Do you often ask yourself, “Why am I so tired all the time?” If so, this article may be the perfect read for you; we have compiled a list of some of the most common reasons for tiredness and what you can do to bounce back into action.
woman yawning at her computer

There are many reasons for tiredness, including a lack of sleep, poor diet, a sedentary lifestyle, stress, and medical conditions.

According to the Centers for Disease Control and Prevention (CDC), around 15.3 percent of women and 10.1 percent of men regularly feel very tired or exhausted in the United States.

Tiredness can cause an array of problems. For example, around 1 in 25 adult drivers report falling asleep at the wheel each month.

About 72,000 crashes and 44,000 injuries each year are a result of drowsy driving, and that’s not to mention the estimated 6,000 fatal crashes caused by drowsy drivers.

Everyone feels tired at some point in their lives — whether it’s due to a late night out, staying up to watch your favorite TV show, or putting in some extra hours at work.

Often, you can put your finger on the reason you’re not feeling your best, but what about those times when you can’t pinpoint the cause of your tiredness? What makes you feel tired then?

Medical News Today have researched the possible explanations for why you could be feeling so drained and the steps that you can take to feel re-energized.

1. Lack of sleep

A lack of sleep may seem an obvious reason for feeling tired, yet 1 in 3 U.S. adults are consistently not getting enough of it.

man falling asleep in a car

Tiredness increases the risk of accidents, obesity, high blood pressure, depression, and heart disease.

People aged between 18 and 60 years need 7 or more hours of sleep every day to promote optimal health, according to The American Academy of Sleep Medicine and the Sleep Research Society.

Getting under the recommended hours of sleep each night is not only associated with fatigue, impaired performance, and a greater risk of accidents, but it also has adverse health outcomes.

These include obesity, high blood pressure, depression, heart disease, stroke, and an increased risk of death.

If you struggle to fit in 7 hours of sleep, here are some tips to help you achieve a full dose of much-needed slumber:

  • Maintain a consistent sleep routine. Try to go to bed at the same time every night and get up at the same time each morning — even on the weekends.
  • Avoid naps. We need a certain amount of sleep within a 24-hour period and no more than that. Napping reduces the amount of sleep that we require the following night, which might lead to difficulty getting to sleep and fragmented sleep.
  • Limit time awake in bed to 5–10 minutes. If you find that you are lying awake in bed worrying or with your mind racing, get out of bed and sit in the dark until you are feeling sleepy, then go back to bed.
  • Ensure that your bedroom is quiet, dark, and a comfortable temperature. Any light that enters your room could disturb your sleep. Ensure that your room is dark and that light emitted from digital devices is out of sight. Cooler room temperatures are considered better to promote sleep than warmer temperatures.
  • Limit caffeinated drinks. Try not to consume caffeinated beverages after noon. The stimulating effects of caffeine can last for many hours after intake and cause issues with initiating sleep.
  • Avoid tobacco and alcohol before bed. Smoking cigarettes and drinking alcohol before going to bed may cause fragmented sleep.

If you practice all the sleeping habits listed above and still wake up tired, it might be a good idea to contact your healthcare provider and discuss whether you have a sleep-related medical problem such as insomnia, obstructive sleep apnea, or restless legs syndrome.

2. Poor diet

The easiest way to banish tiredness is to make adjustments to your diet. Eating a healthful and balanced diet can make the world of difference to how you feel.

selection of healthy foods

Eating a healthful and balanced diet can help to combat fatigue.

To improve your health and get all the nutrients you need — as well as eliminate fatigue — it is vital to choose a healthful mix of food from the five food groups, which are: fruits, vegetables, grains, protein, and dairy.

You can switch up your eating style today by implementing some of these small changes:

  • Eat the right amount of calories for your sex, age, weight, and activity level. Eating either too much or too little can make you feel sluggish.
  • Fill half of your plate with fruits and vegetables. Be sure to focus on eating whole fruits and a selection of vegetables.
  • Ensure whole grains make up half the grains you consume. Examples of whole grains include brown rice, oatmeal, whole cornmeal, bulgur, and whole-wheat flour.
  • Shift to low-fat and fat-free dairy to help limit your calories from saturated fats.
  • Vary your protein routine. Try to choose lean poultry and meat, limit processed meats, choose unsalted nuts and seeds, and select some omega-3-rich seafood.
  • Cut down on sugar. Sugar can give you a quick rush of energy, but it wears off fast and might make you feel more tired. Avoid foods and drinks that have lots of added sugar.
  • Never skip breakfast. Regularly skipping breakfast can lead to you missing out on key nutrients and the energy that you need to kick-start your day.
  • Eat at regular intervals. Sustain your energy levels by eating three meals per day and limiting unhealthful snacks.
  • Drink enough water. Drinking water can help to prevent dehydration, which results in fatigue, unclear thinking, mood changes, overheating, and constipation.

3. Sedentary lifestyle

When tiredness sets in, sitting on the couch and relaxing could seem to be the only answer. But getting up and moving may be the best thing you can do to re-energize and eradicate fatigue.

older man riding a bike

Exercising can help to increase energy and reduce tiredness.

Research by the University of Georgia (UGA) in Athens discovered that compared with sitting quietly, one single bout of moderate-intensity exercise lasting for at least 20 minutes helped to boost energy.

An earlier study by UGA also found that when sedentary individuals completed an exercise program regularly, their fatigue improved compared with those who did not.

The U.S. Department of Health and Human Services Physical Activity Guidelines for Americans suggest that all adults need 2 hours and 30 minutes of moderate-intensity exercise per week and muscle-strengthening activities that work all the major muscle groups on 2 or more days per week.

This may seem to be a lot of time spent exercising, but you can spread out your activity across the week and, in total, it is just the amount of time that you might otherwise spend watching a movie.

If you have not exercised for a while, start slowly. Begin with a brisk 10-minute walk each day and build up to walking fast for 30 minutes on 5 days per week.

Brisk walking, water aerobics, riding a bike, playing tennis, and even pushing a lawnmower can all count toward your time spent doing moderate-intensity exercise.

4. Excessive stress

Many situations can cause stress. Work, financial problems, relationship issues, major life events, and upheavals such as moving house, unemployment, and bereavement — the list of potential stressors is never-ending.

man looking stressed

Excessive stress can lead to physical and emotional exhaustion.

A little stress can be healthy and may actually make us more alert and able to perform better in tasks such as interviews, but stress is only a positive thing if it is short-lived.

Excessive, prolonged stress can cause physical and emotional exhaustion and lead to illness.

Stress makes your body generate more of the “fight-or-flight” chemicals that are designed to prepare your body for an emergency.

In situations such as an office environment where you can’t run away or fight, the chemicals that your body has produced to protect you can’t be used up and, over time, can damage your health.

If the pressures that you face are making you feel overtired or giving you headaches, migraines, or tense muscles, don’t ignore these signals. Take some time out until you feel calmer, or try some of these tips.

  • Identify the source of stress. Until you can recognize what is causing you to create and maintain stress, you will be unable to control your stress levels.
  • Keep a stress journal to identify patterns and common themes.
  • Learn to say no. Never take on too much — be aware of your limits and stick to them.
  • Avoid those who stress you out. If there is someone in your life causing you a significant amount of stress, try to spend less time in their company.
  • Communicate your concerns. Learn to express your feelings and concerns instead of keeping them bottled up if something is bothering you.
  • View situations in a different way. Try to look at stressful situations in a more positive light. For example, if you’re stuck in a traffic jam, see it as an opportunity to have some alone time and listen to your favorite tunes.
  • Look at the bigger picture. Think about whether the stressful situation will matter in a month’s time. Is it worth getting upset about?
  • Accept the things you are unable to change. Some sources of stress, such as an illness or the death of a loved one, are unavoidable. Often, the best way to deal with stress is to try and accept things the way they are.
  • Learn to forgive. We are all human and often make mistakes. Let go of anger, resentments, and negative energy by forgiving friends, family, and colleagues and moving on.

Physical activity is a significant stress reliever and releases feel-good endorphins. If you are feeling stress build up, go for a walk, take your dog out, or even put on some music and dance around the room.

5. Medical conditions

If you have made lifestyle changes to do with your physical activity, diet, stress levels, and sleep but still feel tired all the time, there could be an underlying medical condition.

doctor holding clipboard with anemia written on it

Many medical conditions, such as anemia, can make you feel tired.

Some of the most common conditions that report fatigue as a key symptom include:

  • anemia
  • underactive thyroid
  • diabetes
  • anxiety
  • depression
  • chronic fatigue syndrome
  • urinary tract infection
  • food intolerance
  • heart disease
  • glandular fever
  • pregnancy
  • vitamin and mineral deficiencies

If you are concerned that you have a medical condition that is causing you to feel tired, arrange an appointment with your healthcare provider to discuss your worries as soon as possible.

Researchers from Duke University in Durham, NC, may have discovered a new way of killing off cancer cells.
t cells attacking cancer cellsThe modified poliovirus appears to enable T cells to attack cancer cells (shown here).

The team was jointly led by Dr. Matthias Gromeier, a professor in the Department of Neurosurgery, and Prof. Smita Nair, who is an immunologist in the Department of Surgery.

The new research – which is published in the journal Science Translational Medicine – shows how a modified poliovirus enables the body to use its own resources to fight off cancer. The modified virus bears the name of recombinant oncolytic poliovirus (PVS-RIPO).

PVS-RIPO has been in clinical trials since 2011 and preliminary results have offered hope to patients with one of the most aggressive forms of brain tumor: recurrent glioblastoma. So, the researchers set out to investigate more deeply how exactly PVS-RIPO works.

Explaining the rationale behind their research endeavor, Dr. Gromeier says, “Knowing the steps that occur to generate an immune response will enable us to rationally decide whether and what other therapies make sense in combination with poliovirus to improve patient survival.”

Poliovirus attacks tumors, inhibits regrowth

The researchers examined the behavior of the poliovirus in two human cell lines: melanoma and triple-negative breast cancer. They observed that the poliovirus attaches itself to cancerous cells. These cells have an excess of the CD155 protein, which acts as a receptor for the poliovirus.

Then, the poliovirus starts to attack the malignant cells, triggering the release of antigens from the tumor. Antigens are toxic substances that the body does not recognize, therefore setting off an immune attack against them.

So, when the tumor cells release antigens, this alerts the body’s immune system to start attacking. At the same time, the poliovirus infects the dendritic cells and macrophages.

Dendritic cells are cells whose role it is to process antigens and “present” them to T cells, which are a type of immune cell. Macrophages are another type of immune cell – namely, large white blood cells whose main role is to rid our bodies of debris and toxic substances.

The cell culture results – which the researchers then verified in mouse models – showed that once PVS-RIPO infects the dendritic cells, these cells “tell” T cells to start the immune attack.

Once started, this process seems to be continuously successful. The cancer cells continue to be vulnerable to the immune system’s attack over a longer period of time, which appears to stop the tumor from regrowing.

As Prof. Nair explains, “Not only is poliovirus killing tumor cells, it is also infecting the antigen-presenting cells, which allows them to function in such a way that they can now raise a T cell response that can recognize and infiltrate a tumor.”

This is an encouraging finding, because it means the poliovirus stimulates an innate inflammatory response.”

Prof. Smita Nair

Speaking to Medical News Today about the clinical implications of the findings and the scientists’ directions for future research, Dr. Gromeier said, “Our findings provide clear rationales for moving forward with clinical trials in breast cancer, prostate cancer, and malignant melanoma.”

“This includes novel combination treatments that we will pursue,” he added.

More specifically, he explains, because the study revealed that after treatment with the poliovirus “immune checkpoints are increased on immune cells,” a future strategy the researchers plan to explore is “[oncolytic] poliovirus combined with immune checkpoint blockade.”

Could a doctor’s visit one day result in a prescription for chocolate? According to a new study, it is possible. Researchers suggest that consuming a small amount of chocolate every day may lower the risk of diabetes and heart disease.
[A woman eating dark chocolate]Eating chocolate every day could lower the risk of diabetes and heart disease, say researchers.

Study co-author Prof. Saverio Stranges – visiting academic of the University of Warwick Medical School, United Kingdom, and scientific director of the Department of Population Health at the Luxembourg Institute of Health (LIH) – and colleagues publish their findings in the British Journal of Nutrition.

Chocolate is often perceived as a treat that should only be enjoyed from time to time. Given its high fat and sugar content, this is no surprise; overconsumption can lead to health problems, such as tooth decay and obesity.

However, studies are increasingly suggesting regular, moderate chocolate consumption may yield significant health benefits, particularly when it comes to dark chocolate.

Dark chocolate has the highest cocoa content, which means it has the highest levels of antioxidants – specifically, flavonoids – which are molecules that can prevent some forms of cell damage.

For their study, Prof. Stranges and colleagues analyzed the chocolate consumption of 1,153 people aged 18-69 who were part of the Observation of Cardiovascular Risk in Luxembourg (ORISCAV-LUX) study.

Data on chocolate intake were gathered from participants’ completion of a food frequency questionnaire.

The team set out to investigate whether chocolate intake is associated with insulin resistance – where the body’s cells do not effectively respond to insulin, raising the risk for type 2 diabetes and heart disease.

They also assessed how chocolate consumption affected liver enzyme levels, which is a measure of liver function.

Reduced insulin resistance with daily chocolate consumption

The researchers found that 81.8 percent of the study participants consumed chocolate, with an average consumption of 24.8 grams daily.

Compared with participants who did not eat chocolate every day, those who did were found to have reduced insulin resistance and improved liver enzyme levels. The effect was stronger the higher the chocolate consumption, the team reports.

The findings remained after accounting for participants’ age, sex, education, lifestyle, and dietary factors that could affect the results.

Dietary factors included intake of tea and coffee rich in the antioxidants polyphenols, which the researchers say have the potential to spur chocolate’s benefits for cardiometabolic risk.

Cardiometabolic risk refers to a person’s likelihood of developing diabetes, heart disease, or stroke.

Participants who ate chocolate were more physically active, younger, and more highly educated than those who did not eat chocolate, according to the authors.

Could dark chocolate be included in dietary recommendations?

Prof. Stranges and colleagues say their findings suggest that chocolate consumption may reduce the risk of developing cardiometabolic disorders by improving liver enzyme levels and protecting against insulin resistance.

Given the growing body of evidence, including our own study, cocoa-based products may represent an additional dietary recommendation to improve cardiometabolic health; however, observational results need to be supported by robust trial evidence.

Potential applications of this knowledge include recommendations by healthcare professionals to encourage individuals to consume a wide range of phytochemical-rich foods, which can include dark chocolate in moderate amounts.”

Prof. Stranges

However, Prof. Stranges notes that it is important to distinguish the difference between chocolate that contains natural cocoa and processed chocolate; the latter is much higher in calories.

“Therefore, physical activity, diet and other lifestyle factors must be carefully balanced to avoid detrimental weight gain over time,” he adds.

When we wake up in the morning, many of us reach for a coffee to kick-start our day. According to the International Coffee Organization, approximately 1.6 billion cups of coffee are consumed worldwide every day.

The US Food and Drug Administration (FDA) state that the average amount of caffeine consumed in the US is approximately 300 mg per person per day – the equivalent to between two and four cups of coffee. This is considered to be a moderate caffeine intake, which according to many studies, can promote a variety of health benefits.

But some studies claim otherwise, even suggesting that one or two cups of coffee a day may negatively impact our health. So, what are we to believe?

We analyze the potential health benefits, as well as the negative side effects of caffeine consumption.

Caffeine is a natural stimulant

The main ingredient in coffee is caffeine – a compound that naturally derives from over 60 different plant sources, including coffee beans, tea leaves, cacao seeds and cola nut seeds.

Caffeine acts as a stimulant by activating the central nervous system. It can combat tiredness and improve concentration and focus.

According to the University of Michigan Health Service, the stimulating effects of caffeine can start as early as 15 minutes after consumption and last up to 6 hours.

Other than coffee, caffeine is commonly consumed through tea, soft drinks – particularly energy drinks – and chocolate. It is also found in some prescription and non-prescription drugs, such as cold, allergy and pain medication.

Caffeine’s potential health benefits

As well as its stimulating effects, caffeine has been heralded for providing an array of health benefits.

A cup of coffee surrounded by coffee beans

Some studies have suggested that drinking three or four cups of coffee a day may reduce the risk of liver, mouth and throat cancer.

Last year, Medical News Today reported on a study suggesting that consuming three cups of coffee a day may reduce the risk of liver cancer by 50%, while another study suggests that drinking four cups a day could halve the risk of mouth and throat cancer.

Caffeine consumption has also been associated with positive effects on the brain.

Last year, a study from the Harvard School of Public Health suggested that drinking between two and four cups of coffee a day may reduce suicide risk in adults, while more recent research found that ingesting 200 mg of caffeine each day may boost long-term memory.

Other studies have also suggested that caffeine intake may protect against type 2 diabetes, Parkinson’s disease, cardiovascular disease and stroke.

Caffeine: the ‘socially acceptable psychoactive drug’

With so much research claiming that caffeine consumption can benefit our health, and considering the number of products that contain the stimulant, it is no wonder caffeine consumption is so widespread.

But Steven E. Meredith, postdoctoral research fellow at The Johns Hopkins University School of Medicine, told Medical News Today that, perhaps due to widespread consumption, many of us forget that caffeine is a psychoactive substance – a drug that crosses the blood-brain barrier to stimulate the central nervous system.

He said:

Unlike most other psychoactive substances, caffeine use is socially acceptable, and the drug is widely used. In fact, caffeine is the most commonly used psychoactive substance in the world.

Moreover, the vast majority of caffeine consumers use the substance regularly without apparent harm. These factors likely contribute to the perspective that caffeine is a benign substance that everyone can use without suffering any negative consequences.”

The negative effects of caffeine consumption

But of course, there can be negative consequences from caffeine consumption, particularly if ingested in high doses.

The Mayo Clinic state that consuming more than 500-600 mg of caffeine a day may lead to insomnia, nervousness, restlessness, irritability, an upset stomach, a fast heartbeat and even muscle tremors.

However, previous research has linked even moderate amounts of caffeine to negative health effects.

Last year, Medical News Today reported on a study suggesting that consuming 300 mg of caffeine a day during pregnancy may increase the risk of low birth weight babies, while other research suggests that drinking four cups of coffee a day may increase the risk of early death.

Effects of caffeine vary from person to person

But Meredith told us that the effects of caffeine can vary in each individual, which may explain why there are mixed messages surrounding whether caffeine is good or bad for us.

For example, he said that individuals with anxiety disorders are more susceptible to the anxiogenic effects of the compound.

Silhouette of person smoking a cigarette and holding a cup of coffee.

Cigarette smokers can metabolize caffeine twice as fast as non-smokers.

“Caffeine can also metabolize at different rates among individuals for various reasons. For example, cigarette smokers metabolize caffeine twice as fast as non-smokers,” he added.

“However, caffeine metabolism is slower among infants, pregnant women and individuals with liver disease. In addition, some medications slow caffeine metabolism, which may increase the risk for caffeine intoxication. But the effects of caffeine also vary simply because we’re all different.”

Rob M. Van Dam, adjunct associate professor of the Department of Nutrition at the Harvard School of Public Health, told Medical News Today that the effects of caffeine are dependent on each person’s genetic characteristics and lifestyle factors.

“Thus, some people may have difficulty sleeping or experience tremors or stress with relatively low caffeine intakes and it is useful to be aware of these symptoms and reduce caffeine intake if these occur,” he added.

Caffeine addiction and withdrawal

Given the positive effects caffeine can have as a stimulant, Meredith told Medical News Today that for some people, this can result in caffeine addiction:

Caffeine activates many of the same behavioral and neuropharmacological mechanisms that are activated by other reinforcers, including other drugs of abuse.

And, like many other reinforcers, caffeine is associated with various positive subjective effects like increased wellbeing, sociability, and feelings of energy and alertness. For this reason and others, a small percentage of the population develops caffeine use disorder.”

He said that some people can become physically dependent on caffeine, with absence or reduction of coffee consumption in these individuals resulting in caffeine withdrawal.

This can trigger symptoms such as headache, fatigue, drowsiness, depression, irritability, concentration difficulties, nausea and vomiting.

“Dependence can become so strong for some individuals that they’re unable to reduce consumption despite knowledge of recurrent physical or psychological problems associated with continued use,” Meredith added.

Kids and adolescents ‘should avoid caffeine consumption’

Meredith said that based on the negative side effects caffeine consumption can have, doctors should be discussing caffeine use with their patients to determine whether they are ingesting safe levels of the stimulant.

Furthermore, he warned that this is particularly important for children and adolescents.

Bottles of different soft drinks.

Pediatricians recommend that children should steer clear from caffeine, often found in soft drinks.

The majority of pediatricians recommend that this population should avoid caffeine consumption, particularly since it is unknown as to how excessive caffeine intake impacts the developing brain.

Notably, caffeine interferes with sleep, and sleep plays a critical role in learning. Some laboratory research suggests that caffeine interferes with sleep and learning among adolescent rodents, which, in turn, hinders normal neurological development that is noticeable into adulthood,” said Meredith.

“Some psychologists are also concerned that a pattern of caffeine use or abuse among young people may lead to subsequent problematic drug and alcohol use.”

The FDA clearly hold a similar view to pediatricians. In May last year, the organization announced it would be investigating the safety of caffeine in food products, particularly products aimed at children and adolescents.

The FDA are concerned that many food and drink products, such as jelly beans, waffles, syrup and chewing gum, now have caffeine added to them to enhance their stimulating effect.

Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the FDA, said:

We’re particularly concerned about children and adolescents and the responsibility FDA and the food industry have to protect public health and respect social norms that suggest we shouldn’t be marketing stimulants, such as caffeine, to our children.”

Meredith told us that studies have shown high caffeine intake may also produce negative side effects in pregnant women and individuals with heart conditions or anxiety disorders.

However, he added that the majority of us consume caffeine in moderation without any harmful side effects, so healthy adults should not be overly concerned.

“But we should be mindful that when we consume caffeine, we are consuming a psychoactive substance that can cause or exacerbate some health problems,” he cautioned.

The first drug to treat sexual dysfunction in premenopausal women – dubbed the “female Viagra” – has received approval from the US Food and Drug Administration.
FlibanserinFlibanserin has been approved by the FDA to treat premenopausal women with low sexual desire.
Image credit: G. Breed/Associated Press

Manufactured by Sprout Pharmaceuticals, flibanserin (brand name Addyi) has been given the green light by the federal drug agency for the treatment of hypoactive sexual desire disorder (HSDD) – a condition characterized by low sexual desire.

It is estimated that around 1 in 10 women develop HSDD, and up to 40% experience the condition at some point in their lives. Psychological factors, such as low self-esteem, stress or mental health problems may contribute to low sexual desire, as well as hormone changes or physical factors, such as fatigue or lifestyle habits.

While the exact mechanisms by which flibanserin works is unclear, Sprout Pharmaceuticals believe it corrects an imbalance in brain chemicals that are responsible for sexual desire.

The US Food and Drug Administration (FDA) say a 100-mg dose of the drug should be taken once daily just before bedtime. Patients should discontinue use if they experience no improvement in sexual desire within 8 weeks.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” says Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA.

“The FDA strives to protect and advance the health of women,” she continues, “and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

Flibanserin only to be prescribed by certified health care professionals, pharmacies

The FDA reached their decision by conducting an analysis of three randomized, double-blind, placebo-controlled trials involving around 2,400 women of an average age of 36 years who had HSDD.

For a 24-week period, the women took either a placebo or a 100-mg dose of flibanserin before bedtime. The women who took flibanserin reported a modest increase in sexual desire and the number of sexual events during the study period, as well as a reduction in distress as a result of low sexual desire.

On assessing the safety of the drug, the FDA report the most common adverse reactions identified were nausea, dizziness, fatigue, sleepiness, insomnia and dry mouth.

However, the organization notes flibanserin is also associated with hypotension – severely low blood pressure – and loss of consciousness, particularly if taken with alcohol. Such side effects have led the FDA to reject the drug twice previously – once in 2010 and again in 2014.

As such, their approval of flibanserin comes with a risk evaluation and mitigation strategy (REMS), which requires that all prescribers enroll in and complete a training program before treating patients with the drug.

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

In addition, a Boxed Warning is being applied to flibanserin, informing patients about the risk of hypotension and concussion if taken with alcohol, as well as warning patients with liver impairment or those taking moderate or strong CYP3A4 inhibitors to avoid use of the drug.

The FDA also require that Sprout Pharmaceuticals carry out three well-designed studies in order to further assess the health risks associated with flibanserin on interaction with alcohol.

FDA approval likely to attract mixed reactions

While many women and health care professionals may welcome the FDA’s decision to approve flibanserin, others are likely to have concerns.

Back in June, a Spotlight from Medical News Today investigated whether flibanserin will really help women with low sexual desire.

Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria in British Columbia, told us she was not convinced the current evidence of flibanserin’s safety and efficacy would be enough to gain FDA approval.

“I have faith that the FDA will stand its ground and not approve flibanserin,” she said. “If they do, they are sending a very dangerous message – that drug companies and their marketing machines can pressure them into approving drugs that are unsafe and ineffective.”

While the FDA’s approval of flibanserin comes with conditions reflecting their safety concerns, the decision has still been met with criticism, with one health expert hailing it a “sad day for drug regulation.”

“What has been learned since the last disapproval is that it has more risks than we thought and it doesn’t have any more benefits. The only thing that’s different is a clever, aggressive public relations campaign that Sprout Pharmaceuticals waged successfully,” Adriane Fugh-Berman, a pharmacology professor at Georgetown University in Washington, DC, told The Washington Post.

“This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It’s bad news for rational drug approval,” she adds.

Despite this criticism, Cindy Whitehead, CEO of Sprout Pharmaceuticals, believes the FDA’s decision to approve flibanserin is the right one:

It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life-impacting condition.

We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

Flibanserin will be available from mid-October, according to Sprout Pharmaceuticals, and is expected to cost between $30 and $75 a month for women with medical insurance.