Prescription Sleep Aids Research Articles

A Dietary Supplement Containing Chlorophytum Borivilianum and Velvet Bean Improves Sleep Quality in Men and Women

BackgroundImpaired sleep quality is commonplace within industrialized societies, as evidenced by the increasing number of prescription sleep aids available. Certain herbal preparations have been suggested to provide a natural benefit to sleep; however, limited controlled data are available documenting this benefit. In the present study we tested the effect of an experimental dietary supplement, containing the active ingredients Chlorophytum borivilianum and Velvet bean, on sleep quality using the Pittsburgh Sleep Quality Index (PSQI).MethodsEighteen healthy and active men and women, with evidence of impaired sleep quality, consumed the supplement daily for 28 days. The PSQI was administered before and after the intervention period. As indicators of safety, resting heart rate and blood pressure were measured, and a complete blood count, comprehensive metabolic panel, and lipid panel were determined.ResultsSleep quality was influenced by the supplement, as evidenced by an improvement in every category of the PSQI questionnaire (P < 0.05), with most category scores improving approximately 50% from pre to post intervention. No adverse outcomes were noted with use of the supplement, as indicated by no change in resting heart rate, blood pressure, or any bloodborne parameter.ConclusionsAn investigational dietary supplement containing the active ingredients Chlorophytum borivilianum and Velvet bean improves sleep quality in men and women. Additional placebo controlled trials are needed to corroborate these findings in individuals with self-reported sleeping difficulty.

The Sandman in a Bottle

The Types and Functions of Sleep Aids For millions of Americans who lay awake at night unable to fall asleep, sleeping pills offer a quick and easy way to prevent drowsiness and fatigue the next day. As of 2006, according to an article in Forbes, prescription sleeping pills garnered around $2 billion annually in the United States (Wells 2006). In 2005, 43 million prescriptions were written for prescription sleep aids, and sales of these drugs are pro- jected to rise to $5 billion annually by 2010 (Lazarus 2006). A poll conducted by the National Sleep Foundation found that 10% of working Americans use either a prescription or over-the-counter medication to help them fall asleep (NSF 2008). Yet even as the use of sleep aids rises, scientists are still in the process of figuring out the details of how these drugs work. Today, sleep aids, also known as sedative-hypnotics, fall into three main categories. The first category consists of drugs that act at the GABAA receptor. These include the ben- zodiazepines and the barbiturates. The newest additions to this group are the z-drugs such as Ambien® and Lunesta®, so called because their chemical names all begin with z. The second category of drugs is the antihistamine family of drugs. These drugs are the primary sedative ingredients in medicines like Benadryl®, NyQuil® and other over-the- counter sleep aids. Finally, newest category of sleep aids consists of drugs that act as melatonin receptor agonists. Currently, the only such drug approved for use by the FDA is Rozerem®, although others are undergoing clinical trials. The Neural Circuitry of the Sleep-Wake Cycle Like many animals, humans cope with the daily ris- ing and setting of the sun by sleeping at night and being awake during the day. This cycle involves two competing brain pathways-one involving arousal and the other involv- ing sleep promotion. The arousal and sleep promotion path- ways inhibit one another so that when one becomes strongly activated, the other is rapidly inactivated. This circuit has been called a flip-flop switch, named after the similarly func- tioning circuit known to electrical engineers. This mecha- nism accounts for the suddenness of falling asleep and wak- ing up (Saper et al. 2005). The arousal pathway actually consists of two sepa- rate pathways. The first pathway activates the thalamus, the area of the brain responsible for transmitting information to the cortex. The second pathway activates the cortex and involves a number of different brain regions. One area that is The Sandman in a Bottle THE MIND FALL THE MIND by Matthew Koh particularly relevant to the action of sleep aids is the tubero- mammillary nucleus (TM). The TM contains neurons that respond to the neurotransmitter histamine. From the TM, these neurons project to multiple regions of the brain, includ- ing the basal forebrain, hypothalamus, and amygdala. H1 receptors are located on the postsynaptic cells of these pro- In 2005, 43 million prescriptions were writ- ten for prescription sleep aids, and sales of these drugs are projected to rise to $5 bil- lion annually by 2010. jections and promote wakefulness by stimulating these cells (Barbier and Bradbury 2007). The ventrolateral preoptic nucleus (VLPO) is the main area involved in sleep promotion. The cells in this region contain gamma-amino butyric acid (GABA) and galanin, two inhibitory neurotransmitters. The VLPO proj- ects to all of the major wakefulness-promoting areas of the brain and inhibits these regions (Saper et al. 2005). Central control of all circadian rhythms is provided by the suprachiasmatic nucleus (SCN), a brain region locat- ed directly above the optic chiasm. The SCN receives infor- mation from the retina that it uses to coordinate the body's internal clock with the outside world. Cells in the SCN con- tain receptors for melatonin, which is secreted by the pineal gland in response to signals from the SCN itself (Moore 2007). When activated, melatonin receptors inhibit the SCN. Next, the dorsomedial nucleus of the hypothalamus (DMH) receives input from the SCN and sends output to the VLPO and LHA. The connections to the VLPO are inhibitory whereas those to the LHA are excitatory (Chou et al. 2003). So, when the SCN is inhibited by melatonin, the VLPO becomes less inhibited while the LHA becomes more inhib- ited and sleep is induced. These details of the anatomy involved in sleep regu- lation are necessary for an overall picture of the mechanisms of sleep aids. All of the sleep aids that are mentioned below interact with some step in the sleep-wake neural circuitry. GABAA Receptor Drugs

Drug Makers Find Sept. 11 A Marketing Opportunity

Back to table of contents Previous article Next article Professional NewsFull AccessDrug Makers Find Sept. 11 A Marketing OpportunityJim RosackJim RosackSearch for more papers by this authorPublished Online:1 Mar 2002https://doi.org/10.1176/pn.37.5.0009In the wake of the traumatic events of September 11, pharmaceutical companies drastically increased their expenditures for television advertising of antidepressants and prescription sleep aids. The increased advertising came at the same time as a new head-to-head comparison of the top three SSRI antidepressants raised serious questions about the grounds on which the drugs’ manufacturers rest their marketing assertions (see story on Original article: page 25).According to data compiled by Nielsen Media Research, the independent media research company best known for its television ratings, pharmaceutical commercials increased dramatically in the weeks after September 11.GlaxoSmithKline, maker of Paxil (paroxetine)—generally considered to be the market sales leader among SSRIs—spent a whopping $16.5 million on television ads promoting the drug during the month of October of last year, nearly twice as much as it did during the same month in 2000.Pfizer, the world’s largest pharmaceutical company, spent $5.6 million promoting the benefits of Zoloft (sertraline) in treating posttraumatic stress disorder during October 2001. In October 2000 the company didn’t buy any commercial airtime for its highly competitive product.Depending upon how you look at the data, both GlaxoSmithKline and Pfizer can claim the “best selling” label for its antidepressant. If you consider total dollar sales figures, Zoloft wins the competition; however, if you look at the number of actual prescriptions dispensed during a given time period, Paxil usually edges Zoloft by a thin margin. Paxil usually sells at a slightly lower price, however, so its higher number of prescriptions dispensed actually ring up fewer dollars in the total-sales column.The current number-three selling antidepressant, Eli Lilly and Company’s Prozac (fluoxetine), has been struggling to keep market share after relinquishing the top spot (both in sales dollars and number of prescriptions dispensed) last fall when it lost market exclusivity to generic competition.To bolster sales after the events of September 11, Lilly spent just over $2 million on television ads during October 2001. Comparative figures for Lilly’s promotion of Prozac and Prozac Weekly during October 2000 were not available.Sleep MedicationsCompanies manufacturing medications to promote sleep also increased their advertising spending after September 11. The leading prescription sleeping aid, Ambien (zolpidem), made by G.D. Searle and Co., was heavily advertised in the weeks after the terrorist attacks. The company spent just under $5 million on television ads during October 2001, about three times the $1.7 million it spent during the same month a year earlier.With the four products being advertised to the tune of $28.6 million during the month of October 2001 alone, many critics of the pharmaceutical industry believe that the expensive promotional budgets only lead to higher prices for medications. Whether that is true will continue to be debated, but few doubt the effectiveness of the advertising.Total Drug SalesAccording to NDCHealth, an Atlanta-based independent research firm that tracks prescription data, total sales of the three brand-name SSRIs amounted to $499.6 million during the month of October 2001—an increase of 19 percent over a year earlier. If sales of generic fluoxetine are added to those of the brand, that figure increases to just over $650 million.In only its third month of sales, generic fluoxetine racked up $154 million in October 2001 compared with Prozac’s $71 million. A year earlier, just under $200 million worth of Prozac was sold during the month of October, making it the market sales leader at the time.With the clinical and research community continuing to group all SSRIs into one general category, with each drug being relatively equivalent in efficacy and safety, the pharmaceutical companies are pressed even harder to differentiate their own brand names in the consumer’s minds. Even though that is an expensive proposition, it appears, according to the marketing data, that they are willing to foot the bill. ▪ ISSUES NewArchived

Epidemiology of alcohol and medication as aids to sleep in early adulthood.

In a representative sample of adults 18-45 years of age, this study addressed three questions about the use of sleep aids in the general population: (1) what are the past-year prevalences of the use of alcohol, over-the-counter medication and prescription medication to facilitate sleep? (2) among those who use these substances for sleep problems, what are the patterns of use? and (3) are there social factors, independent of sleep characteristics, that increase the likelihood of alcohol and medication use to aid sleep? The 1996 Detroit Area Survey was a random-digit-dial, computer-assisted survey of a representative sample of 2,181 adults ages 18-45 in the Detroit primary metropolitan statistical area. Eligible household response rate was 86.8%. In the general population, use of alcohol and medication as sleep aids in the past year was found to be fairly common: 13% used alcohol, 18% used medications and 5% used both. The prevalence of any substance use to aid sleep was 26%. The duration of use was short for the majority of users, less than 1 week. However, duration of use was greater for the majority of those using prescription sleep aids. A substantial minority of users report regular use lasting longer than 1 month: 15%, 9%, and 36% for alcohol, OTC medications, and prescription medications, respectively. Both sociodemographic and sleep characteristics were associated with alcohol and medication use to aid sleep. Difficulty falling asleep was the factor most strongly associated with use of substances to improve sleep. Sex, race/ethnicity, work shift, marital status and education were also significantly associated with one or more types of sleep aid use adjusting for difficulty falling asleep.