
- Avoidance of stimulants (e.g. caffeine, tobacco), alcohol, and large meals close to bedtime;
- Relaxation techniques such as breathing exercises; and
- Avoidance of naps during the day.
What over-the-counter medicines are there for insomnia?
Self-treatment of insomnia with over-the-counter (OTC) drugs is advisable only for transient or short-term insomnia. OTC sleep aids should only be used for a short period of time in conjunction with changes in sleeping habits. Chronic use of these drugs may result in dependence on the them. This creates a situation in which sleep is not possible unless the drug is used. Chronic insomnia should be evaluated by a physician.
Antihistamines
Diphenhydramine (e.g., Sominex, Nytol) and doxylamine (e.g., Unisom) are the two antihistamines that are currently marketed as OTC sleep aids. Diphenhydramine is the only agent that is considered to be safe and effective by the Food and Drug Administration. The safety and effectiveness of doxylamine has not been evaluated adequately for FDA approval. Other uses for diphenhydramine include allergy , motion sickness , and cough suppression. Scientists believe that diphenhydramine and doxylamine cause sedation by blocking the action of histamine in the brain, but the exact mechanism of action is not known.
If insomnia is associated with pain, there are numerous products containing a combination of an antihistamine and pain reliever. These combination products should not be used if pain is not present because the added pain reliever is not necessary.
Pregnancy and Lactation: The effects of diphenhydramine and doxylamine on the fetus have not been evaluated adequately. Although the likelihood of an adverse effect on the fetus is low, these drugs probably should be avoided during pregnancy. Both agents may decrease lactation (production of milk). Additionally, these drugs are secreted into the breast milk, which could affect the newborn. Therefore, nursing mothers should also avoid both drugs. Children less than 12 years of age should not use doxylamine because its use in this in age group has not been assessed.
Drug Interactions: Diphenhydramine and doxylamine add to the sedative effects of alcohol and other medications that cause drowsiness.
Side Effects: Drowsiness is the most frequent side effect of both diphenhydramine and doxylamine. Therefore, these agents should not be used in situations (e.g., driving) where mental alertness is required. Diphenhydramine and doxylamine also cause constipation , dry mouth, and difficulty urinating. Both drugs may worsen the symptoms of glaucoma , asthma , heart problems, and prostate gland enlargement. People with these conditions should not use OTC sleep aids without consulting a physician.
Both drugs may paradoxically cause excitation, resulting in nervousness and insomnia. This occurs most often in children and the elderly.
Melatonin
Melatonin (e.g., Melatonex) is the only hormone available OTC for insomnia. Melatonin is a hormone that is produced by the pineal gland. Melatonin helps regulate the body's clock or sleep-wake cycle. The secretion of melatonin is increased by darkness and decreased by light. The exact mechanism of how melatonin induces sleep has not been determined. Melatonin also decreases mental alertness and body temperature.
Melatonin is sold as a dietary supplement and is, therefore, not regulated by the Food and Drug Administration (FDA). It is commonly used for jet lag, insomnia, and sleep disturbances related to working the late night shift. Some limited evidence suggests that melatonin may be useful for treating sleep disturbances.
Dosing: There is no established dose or time of administration. Doses of 5 to 10 mg have been evaluated. Individuals should follow the product labeling for dosing and administration.
Pregnancy and Lactation: The use of melatonin during pregnancy or lactation has not been studied adequately. At high doses (more than 300 mg), melatonin may affect contraception ( birth control ) and increase levels of prolactin in the body. Based on past experience with other agents and the possibility of unknown risks to the fetus, melatonin should be avoided during pregnancy or lactation until more information is available.
Children: The use of melatonin in children should be avoided until more information about safety is available.
Drug Interactions: Although melatonin is sold as a dietary supplement, it should be thought of as a drug. It has side effects and may have drug interactions that have not been identified. The level of melatonin that the body produces is increased by certain drugs, such as selective serotonin reuptake inhibitor antidepressants (e.g. Prozac, Zoloft, Paxil) and monoamine oxidase inhibitors (e.g. Parnate, Nardil). The interaction between these antidepressants and melatonin that is used as a sleeping aid has not been assessed.
Side Effects: The most common adverse effect of melatonin is drowsiness. Therefore, tasks that require alertness (e.g,. driving) should be avoided for 4 to 5 hours after taking melatonin. Melatonin also may also cause itching, abnormal heartbeats, and headaches. Long-term side effects of melatonin have not been studied.
Melatonin is either derived from animal sources or synthesized in a laboratory. Melatonin obtained from animal sources has a higher likelihood of contamination, which can cause allergic reactions and viral transmission, than synthetic melatonin.
Melatonin may stimulate the immune system. Therefore, people with severe allergies or other disorders that may be caused by an overactive immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis ) should avoid using melatonin.
What stimulant products are available OTC?
Persons with insomnia often suffer from fatigue as a result of sleep deprivation. Stimulant products are frequently used in an attempt to offset fatigue and other unpleasant side effects that can accompany a lack of sleep. (These products are also used by persons who need to stay awake for longer periods of time than is normal for them, such as school examinations or long distance driving.) However, the use of stimulant products can also cause insomnia, leading to a counterproductive effort to deal with sleep deprivation.
Caffeine
Caffeine (e.g., Nodoz, Caffedrine) is the sole active ingredient in most non-prescription stimulants. It is the only drug approved by the FDA for this purpose. Caffeine is used for improving alertness and for staying awake. Caffeine is a powerful stimulant, but tolerance (the need to use increasing amounts) can be developed. Caffeine also is present in medications for menstrual cramps , headaches, and colds. Additionally, caffeine is found in coffee, tea, and chocolate.
Caffeine increases alertness by stimulating the nerves in the brain and spinal cord. It decreases muscle fatigue by stimulating muscle contraction. Caffeine also increases the heart rate and the force of contraction of the heart. The effect of caffeine varies among individuals and some people are only affected minimally.
Pregnancy and Lactation: Studies have shown that moderate caffeine intake does not cause low birth weights, miscarriages, or premature births. However, there are reports of birth problems in women who consume more than 300 milligrams per day of caffeine. Therefore, daily caffeine intake should probably be limited to less than 300 milligrams during pregnancy.
Caffeine is secreted into breast milk. The concentration of caffeine in breast milk is approximately 1% of the amount in the mother's blood. A lack of sleep and irritation may occur in breastfed infants whose mothers consume more than 600 milligrams of caffeine per day. No adverse effects have been noted in breastfed infants whose mothers consume between 200-336 milligrams per day of caffeine. A mother can limit the amount of caffeine her infant receives by limiting the amount of her caffeine intake and ingesting the caffeine after nursing.
Children: Caffeine is not recommended for children less than 12 years of age.
Drug Interactions: Cimetidine (Tagamet), norfloxacin (Noroxin), ciprofloxacin (Cipro), and the estrogens in oral contraceptives block the break-down and elimination of caffeine from the body. Use of caffeine with these drugs could lead to increased levels of caffeine in the body and, therefore, a higher likelihood of side effects.
Caffeine decreases the absorption of iron tablets. Iron should be administered 1 hour before or 2 hours after the consumption of caffeine.
Caffeine decreases the effects of sedatives, and sedatives decrease the restlessness, alertness, and arousal that is caused by caffeine.
Adverse Effects: The most common adverse effects of caffeine are insomnia, nervousness, excitement, headaches, vomiting, diarrhea , and stomach pain. Caffeine also causes abnormal heartbeats and increases heart rate.
Dependence can occur from the regular use of caffeine. If caffeine intake is stopped suddenly, a withdrawal reaction that consists of fatigue, headaches, anxiety, vomiting, and restlessness may occur. Symptoms of withdrawal start 12-24 hours after the last consumption of caffeine and may last for a week.
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