PrEP use Protects against HIV

Real-World PrEP Use Protects Against HIV

Pam Harrison

July 23, 2014

MELBOURNE, Australia — Pre-exposure prophylaxis (PrEP) protects against HIV in men who have sex with men and transgender women in the real world, even without perfect adherence, open-label extension data show.

“A key finding of this study is that interest and uptake of PrEP is high,” Robert Grant, MD, from the University of California at San Francisco, said at a news conference here at the 20th International AIDS Conference. “We found that 76% of these men and transwomen wanted and started PrEP when given the opportunity to do so.”

“We also discovered that men who have sex with men and transwomen who were at high risk for acquiring HIV were more likely to take up PrEP and were more likely to adhere to it,” Dr. Grant added.

The study results were presented at the meeting and simultaneously published online in the Lancet Infectious Diseases.

The study was open to men and transgender women who previously participated in the randomized iPrEx study and 2 other PrEP trials.

The 72-week open-label extension trial involved 1603 participants not infected with HIV, with an average age of 28 years. In all, 76% opted to start treatment.

Of the patients who chose not to take medication, about half expressed concern about adverse effects. Another quarter said they did not want the inconvenience of taking a pill every day.

At the end of 72 weeks, investigators found that the incidence of HIV was directly related to weekly pill intake. In the original iPrEx study, investigators found that PrEP consisting of emtricitabine and tenofovir reduced the incidence of HIV infection by 44% over a median follow-up period of 1.2 years (N Engl J Med. 2010;363:2587-2599).

Incidence Directly Related to Pill Intake

PrEP use was measured in dried blood spots, a sensitive biomarker of long-term treatment. None of the study participants who took 4 or more tablets a week became infected with HIV.

In contrast, if no drug was detected in dried blood spots, the incidence of HIV was 4.7 per 100 person-years.

If drug concentrations indicated that the user had taken fewer than 2 tablets a week, the incidence of HIV was 2.3 per 100 person-years; for those who took 2 or 3 tablets a week, the incidence was 0.6 per 100 person-years.

In patients with drug concentrations associated with 2 or 3 tablets per week, the risk reduction for HIV infection was 90%, the investigators report.

There was a highly significant difference in HIV incidence between patients who took at least 4 tablets per week and those who did not (< .0001).

“We recommend daily dosing of PrEP because we think that daily use allows for habit formation,” Dr. Grant explained. Daily dosing also creates the highest drug levels, which provides somewhat of a cushion in case people miss a few doses, he added.

“We found that no one, either in the extension study or in the randomized phase of iPrEx, became infected with HIV if their drug levels indicated the use of 4 pills or more per week. This does show some forgiveness for an occasional missed dose, especially if people have previously been taking the drug consistently,” Dr. Grant noted.

Risk-Taking Behavior

After adjustment for sexual behavior, the incidence of HIV was 49% lower in those taking PrEP than those who did not, and 53% lower than in patients in the placebo group of the randomized iPrEx study.

Dr. Grant pointed out that when people were given PrEP and told how safe and effective it is, “we would see the condoms come off and people would have more sexual partners.”

In contrast, extension investigators observed a trend toward safer sexual behavior over time. Research presented here by K. Koester, from the Gladstone Institute of Virology and Immunology in San Francisco, suggests that taking PrEP creates a mindfulness around sexual activity, so people think more about what they want from their sex lives and how best to avoid the adverse consequences of certain sexual practices (abstract TUAC0102).

Some thought that the introduction of PrEP would drive people wild.

Dr. Grant suggested that this new kind of mindfulness could explain the observed trend toward safer sexual practices among PrEP users over time. That said, risky sexual behavior — notably receptive anal sex without condom use — decreased in PrEP users from 33% to 25% over the study period and in non-PrEP users from 27% to 20%. The difference in both groups was significant (< .01).

“The good news about our paper is that people wanted to give PrEP a try when given the chance,” Dr. Grant told Medscape Medical News.

However, PrEP users only took 4 or more tablets per week for about one-third of the full 18-month follow-up, which Dr. Grant said he feels is consistent with human behavior.

“We know that people go on and off PrEP, depending on when they need it,” Dr. Grant told Medscape Medical News. “People get into relationships where they can negotiate safety or they can decide in certain partnerships that they can use condoms. I think the goal here is to provide options.”

These findings reinforce the recent recommendation from the World Health Organization to consider PrEP in men who have sex with men, said Stefano Vella, MD, vice-president of the scientific council of ANRS (Agence Nationale de Recherche sur le Sida) in Paris.

“Some thought that the introduction of PrEP would drive people wild,” Dr. Vella explained. “This study proved that this was not true. So what is being presented here is very important.”

This study “provides still more evidence that gay and bisexual men and transgender women want access to this safe and highly effective form of HIV prevention,” said Jim Pickett, director of prevention advocacy and gay men’s health at the AIDS Foundation of Chicago.

Moving forward, said Pickett, “we must increase awareness of PrEP among all who could benefit from it and overcome critical barriers to PrEP access, including misinformation, lack of provider training, and insufficient coverage from health insurance and other payor programs.”

This study was sponsored by the National Institutes of Health. Gilead Sciences supplied the PrEP drugs used iPrEx OLE. Dr. Grant, Dr. Vella, and Mr. Pickett have disclosed no relevant financial relationships.

20th International AIDS Conference. Abstract TUAC0105LB. Presented July 22, 2014.

Medscape Medical News © 2014  WebMD, LLC

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Cite this article: Real-World PrEP Use Protects Against HIV. Medscape. Jul 23, 2014.


On Wednesday, August 19, 2015 at 6:37:17 AM UTC+1, Kevan Wylie wrote:

 Some news overnight from the US…

 The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner. 

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

 Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Addyi to the FDA’s MedWatch Adverse Event Reporting program at or by calling 1-800-FDA-1088.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Raleigh, N.C. – August 18, 2015 – Sprout Pharmaceuticals, Inc. (Sprout) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of Addyi™ (flibanserin 100 mg) (pronounced add-ee), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States.

The full briefing document from June is too large to attach but provides further information and is available here:


Insomnia – Description

An in-depth report on the causes, diagnosis, treatment, and prevention of insomnia.


What Is Insomnia?

Insomnia can be a short-term or chronic condition, but it always involves problems with falling asleep or staying asleep. Short-term (transient) insomnia can be caused by illness, stress, travel, or environmental factors. Long-term (chronic) insomnia may be due to underlying psychological or physical conditions.

Who Is at Risk?

Anyone can get insomnia, but it is generally more common in women than in men. The elderly are particularly at risk for insomnia.

Diagnosing Insomnia

A doctor will make a diagnosis of insomnia based on information about your sleep patterns. Your doctor may ask:

  • How long does it take you to fall asleep at night?
  • How many times during the night do you wake up?
  • Do you experience daytime fatigue?
  • Do you have a medical condition that may interfere with sleep?
  • What medications do you take (including prescription drugs, over the counter drugs, and herbs or supplements?)
  • Do you drink alcohol or smoke?

Your doctor may also ask you to keep a sleep diary to record specific sleep-related information.

Treating Insomnia

Sleep hygiene is an important first step for controlling insomnia. These simple self-help measures include establishing a regular bedtime routine, regulating mealtimes and fluid consumption, and limiting caffeine consumption.

Behavioral therapy methods include various approaches for training new sleep behaviors and helping patients relax and sleep well. Behavioral therapy can help treat insomnia in people of all ages.

If self-help or behavioral therapy do not solve the problem, a doctor may prescribe medications for use on a short-term basis. Non-benzodiazepine sedative hypnotics are usually the preferred type of drugs. They include zolpidem (Ambien, generic), zaleplon (Sonata, generic), eszopiclone (Lunesta), and ramelteon (Rozerem). These drugs can cause side effects, and it is important that your doctor explains the risks of these drugs and the precautions you need to take.

Drug Approval

In 2011 the Food and Drug Administration (FDA) approved Intermezzo, a lower-dose form of zolpidem, for treating middle-of-the-night awakening. Patients who wake up abruptly in the middle of the night and then have trouble falling back asleep can dissolve the tablet under the tongue. People who use Intermezzo require at least 4 hours for sleep after taking the tablet. Higher-dose zolpidem pills (Ambien, generic) are used when first going to sleep and require at least 7 – 8 full hours of sleep.


Insomnia comes from the Latin words for “no sleep.” Insomnia is characterized by:

  • Difficulty falling asleep
  • Difficulty staying asleep
  • Waking up too early
  • Poor quality (“non-restorative”) sleep

Insomnia may be primary or secondary:

  • Primary insomnia means that the inability to sleep is not caused by other health
  • Secondary insomnia is due to other health conditions that interfere with sleep. It is also called “comorbid insomnia.”

Duration of Insomnia

Insomnia is often categorized by how long it lasts:

  • Transient insomnia lasts for a few days.
  • Short-term insomnia lasts for no more than 3 weeks.
  • Chronic insomnia occurs at least 3 nights per week for 1 month or

Related Disorders

Insomnia may also be defined in terms of inability to sleep at conventional times. The following examples are referred to as circadian rhythm disorders:

  • Delayed Sleep-Phase Syndrome. Delayed sleep-phase syndrome is the term for a circadian clock that runs late but reliably. People who have this condition (usually adolescents) fall asleep very late at night or in early morning hours, and have difficulty waking up in the morning.
  • Advanced Sleep-Phase Syndrome. This syndrome tends to develop in older people. It produces excessive sleepiness in the morning and undesired awakening early (3 – 5 a.m.) in the morning.

Healthy Sleep

In sleep studies, subjects spend about one-third of their time asleep, suggesting that most people need about 8 hours of sleep each day. Individual adults differ in the amount of sleep they need to feel well rested, however. (Infants may sleep as many as 16 hours a day.)

The daily cycle of life, which includes sleeping and waking, is called a circadian (meaning “about a day”) rhythm, commonly referred to as the biologic clock. Hundreds of bodily functions follow biologic clocks, but sleeping and waking comprise the most prominent circadian rhythm. The sleeping and waking cycle is about 24 hours. It usually takes the following daily patterns:

Humans are designed for daytime activity and night time rest.

Additionally, there is a natural peak in sleepiness at mid-day, the traditional siesta time.

In addition, daily rhythms intermesh with other factors that may interfere or change individual patterns:

The monthly menstrual cycle in women can shift the pattern.

Light signals coming through the eyes reset the circadian cycles each day, so changes in season or various exposures to light and dark can unsettle the pattern. Sunlight is an important regulator of circadian rhythms. People who are blind commonly suffer from trouble sleeping and other circadian rhythm disruptions.

The Response in the Brain to Light Signals

The response to light signals in the brain is an important key factor in sleep:

Light signals travel to a tiny cluster of nerves in the hypothalamus in the center of the brain, the body’s master clock, which is called the supra chiasmatic nucleus (SCN).

This nerve cluster takes its name from its location, which is just above (supra) the optic chiasm, a major junction for nerves transmitting information about light from the eyes.

The approach of dusk each day prompts the SCN to signal the nearby pineal gland (so named because it resembles a pinecone) to produce the hormone melatonin.

Melatonin is thought to act as the body’s clock-setting hormone. The longer a person is in darkness the longer the duration of melatonin secretion. Secretion can be diminished by staying in bright light. Melatonin also appears to trigger the need to sleep.

Sleep Cycles

Sleep consists of two distinct states that alternate in cycles and reflect differing levels of brain nerve cell activity:

Non-Rapid Eye Movement Sleep (NonREM). NonREM sleep is also termed quiet sleep. NonREM is further subdivided into three stages of progression:

  • Stage 1 (light sleep)
  • Stage 2 (so-called true sleep)
  • Stage 3 to 4 (deep “slow-wave” or delta sleep)

With each descending stage, awakening becomes more difficult. It is not known what governs NonREM sleep in the brain. A balance between certain hormones, particularly growth and stress hormones, may be important for deep sleep.

Rapid Eye-Movement Sleep (REM). REM sleep is termed active sleep. Most vivid dreams occur in REM sleep. In REM sleep, brain activity is comparable to that in waking, but the muscles are virtually immobilized, which prevents people from acting out their dreams. In fact, except for vital organs like lungs and heart, the only muscles not immobilized during REM are the eye muscles. REM sleep may be critical for learning and for day-to-day mood regulation. When people are sleep-deprived, their brains must work harder than when they are well rested.

The REM/NREM Cycle. The cycle between quiet (nonREM) and active (REM) sleep generally follows this pattern:

After about 90 minutes of nonREM sleep, eyes move rapidly behind closed lids, giving rise to REM sleep.

As sleep progresses the nonREM/REM cycle repeats.

With each cycle, nonREM sleep becomes progressively lighter, and REM sleep becomes progressively longer, lasting from a few minutes early in sleep to perhaps an hour at the end of the sleep episode.

Causes of Short-Term and Transient Insomnia

A reaction to change or stress is a common cause of short-term and transient insomnia. This condition is sometimes referred to as adjustment sleep disorder.

The trigger could be a major or traumatic event such as:

  • An acute illness
  • Injury or surgery
  • The loss of a loved one
  • Job loss

Temporary insomnia can also develop after a relatively minor event, including:

  • Extremes in weather
  • An exam
  • Traveling, particularly across time zones
  • Trouble at work

In most cases, normal sleep almost always returns when the condition resolves, the individual recovers from the event, or the person becomes used to the new situation. Treatment is needed if sleepiness interferes with functioning or if it continues for more than a few weeks. Individual responses to stress vary and some people may not experience insomnia at all, even during very stressful situations while others may suffer from insomnia in response to very mild stressors.

Female Hormonal Fluctuations

Fluctuations in female hormones play a major role in insomnia in women over their lifetimes. This insomnia is usually temporary.

During Menstruation. Progesterone promotes sleep, and levels of this hormone plunge during menstruation, causing insomnia. (When they rise during ovulation, women may become sleepier than usual.)

During Pregnancy. The effects of changes in progesterone levels in the first and last trimester can disrupt normal sleep patterns.

Menopause. Insomnia can be a major problem during the transition to menopause (perimenopause), when hormones are fluctuating intensely. Insomnia during this period may be due to several different factors. In some women, hot flashes, sweating, and a sense of anxiety can disrupt sleep and cause sudden and frequent awakening. In many cases, the insomnia is temporary. Treating hot flashes may help resolve chronic insomnia.

Jet Lag

Air travel across time zones often causes insomnia. After long plane trips, a day of adjustment is usually needed for each time zone crossed. Traveling from the east to an earlier time zone in the west seems to be less disruptive than traveling to a later time zone in the east because it is easier to lengthen a circadian phase than to shorten it.

Effect of Light and Other Environmental Disruptions

Light, noise, and uncomfortable temperatures can cause sleeplessness. Depending on the time of day, too much or too little light can disrupt sleep.

Excessive Light at Night. A person’s biologic circadian clock is triggered by sunlight, and very bright artificial light maintains wakefulness.

Insufficient Light during the Day. Insufficient exposure to light during the day, as occurs in some disabled elderly patients who rarely venture outside, may also be linked with sleep disturbances.

Other Causes of Short-Term or Transient Insomnia

Caffeine. Caffeine is a stimulant, which can interfere with falling asleep.

Nicotine. Nicotine is also a stimulant, but quitting smoking can lead to transient insomnia.

Partner’s Sleep Habits. A partner’s sleep habits, including snoring, can impair one’s own sleep.

Medications. Insomnia is a side effect of many common medications, including over-the-counter preparations that contain caffeine or decongestants. If you suspect your medications are causing you to lose sleep, check with your doctor or pharmacist.

Causes of Chronic Insomnia

Sleep problems seem to run in families. Many people with insomnia have a family history of insomnia, with the mother being the most commonly affected family member. Still, because so many factors are involved in insomnia, a genetic component is difficult to define.

Anxiety, Depression, and Other Mental Health Disorders

Many cases of chronic insomnia cases have an emotional or psychological basis. The disorders that most often cause insomnia are:

  • Anxiety
  • Depression
  • Bipolar disorder
  • Attention-deficit hyperactivity disorder
  • Post-traumatic stress disorder

Insomnia may also cause emotional and mental health problems, such as depression and anxirty. It is often unclear which condition has triggered the other, or if the two conditions, in fact, have a common source.

Psychophysiologic Insomnia

In many cases, it is unclear if chronic insomnia is a symptom of some physical or psychological condition or if it is a primary disorder of its own. In most instances, a mix of psychological and physical conditions causes the insomnia.

Psychophysiologic insomnia occurs when:

Transient insomnia disrupts the person’s circadian rhythm.

The patient begins to associate the bed not with rest and relaxation but with a struggle to sleep. A pattern of sleep failure emerges.

Over time, this event repeats, and bedtime becomes a source of anxiety. Once in bed, the patient broods over the inability to sleep, the consequences of sleep loss, and the lack of mental control. All attempts to sleep fail.

Eventually excessive worry about sleep loss becomes persistent and provides an automatic nightly trigger for anxiety and arousal. Unsuccessful attempts to control thoughts, images, and emotions only worsen the situation. After such a cycle is established, insomnia becomes a self-fulfilling prophecy that can persist indefinitely.

Medical Conditions and Their Treatments

Among the many medical problems that can cause chronic insomnia are allergies, benign prostatic hyperplasia (BPH), arthritis, gastroesophageal reflux disease (GERD), asthma, chronic obstructive pulmonary disorder (COPD), rheumatologic conditions, Alzheimer’s disease, Parkinson’s disease, hyperthyroidism, epilepsy, and fibromyalgia. Other types of sleep disorders, such as restless legs syndrome and sleep apnea, can cause insomnia. Many patients with chronic pain also sleep poorly.

Medications. Among the many medications that can cause insomnia are antidepressants (fluoxetine, bupropion), theophylline, lamotrigine, felbamate, beta-blockers, and beta-agonists.

Substance Abuse

Substance abuse can cause chronic insomnia.  This is especially true for alcohol, cocaine, and sedatives. One or two alcoholic drinks may help reduce stress and initiate sleep. However, excessive alcohol use tends to fragment sleep and cause wakefulness a few hours later. It also increases the risk for other sleep disorders, including sleep apnea and restless legs. Alcoholics often suffer insomnia during withdrawal and, in some cases, for several years during recovery.

Risk Factors

More than a quarter of all Americans experience transient insomnia at some point during a year, and nearly 10% have chronic insomnia.


Overall, insomnia is more common in women than men, although men are not immune from insomnia. Sleep efficiency deteriorates equally in men and women as they get older.

Hormonal fluctuations that occur during menstruation, pregnancy, and menopause put women at higher risk of insomnia. Women are also more likely than men to suffer from anxiety and depressive disorders, which can cause insomnia.


Insomnia is more common in older people than younger people. As people grow older, sleep patterns change. Older adults tend to wake up frequently during the night, wake up earlier, and report waking up feeling unrefreshed.

Older people are more likely than younger people to have medical conditions that cause pain or nighttime distress. These conditions include arthritis, gastrointestinal distress, frequent urination, lung disease, and heart conditions. Neurologic conditions, such as Parkinson’s and Alzheimer’s, can also affect sleep patterns. Consequences of poor sleep in the elderly include increased risk of falls.

Shift Work

Shift workers are at considerable risk for insomnia. Workers over age 50 and those whose shifts are always changing are particularly susceptible to insomnia, although night-shift workers also have a high rate of sleeplessness. Night-shift workers are at risk for falling asleep on the job at least once a week, implying that their internal clocks do not adjust to unusual work times. (They are also at much higher risk than other workers for automobile accidents due to their drowsiness and may also have a higher risk for health problems in general.)


Insomnia itself is not life threatening, but it can increase the risk of accidents, psychiatric problems, and certain medical conditions, affect school and work performance, and significantly interfere with quality of life. Lack of sleep can cause weight gain and obesity.

Increased Risk of Accidents

Sleepiness increases the risk for motor vehicle accidents. Studies indicate that drowsy driving is as risky as drunk driving.

Quality of Life

Surveys show that people with severe insomnia have a quality of life that is almost as poor as those who have chronic medical conditions, such as heart failure. Daytime sleepiness can lead to decreased energy, irritability, mistakes at work and school, and poorer relationships.

Thinking and Performance

Insomnia makes it harder to concentrate and perform tasks. Deep sleep deprivation impairs the brain’s ability to process information and reduces concentration.

Mood Disorders

Although stress and depression are major causes of insomnia, insomnia may also increase the activity of the hormones and pathways in the brain that are associated with mental health problems. Chronic insomnia may increase the risk of developing depression and anxiety.

Even modest alterations in waking and sleeping patterns can have significant effects on a person’s mood. In both children and adults, the combination of insomnia and daytime sleepiness can produce more severe depression than either condition alone.


Having a doctor diagnose sleep disturbance and its cause is the most important step in restoring healthy sleep. However, there is little agreement, even among doctors, on the best methods for effectively assessing a patient’s insomnia.

Sleep Questionnaires

A number of questionnaires are available for determining whether a patient has insomnia or other sleep disorders. For example, the doctor may ask:

  • How would you describe your sleep problem?
  • How long have you had the sleep problem?
  • How long does it take to fall asleep?
  • How many times a week does it occur?
  • How restful is sleep?
  • Do you have trouble falling asleep or do you wake up too early?
  • What is the sleep environment like? (Noisy? Not dark enough?)
  • How does insomnia affect daytime functioning?
  • What medications do you take? (Include herbs and over-the-counter or prescription drugs.)
  • Are you taking or withdrawing from stimulants, such as coffee or tobacco?
  • How much alcohol is consumed per day?
  • What stresses or emotional factors may be present?
  • Have you experienced any significant life changes?
  • Do you snore or gasp during sleep (an indication of sleep apnea)?
  • Do you have leg problems (cramps, twitching, crawling feelings)?
  • If there is a bed partner? Is this person’s behavior distressing or disturbing?
  • Are you a shift worker?

Sleep Diary. If the patient cannot answer these questions, keeping a sleep diary is a helpful diagnostic tool. Every day for 2 weeks, the patient should record all sleep-related information (including responses to questions listed above). Other information should include the time the patient went to bed, time spent falling asleep, number of nocturnal awakenings, and rising time. A bed partner’s observations of the patient’s sleep behavior can also help.

Measuring Sleepiness

Actigraphy. Actigraphy uses a portable device with a sensor to monitor a patient’s movement. Actigraphy may be used in some situations to help give a doctor a better picture of the patient’s sleep pattern. It cannot, however, determine the severity of sleep problems. Most patients with insomnia are diagnosed and treated without this test. However, actigraphy may help identify insomnia in some patients.

Sleep Disorders Centers

If unexplained insomnia persists after treatment or there is evidence of a primary sleep disorder, such as sleep apnea or narcolepsy, the doctor may recommend a sleep specialist or a sleep disorders center. Centers are accredited by the American Academy of Sleep Medicine. Patients should investigate centers carefully, to be sure that they offer full sleep studies. [For more information, see In-Depth Report #65: Sleep apnea and #98: Narcolepsy.]

Among the signs that may indicate a need for a sleep disorders center are:

  • Insomnia due to psychologic disorders
  • Sleeping problems due to substance abuse
  • Snoring and sudden awakening with gasping for breath (possible sleep apnea)
  • Severe restless legs syndrome
  • Persistent daytime sleepiness
  • Sudden episodes of falling asleep during the day (possible narcolepsy)

At most sleep disorders centers, patients undergo an in-depth analysis, usually supervised by a multidisciplinary team of consultants who can provide both physical and psychiatric evaluations.


The American Academy of Sleep Medicine (AASM) recommends a number of behavioral methods and prescription medications as the main treatments for insomnia. According to the AASM, these treatment options can improve both quality and quantity of sleep for people with insomnia.

Doctors agree that behavioral therapies should be the first-line treatment for insomnia. For children in particular, medications should rarely be used as initial treatment.

Sleep Hygiene Tips

Proper sleep hygiene should accompany any behavioral method. The term sleep hygiene is used to describe simple behaviors that may help everyone improve their sleep. These include:

Establish a regular time for going to bed and getting up in the morning. Stick to this schedule even on weekends and during vacations.

Use the bed for sleep and sexual relations only, not for reading, watching television, or working. Excessive time in bed disrupts sleep.

Avoid naps, especially in the evening.

Exercise before dinner. A low point in energy occurs a few hours after exercise; sleep will then come more easily. Exercising close to bedtime, however, may increase alertness.

Taking a hot bath about 1.5 – 2 hours before bedtime may help you fall asleep more easily. (Taking a bath just before bed may increase alertness.)

Do something quiet and relaxing in the 30 minutes before bedtime. Reading, meditating, or a leisurely walk are all appropriate activities.

Keep the bedroom relatively cool and well ventilated.

Do not look at the clock. Obsessing over time will just make it more difficult to sleep.

Eat light meals, and schedule dinner 4 – 5 hours before bedtime. A light snack before bedtime can help sleep, but a large meal may have the opposite effect.

Spend at least a half hour in daylight every day. The best time is early in the day.

Avoid fluids just before bedtime so that sleep is not disturbed by the need to urinate.

Avoid stimulants such as caffeine or nicotine in the hours before sleep.

Avoid alcohol in the hours before bedtime. While alcohol may help you fall asleep quickly, it can cause you to awaken in the middle of the night.

If still awake after 15 – 20 minutes, go into another room, read or do a quiet activity using dim lighting until feeling very sleepy. (Don’t watch television or use bright lights.)

If distracted by a sleeping bed partner, moving to the couch or a spare bed for a couple of nights might be helpful.

If a specific worry is keeping you awake, thinking of the problem in terms of images rather than in words may help you to fall asleep more quickly and to wake up with less anxiety.

Behavioral Therapy

Various approaches are available to help people learn how to relax and sleep well. Behavioral techniques can actually cure chronic insomnia in many cases, and studies report that they help nearly all patients with primary chronic insomnia. The benefits of psychological and behavioral therapy in managing insomnia are long lasting.

Although medications can help people with insomnia to sleep, they cannot cure the condition. In addition, behavioral methods act faster. Behavioral methods work for all age groups, including children and elderly patients.

Behavioral methods include:

  • Stimulus control
  • Cognitive behavioral therapy
  • Relaxation training and biofeedback
  • Sleep restriction

All behavioral approaches have the same basic goals:

  • To reduce the time it takes to go to sleep to below 30 minutes
  • To reduce wake-up periods during the night

Studies report that the majority of patients who are treated with non-drug methods experience improved sleep. Furthermore, most of those who have been taking drugs are able to stop or reduce their use.

Stimulus Control. Stimulus control is considered the standard treatment for primary chronic insomnia and may also be helpful for some patients with secondary insomnia. The primary goal of stimulus control is to regain the idea that the bed is for sleeping. It involves the following:

  • Go to bed only when ready to sleep or for sex.
  • If unable to sleep within 15 – 20 minutes, get up and go into another room. (People who find it physically difficult to get out of bed should sit up and do something relatively arousing, like reading a book.)
  • Maintain a regular wake-up time no matter how few hours you actually sleep.
  • Avoid naps.

Cognitive-Behavioral Therapy. Cognitive behavioral therapy (CBT) is a form of therapy that emphasizes observing and changing negative thoughts about sleep such as, “I’ll never fall asleep.” It uses actions intended to change behavior. The goal is to change or correct misconceptions about the ability to fall and stay asleep. Emphasis is on reinforcing the need for 7 – 8 hours of sleep each night and addressing the anxiety that patients with insomnia often develop around sleep. Many studies have shown it to work as well or better than drugs. According to several studies, adding medication to CBT does not provide additional benefit.

Relaxation Training and Biofeedback. Relaxation training includes breathing and guided imagery techniques. Progressive muscle relaxation is another technique for inducing sleep that works well for many people. It takes about 10 minutes to perform:

Focus on one specific muscle group at a time. Most people start with the muscles in one foot. Inhale and tense the foot muscles for about 8 seconds. (Do this gently. It is not intended to cause severe pain or muscle contractions.)

Relax the foot, and let it become loose and limp. Stay relaxed for 15 seconds, then repeat with the other foot.

Move up to the next muscle group and repeat the sequence, doing one side of the body at a time. Move progressively from each foot and leg up through the abdomen and chest, to each hand and arm, then to the neck, shoulders, and face.

Biofeedback may be combined with relaxation techniques. Biofeedback involves being monitored with an electroencephalogram (EEG), a device that measures brain waves. Patients are given feedback to recognize certain states of tension or sleep stages so that they can either avoid or repeat them voluntarily.

Paradoxical Intention and Sleep Restriction Therapies. Paradoxical intention is a type of cognitive technique that aims to conquer anxiety about insomnia by forcing the patient to stay awake. Not trying to fall asleep may help relieve performance anxiety associated with sleep.

Sleep restriction therapy is similar to paradoxical intention. It involves limiting the time spent in bed to the number of hours that are typically actually spent asleep. Eventually the sleep loss helps some people fall asleep faster and spend more time asleep. As sleep improves, the hours spent in bed are increased.

Drug Therapy

In general, the following considerations are important regarding the use of medications for the treatment of insomnia:

Underlying mental health problems, such as anxiety or depression, should be addressed first.

Behavioral or psychologic techniques can actually correct insomnia, while prolonged use of sleeping pills can only produce temporary improvement.

Non-benzodiazepine sedative hypnotics may be better tolerated than benzodiazepines and have less risk of dependency. However, these drugs may cause hazardous or strange behaviors, such as driving, making phone calls, or eating while asleep. If you need to take one of these prescription drugs, start with as low a dose as possible.

For adults over age 60 years, studies suggest that the risks of sedative hypnotics may far outweigh their benefits. Sleep medications increase the risks for falls, depression, and memory loss in older patients. Elderly patients should generally start sleep medications at lower doses than younger patients.

As a general rule, do not take either prescription nor non-prescription sleeping pills on consecutive days or for more than 2 – 4 days a week.

If insomnia is still a problem after stopping the drug and continuing with good sleep hygiene, this pattern can be repeated again, but for only up to 4 weeks.

Medication should be withdrawn gradually, and the patient should be aware of the possibility of rebound insomnia after stopping medication. Rebound insomnia is the the return of insomnia after medication is discontinued. It usually lasts for several days and can be more severe than the original insomnia.

Alcohol intensifies the side effects of all sleeping medication and should be avoided.

If chronic insomnia is accompanied by depression or anxiety, treating these problems first may be the best approach.


Many older Americans use some form of sleep aid pill, including prescription or over-the-counter drugs. Over-the-counter (nonprescription) medications make use of the drowsiness caused by some common medications. Prescription drugs used specifically for improving sleeping are called sedative hypnotics. These drugs include benzodiazepines and non-benzodiazepines.

Sedative hypnotics carry risks for dependence, tolerance, and rebound insomnia:

Dependence means relying on a drug for falling asleep and having difficulty falling asleep or achieving restful sleep without it.

Tolerance is being unable to fall asleep using the original dose and needing to take progressively higher doses of medication.

Rebound insomnia can occur after a patient stops taking the drug. It typically causes 1 – 2 nights of sleep disturbance, daytime sleepiness, and anxiety. In some cases, patients may experience a temporary worsening of long-term insomnia.

Common Non-Prescription Sleep Medications

Brands with Antihistamines. Many over-the-counter sleeping medications use antihistamines, which cause drowsiness. Diphenhydramine (Benadryl, generic) is the most common antihistamine used in non-prescription sleep aids.

Some drugs marketed as sleep aids contain diphenhydramine alone, while others contain combinations of diphenhydramine with pain relievers (such as Tylenol PM and its generic forms). Doxylamine (Unison, generic) is another antihistamine used in sleep medications. Certain antihistamines indicated only for allergies, such as chlorpheniramine (Chlor-Trimeton, generic) or hydroxyzine (Atarax, Vistaril, generic) may also be used as mild sleep-inducers.

Unfortunately, most of these drugs leave patients feeling drowsy the next day and may not be very effective in providing restful sleep. Side effects include:

  • Daytime sleepiness
  • Cognitive impairment
  • Dizziness
  • Drunken movements
  • Blurred vision
  • Dry mouth and throat

In general, people with angina, heart arrhythmias, glaucoma, or problems urinating should avoid these drugs. They should not be used at the same time as medications that prevent nausea or motion sickness. Patients with chronic lung disease should also avoid some non-prescription sleeping aids, such as those containing doxylamine.

Common Pain Relievers. When sleeplessness is caused by minor pain, simply taking acetaminophen (Tylenol, generic) or a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Advil, Motrin, generic), can be very helpful without causing any daytime sleepiness. The extra “P.M.” antihistamine found in combination products is simply an extra, needless chemical in these situations.

Non-Benzodiazepine Hypnotics

Newer short-acting non-benzodiazepines can induce sleep with fewer side effects than benzodiazepines. Both benzodiazepine and non-benzodiazepine sedative hypnotics act on gamma-aminobutyric acid (GABA) receptor sites in the brain, but non-benzodiazepines are more specific in the subunits they target. These drugs are now the preferred sedative hypnotic drugs for the treatment of insomnia. In general, non-benzodiazepine hypnotics are recommended for short-term use (7 – 10 days), and treatment should not exceed 4 weeks.

Brands. Non-benzodiazepine hypnotics currently approved in the United States are:

  • Zolpidem (Ambien, Ambien CR, generic) is one of the most commonly prescribed drugs for insomnia. It lasts longer than zaleplon. Patients should not take it unless they plan on getting at least 7 – 8 hours of sleep. A lower-dose, sublingual (under-the-tongue) formulation of zolpidem (Intermezzo) is approved for patients who wake up abruptly in the middle of the night and have trouble falling back asleep. Patients take it as needed when they awaken in the night (but must be able to get at least 4 hours of sleep after taking.
  • Zaleplon (Sonata, generic) is the shortest-acting hypnotic available. Because it is rapidly eliminated from the body it may be best for people who have difficulty falling asleep, not those who wake up often throughout the night. The drug takes effect within 30 minutes and may be taken at bedtime or later as long as the patient can sleep for at least 4 hours.
  • Eszopiclone (Lunesta) may help improve both sleep maintenance and daytime alertness. Eszopiclone is related to zopiclone (Imovane), which has been used for many years in Europe. Unlike other sleep medications, eszopiclone was the first sleep medication approved to be taken on a long-term basis.
  • Ramelteon (Rozerem) is the newest type of sedative hypnotic but it is not technically a non-benzodiazepine hypnotic. Unlike other prescription sleep drugs, which target GABA receptors, ramelteon works by targeting melatonin receptors. Ramelteon is not habit forming and is the first sleep drug not designated as a controlled substance.

Side Effects. All of these drugs have fewer morning side effects than the benzodiazepines, including morning sedation and memory loss (although they can occur to some degree). When patients first start taking any of these drugs, they should use caution during morning activities until they are sure how the drug affects them.

General side effects may include:

  • Drowsiness
  • Dizziness
  • Fatigue
  • Headache
  • Unpleasant taste
  • Diarrhea

All non-benzodiazepine drugs carry labels warning that that these drugs can cause sleep-related behavior, including driving, making phone calls, and preparing and eating food while asleep. (Most cases of sleepwalking and sleep driving likely occur when patients use zolpidem along with alcohol or other drugs or take more than the recommended dose.) In addition, severe allergic reactions (anaphylaxis) and facial swelling (angioedema) can occur even the first time one of these drugs is taken.

Anyone who receives a prescription for these medicines will get a patient medication guide explaining the risks of the drugs and the precautions to take. Talk to your doctor if you have any questions concerning these drugs or their potential side effects.

Patients should carefully read the information labels for all drugs and follow the directions. Some sleeping pills take 30 – 60 minutes to take effect, while others (such as zolpidem) act quickly. For zolpidem, patients should:

  • Take zolpidem immediately before going to sleep
  • Take zolpidem only when able to get a full night’s sleep (7 – 8 hours)
  • Not drink alcohol the same evening
  • Not take more than the prescribed dose
  • Use caution in the morning when getting out of bed, driving, or operating heavy machinery

Interactions. As with any hypnotics, alcohol increases the sedative effects of these drugs. These hypnotics also interact with other drugs, including rifampin, ketoconazole, erythromycin, and cimetidine. They may also interfere with or be interfered by other drugs. Patients should report all medications to their doctors.

Rebound Insomnia, Dependence, and Tolerance. The risk for rebound insomnia, dependence, and tolerance is lower with non-benzodiazepine hypnotics than with benzodiazepine drugs. These drugs are still subject to abuse. In any case, no hypnotic should be taken for more than 7 – 10 days or at higher than the recommended dose without a doctor’s approval.

Benzodiazepine Hypnotics

Benzodiazepines used to be the most commonly prescribed sedative hypnotics. Originally developed in the 1960s to treat anxiety, these drugs nonselectively target receptor sites in the brain that modulate the effects of the GABA neurotransmitter.

Brands. Commonly prescribed benzodiazepines:

  • Long-acting benzodiazepines include flurazepam (Dalmane, generic), clonazepam (Klonopin, generic), and quazepam (Doral).
  • Medium- to short-acting benzodiazepines include triazolam (Halcion), lorazepam (Ativan), alprazolam (Xanax), temazepam (Restoril), oxazepam (Serax), and estazolam (ProSom), which are all available as generics. Short-acting benzodiazepines may be useful for air travelers who want to reduce the effects of jet lag.

Side Effects. Elderly people are more susceptible to side effects and should usually start at half the dose prescribed for younger people. They should not take long-acting forms.

Side effects may differ depending on whether the benzodiazepine is long or shorting acting. They include:

  • Severe allergic reactions, including facial swelling, can occur even with the first use of a benzodiazepine drug.
  • Respiratory problems may occur with overuse or in people with pre-existing respiratory illness
  • The drugs may increase depression, a common co-condition in many people with insomnia.
  • Respiratory depression (abnormally slow and shallow breathing) may occur with overuse or with people with pre-existing respiratory illness.
  • Long-acting drugs have a very high rate of residual daytime drowsiness compared to other types of sleeping pills. They have been associated with a significantly increased risk for automobile accidents and falls in the elderly, particularly in the first week after taking them. Shorter-acting benzodiazepines do not appear to pose as high a risk.
  • Memory loss, sleepwalking, sleep driving, eating while asleep, and other odd mood states may occur. These effects are enhanced by alcohol.
  • Urinary incontinence may occur, particularly in older patients and when taking long-acting formulations.
  • Because these drugs cross the placenta and enter breast milk, pregnant women or nursing mothers should not use them. Benzodiazepine use in the first trimester of pregnancy may be associated with the development of cleft lip in newborns.
  • In rare cases, overdoses can be fatal.

Interactions. Benzodiazepines are potentially dangerous when combined with alcohol. Some medications, like the ulcer medication cimetidine, can slow the metabolism of the benzodiazepine.

Withdrawal Symptoms. Withdrawal symptoms usually occur after prolonged use and indicate dependence. They can last 1 – 3 weeks after stopping the drug and may include:

  • Gastrointestinal distress
  • Sweating
  • Disturbed heart rhythm
  • In severe cases, patients might hallucinate or experience seizures, even a week or more after the drug has been stopped.
  • The chances for rebound insomnia are higher with the short-acting benzodiazepines than with the longer-acting ones.


Antidepressants are sometimes used to treat insomnia that may be caused by depression (secondary insomnia). In addition, certain types of antidepressants with sedating properties are prescribed for the treatment of primary insomnia, generally in lower doses than used to treat depression.

For example, the antidepressant trazodone (Desyrel, generic) is prescribed in low doses as a hypnotic to help induce sleep. A very low dose formulation of the tricyclic antidepressant doxepin (Silenor) is approved for treatment of insomnia. Other antidepressants used for insomnia include the tricyclics trimipramine (Surmontil, generic) and amitriptyline (Elavil, generic) and the tetracyclic antidepressant mirtazapine (Remeron, generic). Care should be taken in the use of trazodone and other sedating antidepressants in elderly patients, due to the risk for side effects (daytime sleepiness, dizziness, priapism, and increased risk of falls) and drug interactions.

Herbs and Supplements

More than 1.5 million Americans use complementary and alternative therapies to treat insomnia. Many people choose herbal and dietary supplement remedies. (Valerian and melatonin are among the most popular alternative remedies for insomnia.) Some, such as chamomile tea or lemon balm, are generally harmless for most people. Others have more serious side effects and interactions.

The American Academy of Sleep Medicine (AASM) advises that there is only limited scientific evidence to show that herbal and dietary supplements are effective sleep aids. The AASM recommends that these products should be taken only if approved by a doctor. Be sure to talk to your doctor if you are considering taking any herbal or dietary supplement. Some of these products can interact with prescription medications.

Generally, manufacturers of herbal remedies and dietary supplements do not need FDA approval to sell their products. Just like a drug, herbs and supplements can affect the body’s chemistry, and therefore have the potential to produce side effects that may be harmful. There have been a number of reported cases of serious and even lethal side effects from herbal products. Patients should always check with their doctors before using any herbal remedies or dietary supplements.

Melatonin. Melatonin is the most studied dietary supplement for insomnia. It appears to reduce the time to fall asleep (sleep onset) and the time spent asleep (sleep duration). However, there are no consistent standards on melatonin doses. Some research suggests that 0.3 mg may be the most effective dosage in many people with insomnia. However, higher doses may keep some people awake and may also cause mental impairment, severe headaches, and nightmares. Although melatonin may not have many benefits for most people with chronic insomnia, studies suggest that it may help travelers with jet lag and people with delayed sleep syndrome.

Valerian root. Valerian is an herb that has sedative qualities and is commonly used by people with insomnia. Some studies have indicated that it may help improve the quality of sleep, but there have been few rigorous and well-conducted trials to prove it is effective.

Kava. Kava has been used to relieve anxiety and improve sleep. It is dangerous. There have been reports of liver failure and death from this herb, with highest risk in those with liver disease. Kava can interact dangerously with certain medications, including alprazolam, an anti-anxiety drug. Kava also increases the strength of certain other drugs, including other sleep medications, alcohol, and antidepressants. Do not use this herb.

Tryptophan and 5-L-5-hydroxytryptophan (HTP). Tryptophan is an amino acid used in the formation of the neurotransmitter serotonin, which is associated with healthy sleep. L-tryptophan used to be marketed for insomnia and other disorders but was withdrawn after contaminated batches caused a rare but serious and even fatal disorder called eosinophilia myalgia syndrome. 5-HTP, a byproduct of tryptophan, is still available as a supplement. There is little evidence that 5-HTP relieves insomnia.

Resources — American Academy of Sleep Medicine — National Center for Sleep Disorders Research — National Sleep Foundation — Your Sleep from the American Academy of Sleep Medicine


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Source: Insomnia | University of Maryland Medical Center

University of Maryland Medical Center

Sexology and the Media

Sexology and sexual matters are often in the news. We hear about recent developments in our understanding od sexuality and improved methods and techniques to address sexual difficulties.

Unfortunately from time to time we also hear about problems with  services and allegations of misconduct against “sexologists”.

SASH, once again, wishes to bring the following to the attention of the public:

The South African Sexual Health Association is a voluntary, multidisciplinary, participation association of health care practitioners, practicing in sexual medicine/health, within the parameters of their respective professions. Membership is restricted to Practitioners registered with the Health Professions Council of South Africa which is a statutory regulatory and disciplinary body, tasked with the maintenance of academic standards within the profession and the protection of the public.

The South African Sexual Health Association exists ti assist in the ongoing professional development of its members anf to inform the public on sexual matters.

For the benefit of the public SASHA wishes to highlight the following:

  1. There is no accredited specialisation in South Africa in sexual medicine or sexology
  2. There is no SAQA accredited training in Sexual Medicine – Prospective students of sexology please read the press release from HPCSA.
  3. Members of SASHA who practice in the field of sexology, do so within the ambit of their registered professional qualifications, and many have received post graduate training in sexology from overseas institutions.
  4. Members of the public, when seeking assistance for sexual conditions are strongly advised to check the credentials of the person they seek to consult, by checking on their membership with SASHA and with the Health Professions Council of South Africa here