Discussion in 'Men's Health Forum' started by Michael Scally MD, Jul 7, 2010.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months
    Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months - Yahoo! Finance

    TEL AVIV, Israel, July 6, 2010 /PRNewswire/ -- Neurim Pharmaceuticals (Neurim Pharmaceuticals - Home Page) confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

    The approval was based primarily on data obtained in the latest SOUNDER-SLEEP Phase IV clinical study, indicating that Circadin was safe and more effective than placebo for at least 3 months. Circadin is now the only sleep medication to be approved for up to 3 months.

    The latest study was a large randomized clinical trial that analyzed more than 600 patients, over 400 of whom where on Circadin treatment for 6 months. The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia. The safety and efficacy data provided in the study support the proposed changes in treatment duration. In particular, the analysis of data from the new study showed that the benefit observed after 3 weeks is maintained for at least 3 months. Moreover, at 3 months, about an extra 10% of responders were seen in the Circadin treated group.

    Circadin (Circadin |Login) is an innovative sleep medication that has been approved by the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH) for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over. The approval is based on clinical studies demonstrating positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning.

    "We are pleased that the EMA recognized the importance of this therapeutic profile and recommended approval of the change in the posology of Circadin from 3 weeks to 3 months of treatment," said ProfessorNava Zisapel, CSO of Neurim Pharmaceuticals, adding, "Importantly, Circadin's efficacy was maintained for at least 3 months and safety was maintained over the entire six months of treatment."

    Dr. Tali Nir, VP Clinical and Regulatory Affairs of Neurim Pharmaceuticals explained that in the case of some hypnotics, concerns of safety and potential dependence issues have led to restrictions in the permitted treatment duration to ultra short periods for 2 to 4 weeks. Adding, "With Circadin there are no safety concerns and no concerns regarding withdrawal or rebound effects, as demonstrated in the study, which would limit the recommendation to treat for the full 3 month short term treatment period."

    About Circadin

    Circadin (Circadin |Login) is the first and only IP-protected prolonged-release melatonin to be approved as an ethical drug by health authorities. Administration of Circadin to patients with primary insomnia improves sleep quality and morning alertness and facilitates sleep onset in patients aged 55 or over. Now it is also the first insomnia treatment approved for up to 13 weeks. Currently Circadin is commercialized in Europeby H.Lundbeck A/S and Nycomed, in Australia by Sigma, in Thailand by DKSH and in Israel by Teva. Circadin is undergoing registration in US, Asia and Latin American markets.

    About Neurim Pharmaceuticals

    Neurim Pharmaceuticals (Neurim Pharmaceuticals - Home Page) is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on drug discovery and development of treatments for age-related disorders, primarily in the central nervous system (CNS).

    For More information:
    Eran Schenker, MD
    Neurim Pharmaceuticals Ltd.
    Tel: +972-3-7684914 Cell: +972-52-6689944
    Last edited: Dec 3, 2010
  2. Bridger

    Bridger Member

    Re: Prolonged-Release Melatonin Approved in the EU for Treatment of Insomnia

    Looks cool. I went to their site to read about possible endocrine sides and didn't see any listed. I thought melatonin could increase prolactin levels?
  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Re: Insomnia

    "Men who complained of chronic insomnia and slept fewer than six hours a night" were "more than four times as likely to die as 'good sleepers,'" Penn State researchers found after conducting a 14-year study. "Add hypertension or diabetes, and men with insomnia were seven times as likely to die as those not suffering from sleep problems," according to the study published in the journal Sleep. Notably, "self-reported chronic insomnia plus lack of sleep among women did not result in more deaths among women," and researchers attribute that finding to "two possibilities: Insomnia among women could be less severe, or the study did not follow women long enough."

    Vgontzas AN; Liao D; Pejovic S; Calhoun S; Karataraki M; Basta M; Fernández-Mendoza J; Bixler EO. Insomnia with short sleep duration and mortality: the Penn State Cohort. SLEEP 2010;33(9):1159-1164.

    Study Objectives: Because insomnia with objective short sleep duration is associated with increased morbidity, we examined the effects of this insomnia subtype on all-cause mortality.

    Design: Longitudinal.

    Setting: Sleep laboratory.

    Participants: 1,741 men and women randomly selected from Central Pennsylvania.

    Measurements: Participants were studied in the sleep laboratory and were followed-up for 14 years (men) and 10 years (women). “Insomnia” was defined by a complaint of insomnia with duration ? 1 year. “Normal sleeping” was defined as absence of insomnia. Polysomnographic sleep dura¬tion was classified into two categories: the “normal sleep duration group” subjects who slept ? 6 h and the “short sleep duration group” subjects who slept < 6 h. We adjusted for age, race, education, body mass index, smoking, alcohol, depression, sleep disordered breathing, and sampling weight.

    Results: The mortality rate was 21% for men and 5% for women. In men, mortality risk was significantly increased in insomniacs who slept less than 6 hours compared to the “normal sleep duration, no insomnia” group, (OR = 4.00, CI 1.14-13.99) after adjusting for diabetes, hypertension, and other confounders. Furthermore, there was a marginally significant trend (P = 0.15) towards higher mortality risk from insomnia and short sleep in patients with diabetes or hypertension (OR = 7.17, 95% CI 1.41-36.62) than in those without these comorbid conditions (OR = 1.45, 95% CI 0.13-16.14). In women, mortality was not associated with insomnia and short sleep duration.

    Conclusions: Insomnia with objective short sleep duration in men is associated with increased mortality, a risk that has been underestimated.

    Attached Files:

    Last edited: Sep 1, 2010
  4. HeadDoc

    HeadDoc Psychologist

    Re: Insomnia

    how would this drug compare to roseram?
  5. zkt

    zkt Member

    Re: Insomnia

    Melatonin might be effective as a time release formulation but doest even compare with a pinch of temazepam under the tongue.
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Sleep and Sex

    THE RECENTLY REVISED INTERNATIONAL CLASSIFICATION OF SLEEP DISORDERS-2ND EDITION (ICSD-2) CONTAINS A SUBSTANTIALLY UPDATED SECTION ON THE parasomnias, which encompass sleep related behaviors, emotions, perceptions, dreaming, and autonomic nervous system events during entry into sleep, within sleep, or during arousals from sleep.” Instinctual behaviors are often released inappropriately, as seen with sleepwalking (locomotion), REM sleep behavior disorder (aggression), sleep related eating disorder (feeding), and confusional arousals (sexual behaviors).

    A classification of sleep related disorders associated with abnormal sexual behaviors and experiences has not been published. There is growing awareness that abnormal sexual behaviors can emerge during sleep, described as “sleepsex,” “atypical sexual behavior during sleep” and “sexsomnia.” The ICSD-2 recognized this phenomenon as a parasomnia classified as a variant of confusional arousals (and sleepwalking). There is an expanding set of sleep disorders and other nocturnal disorders known to be associated with abnormal sexual behaviors, or the misperception of sexual behaviors. The cause of sleepsex can often be identified after clinical and polysomnographic (PSG) evaluations, and can then be effectively treated. The forensic aspects of abnormal sleep related sexual behavior have commanded increasing attention. Also, new data on periodic hypersomnia (Kleine- Levin syndrome), including its range and frequency of abnormal sexual behaviors have recently been published.

    Schenck CH, Arnulf I, Mahowald MW. Sleep and sex: what can go wrong? A review of the literature on sleep related disorders and abnormal sexual behaviors and experiences. Sleep 2007;30(6):683-702. Sleep and Sex: What Can Go Wrong? A Review of the Literature on Sleep Related Disorders and Abnormal Sexual Behaviors and Experiences

    STUDY OBJECTIVES: To formulate the first classification of sleep related disorders and abnormal sexual behaviors and experiences.

    DESIGN: A computerized literature search was conducted, and other sources, such as textbooks, were searched.

    RESULTS: Many categories of sleep related disorders were represented in the classification: parasomnias (confusional arousals/sleepwalking, with or without obstructive sleep apnea; REM sleep behavior disorder); sleep related seizures; Kleine-Levin syndrome (KLS); severe chronic insomnia; restless legs syndrome; narcolepsy; sleep exacerbation of persistent sexual arousal syndrome; sleep related painful erections; sleep related dissociative disorders; nocturnal psychotic disorders; miscellaneous states. Kleine-Levin syndrome (78 cases) and parasomnias (31 cases) were most frequently reported. Parasomnias and sleep related seizures had overlapping and divergent clinical features. Thirty-one cases of parasomnias (25 males; mean age, 32 years) and 7 cases of sleep related seizures (4 males; mean age, 38 years) were identified. A full range of sleep related sexual behaviors with self and/or bed partners or others were reported, including masturbation, sexual vocalizations, fondling, sexual intercourse with climax, sexual assault/rape, ictal sexual hyperarousal, ictal orgasm, and ictal automatism. Adverse physical and/or psychosocial effects from the sleepsex were present in all parasomnia and sleep related seizure cases, but pleasurable effects were reported by 5 bed partners and by 3 patients with sleep related seizures. Forensic consequences were common, occurring in 35.5% (11/31) of parasomnia cases, with most (9/11) involving minors. All parasomnias cases reported amnesia for the sleep-sex, in contrast to 28.6% (2/7) of sleep related seizure cases. Polysomnography (without penile tumescence monitoring), performed in 26 of 31 parasomnia cases, documented sexual moaning from slow wave sleep in 3 cases and sexual intercourse during stage 1 sleep/wakefulness in one case (with sex provoked by the bed partner). Confusional arousals (CAs) were diagnosed as the cause of "sleepsex" ("sexsomnia") in 26 cases (with obstructive sleep apnea [OSA] comorbidity in 4 cases), and sleepwalking in 2 cases, totaling 90.3% (28/31) of cases being NREM sleep parasomnias. REM behavior disorder was the presumed cause in the other 3 cases. Bedtime clonazepam therapy was effective in 90% (9/10) of treated parasomnia cases; nasal continuous positive airway pressure therapy was effective in controlling comorbid OSA and CAs in both treated cases. All five treated patients with sleep related sexual seizures responded to anticonvulsant therapy. The hypersexuality in KLS, which was twice as common in males compared to females, had no reported effective therapy.

    CONCLUSIONS: A broad range of sleep related disorders associated with abnormal sexual behaviors and experiences exists, with major clinical and forensic consequences.
  7. Chris.N

    Chris.N Member

    Re: Sleep and Sex

    That would suck to have sex with someone while you are asleep and then not even remember it in the morning. Especially if you are sharing a bed with a Dude !!!

  8. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Loud Snoring Predicts Metabolic Syndrome
    Medical News: Loud Snoring Predicts Metabolic Syndrome - in Cardiovascular, Metabolic Syndrome from MedPage Today

    Patients with sleep symptoms are at higher risk for developing metabolic syndrome, a prospective study found.

    Difficulty falling asleep, snoring loudly, and unrefreshing sleep were significant predictors of metabolic syndrome (P<0.05). Snoring doubled the risk, while difficulty falling asleep increased the risk by 80%, Wendy Troxel, PhD, of the University of Pittsburgh, and colleagues reported in Sleep.

    Loud snoring also was associated with doubled risks of other metabolic abnormalities, and remained a significant metabolic syndrome predictor after further apnea-hypopnea index (AHI) adjustment, whereas other sleep symptoms were only marginally significant, the researchers noted.

    The study evaluated 2,000 patients enrolled in an ongoing, community-based prospective heart health study. Patients were ages 45 to 74, lived in or around the Pittsburgh metropolitan area, and had no comorbidity limiting life expectancy to less than five years.

    Exclusion criteria included non-black or non-white race, presence of metabolic syndrome or diabetes at baseline, and missing sleep or covariate data at baseline.

    The final sample included 812 patients, with a subset of 294 patients agreeing to undergo further evaluation at home in a follow-up analysis adjusted for AHI.

    The primary outcome was the presence or absence of metabolic syndrome at the three-year follow-up. Waist circumference, fasting glucose, and lipids were measured at baseline and annually for three years.

    Patients were given the Insomnia Sleep Questionnaire and the Multivariable Apnea Prediction Questionnaire to evaluate sleep-disordered breathing and insomnia symptoms. Covariate measures included history of smoking, alcohol consumption, physical activeness, and depressive symptoms.

    At the three year follow-up, 14% of patients developed metabolic syndrome. After adjustment for loud snoring, difficulty falling asleep remained a significant predictor (OR 1.78, 95% CI 1.05 to 3.02), while unrefreshing sleep showed marginal significance (OR 1.56, 95% CI 0.96 to 2.53).

    The significant symptoms also were compared against the AHI. Only loud snoring remained significant as a predictor (OR 3.01, 95% CI 1.39 to 6.55), while difficulty falling asleep was marginal (OR 1.91, 95% CI 0.80 to 4.58).

    Researchers noted the study was limited by self-reported sleep disturbance and lack of sleep duration measures. The AHI analysis was limited by small subsample size and the cross-sectional nature of the AHI assessment.

    Healthcare professionals should look for common sleep symptoms while assessing a patient due to the measured health risks associated with some symptoms, the researchers concluded, adding that future research could look at subjective sleep complaints and psychological factors affecting patients' poor sleep related to cardiovascular morbidity and mortality.

    Troxel WM, Buysse DJ, Matthews KA, et al. Sleep symptoms predict the development of the metabolic syndrome. Sleep 2010;33(12):1633-40.

    BACKGROUND: Sleep complaints are highly prevalent and associated with cardiovascular disease (CVD) morbidity and mortality. This is the first prospective study to report the association between commonly reported sleep symptoms and the development of the metabolic syndrome, a key CVD risk factor.

    METHODS: Participants were from the community-based Heart Strategies Concentrating on Risk Evaluation study. The sample was comprised of 812 participants (36% African American; 67% female) who were free of metabolic syndrome at baseline, had completed a baseline sleep questionnaire, and had metabolic syndrome evaluated 3 years after baseline. Apnea-hypopnea index (AHI) was measured cross-sectionally using a portable monitor in a subset of 290 participants. Logistic regression examined the risk of developing metabolic syndrome and its components according to individual sleep symptoms and insomnia syndrome.

    RESULTS: Specific symptoms of insomnia (difficulty falling asleep [DFA] and "unrefreshing" sleep), but not a syndromal definition of insomnia, were significant predictors of the development of metabolic syndrome. Loud snoring more than doubled the risk of developing the metabolic syndrome and also predicted specific metabolic abnormalities (hyperglycemia and low high-density lipoprotein cholesterol). With further adjustment for AHI or the number of metabolic abnormalities at baseline, loud snoring remained a significant predictor of metabolic syndrome, whereas DFA and unrefreshing sleep were reduced to marginal significance.

    CONCLUSION: Difficulty falling asleep, unrefreshing sleep, and, particularly, loud snoring, predicted the development of metabolic syndrome in community adults. Evaluating sleep symptoms can help identify individuals at risk for developing metabolic syndrome.

    CITATION: Troxel WM; Buysse DJ; Matthews KA; Kip KE; Strollo PJ; Hall M; Drumheller O; Reis SE. Sleep symptoms predict the development of the metabolic syndrome. SLEEP 2010;33(12):1633-1640.

    Attached Files:

  9. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Findings suggest that exposure to room light before bedtime, a common practice in modern society, may inhibit melatonin production and, as a result, alter physiological processes regulated by melatonin signaling. In this report, exposure to electrical light between dusk and bedtime strongly suppresses melatonin levels, leading to an artificially shortened melatonin duration and disruption of the body’s biological signal of night.

    Gooley JJ, Chamberlain K, Smith KA, et al. Exposure to Room Light before Bedtime Suppresses Melatonin Onset and Shortens Melatonin Duration in Humans. J Clin Endocrinol Metab:jc.2010-98. Exposure to Room Light before Bedtime Suppresses Melatonin Onset and Shortens Melatonin Duration in Humans -- Gooley et al., 10.1210/jc.2010-2098 -- Journal of Clinical Endocrinology & Metabolism

    Context: Millions of individuals habitually expose themselves to room light in the hours before bedtime, yet the effects of this behavior on melatonin signaling are not well recognized.

    Objective: We tested the hypothesis that exposure to room light in the late evening suppresses the onset of melatonin synthesis and shortens the duration of melatonin production.

    Design: In a retrospective analysis, we compared daily melatonin profiles in individuals living in room light (<200 lux) vs. dim light (<3 lux).Patients: Healthy volunteers (n = 116, 18-30 yr) were recruited from the general population to participate in one of two studies.

    Setting: Participants lived in a General Clinical Research Center for at least five consecutive days.

    Intervention: Individuals were exposed to room light or dim light in the 8 h preceding bedtime.

    Outcome Measures: Melatonin duration, onset and offset, suppression, and phase angle of entrainment were determined.

    Results: Compared with dim light, exposure to room light before bedtime suppressed melatonin, resulting in a later melatonin onset in 99.0% of individuals and shortening melatonin duration by about 90 min. Also, exposure to room light during the usual hours of sleep suppressed melatonin by greater than 50% in most (85%) trials.

    Conclusions: These findings indicate that room light exerts a profound suppressive effect on melatonin levels and shortens the body's internal representation of night duration. Hence, chronically exposing oneself to electrical lighting in the late evening disrupts melatonin signaling and could therefore potentially impact sleep, thermoregulation, blood pressure, and glucose homeostasis.
  10. hammer12

    hammer12 Junior Member

    Theres studies out there saying insomniacs die earlier or live longer etc but from personal experience insomnia sucks, u feel like crap, your brain feels like its sizzling in a frying pan and i function at a much lower level. Treating insomnia with sleep meds has helped me to function alot better and improved my quality of life. Life would be miserable if u lived along time with crappy sleep. Also everyone is different some people can function on little sleep and some need alot. Its the people who function on little sleep that seem to have no sympathy for insomniacs, maybe those sort of people we need to keep awake for a few days and then they might get the idea of what its like to feel like crap because of no sleep.
  11. dfein

    dfein Junior Member

    Melatonin is an androgen receptor antagonist.
  12. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    I believe you have that incorrect. Melatonin has been found in a small number of animal studies to interfere with the AR cascade. But, there is nothing of note for any clinical effect, yet.
  13. Structure

    Structure Member

    The medication mentioned in the original post, Circadin, looks fantastic. I've used over-the-counter melatonin on-and-off for a over a year now, and can say it definitely helps me get to sleep. However, there are a few peculiarities. This is my experience, YMMV:
    • The OTC melatonin I've used is 3 mg.
    • After I take it, I'm usually sleeping soundly within 20 mins.
    • When I first started taking it, I slept soundly through the whole night.
    • These days, I'll wake up after 3-4 hours of sleep.
    • If I take another melatonin tablet, I'll fall back asleep, and that usually is good until morning.

    I've noticed that Circadin has two key differences from the melatonin that I'm used to. (1) it is a smaller dose, at 2 mg. (2) It is a time-released formulation.

    To me, this makes a lot of sense. I have not looked into how the pineal gland's melatonin release is regulated, but from my own experiences, I would guess that there is some kind of feedback; my guess is that is why I always wake up after 4 hours: my body detects the 3 mg of melatonin that I've taken, and decides not to make as much of its own. When the pill runs out, so does my sleep.

    Has anyone else had this experience?
  14. HeadDoc

    HeadDoc Psychologist

    I have experienced the early wakening from melatonin and the return to sleep on the second dose. Others who I know have experienced the same. Lately, I have done as well on 500mg magnesium.
  15. Structure

    Structure Member

    If you check out Circadin's web site, you'll note that they say it is the first IP protected formulation of time released melatonin. I found it odd that they mentioned that it was patented, so I started investigating the reviews of other time-released melatonin formulations. Twinlab makes a 2mg time-released melatonin product that was well reviewed, so I decided to give it a try.

    So far, I've used it for a little over a week, and it seems to do what it says, which is it releases the 2 mg of melatonin over a time period of six hours. At first, I had trouble getting to sleep, since I'm used to the a non-time-released formulation of 3 mg melatonin, and I'm used to that initial kick of melatonin that typically puts me out fast. However, after a few days, I was getting to sleep faster, and staying asleep longer.

    I still wake up after six hours, though this is better than the 3 to 4 hours I would manage with the other non-time-released melatonin. I'd recommend that anyone that is interested in Circadin should try the Twinlab product.
  16. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Dessert, Laid-Back and Legal

    May 14, 2011

    Remember melatonin? In the 1990s, this over-the-counter dietary supplement was all the rage among frequent fliers, promoted as the miracle cure for jet lag. Now it is back in vogue, this time as a prominent ingredient in at least a half-dozen baked goods that flagrantly mimic the soothing effects of hash brownies — and do so legally. At least for now.

    With names like Lazy Cakes, Kush Cakes and Lulla Pies, these products are sold online and at stores like 7-Eleven, Walgreens, smoke shops and even at the Harvard Square Coop, the university’s student bookstore, for roughly $3 to $4 each. (A bottle of 60 8-milligram melatonin tablets costs about $11.) At some places, the drug-packed desserts can be paid for with food stamps.

    Although the Food and Drug Administration has not approved melatonin as a food additive or deemed it safe, the dessert makers are marketing their products as a harmless way to promote relaxation. And the snacks are increasingly being endorsed by fans on Facebook and Twitter as an antidote to stress and sleep deprivation. (Who needs yoga?) On the Facebook page for Lazy Cakes, one woman who said she has bipolar disorder wrote that the treat “helps a lot with my sleeping and panic attacks I can lay off my Xanax a little.”

    Gabby Bevel, 22, a writer from Norman, Okla., and an insomniac who took Ambien and Lunesta in high school, said in an interview that she slept 13 hours after eating one Lazy Cakes snack recently. “I don’t like the idea of needing something unnatural to help me with anything,” she said. “Really, I think part of the appeal is it does come in a brownie.”

    But these snacks contain roughly 8 milligrams of melatonin per brownie or cookie, so selling them is similar to a parent serving an unsuspecting child applesauce containing a crushed aspirin tablet to make it go down easier. “It’s making it much more difficult for the consumer to recognize that they are taking a drug,” said Dr. Charles A. Czeisler, the chief of the division of sleep medicine at Harvard’s Brigham and Women’s Hospital.

    Nick Collado, a 26-year-old insomniac and the founder of Lulla Pies, argued that the melatonin they contain, while synthetic, is more “natural” than the Ambien he used to take. “I realized there’s got to be more people like me who don’t want to take prescription drugs anymore, who want to take an alternative,” Mr. Collado said.

    But Dr. David S. Seres, the director of medical nutrition at Columbia Medical Center, cautioned that consumers should consult their doctors before trying such products.

    “The promoters of these are appealing to people who think it’s better to do things outside of the medical establishment,” he said, adding that “the desire to help people is an extremely strong motivator, but so is money.” He pointed to a section of the National Institutes of Health’s Web site that lists several drugs, including sedatives like clonazepam and birth control pills, whose efficacy might be altered by melatonin.

    “A hangover effect has been reported” with large doses, said Anna Rouse Dulaney, a toxicologist with the Carolinas Poison Center. But she added, “I don’t want to go on the record saying this drug ‘can’ cause respiratory issues, that should be a ‘may.’ ”

    Lazy Cakes appear harmless, even amusing, with swirly purple packaging; Kush Cakes have a tie-dye-printed wrapper. But they are not to be underestimated.

    Of melatonin, Dr. Seres warned, “If you take it while you’re driving a car, you will find yourself in a ditch.”

    Maybe. Dr. Alfred J. Lewy, a professor of psychiatry at Oregon Health and Science University who has studied melatonin, a neurohormone, estimated that only a third of the population is susceptible to its effects in a supplement.

    And yet Tracy Evans, who owns a bar where musicians perform in Erie, Pa., that has sold hundreds of Lazy Cakes, said she instructs employees to tell partygoers, “I highly recommend you wait to where you’re going to be at the end of the night before eating.”

    Why? “It knocks you out — in a good way, not a bad way,” said Ms. Evans, 34. “For me, it’s not to chill. For me, it’s to get a good night’s sleep.”

    Yet the products, intended for adults only, are being marketed as a novel way to relax in a stressed-out, wired world. Labels on Lazy Cakes and Mary J’s brownies that were bought online urge users to “Take ½ brownie, two times a day.” With tiny type, the labels warn against operating heavy machinery or driving.

    But some medical professionals are concerned that the chocolate taste might encourage indiscriminate gobbling.

    “It’s a colossally bad idea to put melatonin in food,” Dr. Czeisler said. “It should not be permitted by the F.D.A.”

    Technically, it is not. Stephanie Yao, a spokeswoman at the F.D.A., wrote in an e-mail that any item that uses melatonin “as an additive may be subject to regulatory action.”

    That is why the makers of these new baked goods label them “Not for food use.” They want them to be considered dietary supplements, which do not need the F.D.A.’s premarket approval and are not required to be proved safe or effective.

    “It sounds to me like they are trying to claim that the entire brownie is like a tablet, which is, of course, preposterous,” Dr. Czeisler said.

    Tim Barham, the vice president of HBB, the maker of Lazy Cakes, said, “We look at the brownie as a supplement.”

    News reports have classified Lazy Cakes as dietary supplements, but last month, Douglas Karas, an F.D.A. spokesman, said in an e-mail that the agency “has not made a determination on Lazy Cakes’ status as either a food or a dietary supplement.”

    In January last year, the F.D.A. sent a warning letter to Peter Bianchi, the creator of Drank, a purple drink with 2 milligrams of melatonin in each can that went on the market in 2008, spawning several competitors.

    The letter cited safety concerns about melatonin in food, specifically research indicating that melatonin reduced glucose tolerance for people with Type 1 diabetes and that some men using it had reported enlarged breasts. It also warned that women who are pregnant or trying to conceive should avoid melatonin “based on possible hormonal effects.” (Drank’s bottle now say it is a dietary supplement.)

    Dr. Lewy dismissed the idea that harm might lurk in a melatonin-laced brownie. “It really doesn’t have any documented side effects except for making you sleepy at bedtime, which is good,” he said. That said, he would not advise eating Lazy Cakes, partly because he was not sure that their other purportedly sleep-inducing ingredients like valerian root work and partly because food delays rather than hastens the absorption of melatonin.

    Also, Dr. Lewy said, “I don’t need the calories.”
  17. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] Slow Wave Sleep and Steroid Hormones

    testosterone is a crucial hormone in male sexual behavior and reproduction, but also has important beneficial anabolic effects on muscle mass and strength, adiposity and bone density [15]. Nevertheless, the functional role of different sleep stages in steroid secretion is unclear [16], [17]. The hypothesis that SWS suppression changes morning levels of steroids hormones has been addressed directly by Ukraintseva and colleagues [18] in the May 2018 of Sleep Medicine, providing significant novel insights.

    Ukraintseva and colleagues’ recent study [18], shows that selective SWS suppression by 54.2%, without essential changes in total sleep time, decreased morning testosterone concentrations and 17α-hydroxyprogesterone secretion. In contrast, morning cortisol, DHEA, aldosterone concentrations were unchanged. Slow-wave sleep and androgens: selective slow-wave sleep suppression affects testosterone and 17α-hydroxyprogesterone secretion - ScienceDirect

    Their results corroborate cohort study findings which showed that decreased total testosterone levels in men were related to a shorter duration of SWS, a low sleep efficiency and increased nocturnal awakenings and unrelated to their habitual sleep duration [19]. Their study can also explain inconsistencies found in other sleep restriction studies. Therefore, depending on severity of sleep restriction, SWS duration can be decreased, unchanged or even increased leading to contrary results in testosterone levels.

    Their results support the hypothesis that SWS duration is more important in testosterone production than total sleep time, however, the mechanisms remain unclear. …

    Arnal PJ. Slow wave sleep and steroid hormones. Sleep medicine 2019;53:172-3. Slow wave sleep and steroid hormones - ScienceDirect
  18. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Slow-Wave Sleep and Androgens: Selective Slow-Wave Sleep Suppression Affects Testosterone and 17alpha-Hydroxyprogesterone Secretion

    • Slow-wave sleep was suppressed by 54.2% without essential changes in either total night sleep time or sleep efficiency.
    • Slow-wave sleep suppression affected levels of salivary androgens the following morning.
    • Slow-wave sleep suppression did not significantly influence morning cortisol concentrations.
    • The results provide evidence that slow-wave sleep plays a pivotal role in sleep-related secretion and release of androgens.

    OBJECTIVES: Levels of steroid hormones such as androgens and cortisol exhibit circadian variation, and their fluctuations are related to the sleep-wake cycle. Currently, the functional role of different stages of sleep in steroid hormone secretion remains unclear. The present study aims to explore the effect of slow-wave sleep (SWS) suppression on morning levels of cortisol and androgens.

    METHODS: Twelve healthy male volunteers participated in two experimental sessions: a session with selective SWS suppression during night sleep and a session with regular night sleep (control).
    SWS suppression was achieved by stimulation using an acoustic tone. Salivary samples were collected in the morning immediately after awakening and again 40 min later.

    The samples were analysed by liquid chromatography-tandem mass spectrometry for testosterone, androstenedione (Ad), dehydroepiandrosterone (DHEA), 17alpha-hydroxyprogesterone (17-OHP), and cortisol.

    RESULTS: SWS suppression reduced overall SWS duration by 54.2% without significant changes in total sleep time and sleep efficiency. In the session with selective SWS suppression, the average level of morning testosterone was lower than in the control session (p = 0.017).

    Likewise, 17-OHP was lower in the SWS suppression condition (p = 0.011) whereas the ratio of DHEA/Ad was higher (p = 0.025). There were no significant differences between sessions in cortisol, Ad, or DHEA concentrations.

    CONCLUSIONS: The effect of selective SWS suppression on morning levels of testosterone and 17-OHP points to the importance of SWS for the synthesis and secretion of androgens. These results suggest that chronic sleep problems, which lead to reduced SWS, increase the risk for the development of androgen deficiency in the long term.

    Ukraintseva YV, Liaukovich KM, Polishchuk capital A C, et al. Slow-wave sleep and androgens: selective slow-wave sleep suppression affects testosterone and 17alpha-hydroxyprogesterone secretion. Sleep Med 2018;48:117-26. Slow-wave sleep and androgens: selective slow-wave sleep suppression affects testosterone and 17α-hydroxyprogesterone secretion - ScienceDirect