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Introduction

Excessive daytime sleepiness is defined as difficulty in staying awake or alert during day time with an overall feeling of lethargy and poor mental stimulation. The urge to sleep during the day is considered a disorder when the feeling subsists over a period of three months or more. Daytime sleepiness is often confused with fatigue because of the similar lack of energy with lethargy associated with either of them. The differentiating factor in these cases is sleep as daytime sleepiness results in increased drowsiness whereas fatigue may or may not be accompanied by sleep.

A word about Modalert

Modalert is the generic version of the eugeroic Modafinil used in the treatment of excessive sleepiness in daytime. Insomnia and disturbed circadian rhythms are a major reason for excessive sleepiness in daytime and in the UK the problem is especially prevalent. Research has proved that 36% of UK adults have difficulties in sleeping patterns on a weekly basis. Almost half of the total population of the UK has sleep problems on a monthly basis. Every one out of every five people has trouble sleeping at night. This results in daytime sleepiness and lack of alertness and focus in daytime. Impact of Covid has further worsened the problem.

Medications like Modalert or its counterparts are the chief treatment options in these cases. Apart from helping sleep disorder patients to lead a normal life they allow them complete their daily activities in a stimulated manner. A number of factors can result in daytime sleepiness. Here are some conditions in which Modalert has either been legally approved or successfully tested clinically for improving daytime sleepiness induced cognitive deficits.

Excessive sleepiness associated with Narcolepsy

Narcolepsy is a neurological disorder caused by lack of sleep regulating chemicals in the body. Usually narcolepsy is regarded as an immune related problem. But factors like stress, infection, flu or genetic traits can trigger the problem. Narcolepsy can significantly impact sleep cycles and decrease sleep quality. This can result in excessive sleepiness in daytime with decreased alertness and focus.

In a trial conducted to assess the impact of Modalert or its branded counterparts on narcolepsy 283 subjects were enrolled in a study. It was a placebo controlled, double blinded randomized study in which the subjects had been previously diagnosed with narcolepsy. Modalert 200/400 mg or placebo was administered to them for a period of 9 weeks followed by an open label treatment period. The results showed improvement in patients being treated with Modalert in comparison to placebo. Modalert showed tremendous improvement in their sleep disorder without any complications for upto 40 weeks.

Excessive sleepiness associated with SWSD

Shift Work Sleep Disorder (SWSD) is a sleep disorder affecting people working night shifts in which their work schedules go against their circadian rhythms. Approximately 10-40% of night shift workers suffer from sleep disorders resulting in headaches, dullness, difficulty concentrating and lack of energy.

In a 12 week double blind randomized study, 278 subjects diagnosed with chronic SWSD were administered branded Modalert or placebo respectively. Tablets were usually administered 30-60 minutes before each night shift. Results showed successful outcomes in people using Modalert in comparison to placebo. Modalert was established to significantly improve quality of life in patients with SWSD.

Daytime sleepiness associated with traumatic brain injury

In a single center, double blind, placebo controlled crossover trial, 53 subjects with TBI after 1 year of recovery were randomly selected to receive 400mg tablets or placebo tablets. Modafinil/ branded Modalert did appear to show improvements in the 4th week of use, but significant changes were not reported on noting the results of the study.

The study proved that Modalert has the potential to be beneficial in TBI patients with daytime sleepiness; but as of now requires more research before being approved for the same.

Modalert for day time sleepiness in PWS cases

PWS or Prader-Willi Syndrome is a genetic disorder resulting in obesity, intellectual disability and shortness in height. Apart from these symptoms, PWS is also characterized by excessive daytime sleepiness resulting in a disrupted routine of the patient.

In order to evaluate the efficacy of eugeroics in PWS cases, 10 subjects with molecularly confirmed PWS and complaints of excessive daytime sleepiness were administered 100mg Modafinil/ Modalert derivative once daily. Modalert use significantly improved the excessive sleepiness of the patients bringing the sleep levels from an Epworth scale of 14 to 4. Side-effects were not observed during the use of the drug. Modafinil acting as an effective treatment option for PWI, its generic version Modalert proved equally useful as an off label treatment option for PWI cases.

Modalert as adjunct treatment option for daytime sleepiness in Obstructive Sleep Apnea

Obstructive Sleep Apnea is a sleep related breathing disorder in which the throat muscles relax and block the airway during sleep. Snoring, excessive daytime sleepiness, morning headache, difficulty concentrating during daytime are some of the main symptoms observed as a result of obstructive sleep apnea.

In a study to observe the effects of Modalert for cases of Sleep Apnea, 32 subjects with untreated sleep apnea were selected for trials. 200mg Modalert or matching placebo were administered in a randomized manner for 2 weeks before crossing over to alternative treatment. The results of these trials proved that the primary outcome of sleep apnea improved significantly with branded Modalert/ Modalert derivative in comparison to placebo. Driving simulator performance and reaction time also improved with Modalert derivative use.

Modalert for cancer related fatigue

Excessive daytime sleepiness associated with fatigue and insomnia are among the most common symptoms in cancer patients. In a study of 37 cancer patients with varied causes of cancer, 100mg Modalert derivative was administered in an open label manner for 28 days. Results showed significant improvement in Fatigue Severity case and visual analogue scale without any adverse reactions. The results proved that Modalert has tremendous potential of improving excessive daytime sleepiness in cancer patients and enabling them an improved quality of life.

Modalert for ADHD induced daytime sleepiness

Attention Deficit Hyperactivity Disorder is a neurological disorder characterized by restless broken sleep at night among other symptoms. This leads to excessive sleepiness in daytime and poor cognitive functioning as a result of it.

In a double blind, placebo controlled study consisting of 46 patients, Modalert active ingredient/Modafinil was administered at a dose of 200-300mg per day. If the subject was less than 17 years, it was administered as per the weight of the subject. Trials were conducted upto 6 weeks with patients being assessed 14, 28 and 42 days after initiation of treatment. The results showed Modalert to significantly improve cognitive function and be well tolerated without serious adverse reactions. The study proved that Modalert had tremendous potential in emerging as the leading treatment option for sleep disorders in ADHD patients.

Modalert for day time sleepiness induced by multiple sclerosis

Multiple Sclerosis is characterized by an inflammatory reaction caused by the immune system attacking nerve fibers and myelin sheathing of CNS and spinal cord. The result is fatigue with poor sleep quality in turn resulting in daytime sleepiness, decreasing concentration and memory with inability to work effectively.

To assess the efficacy of Modalert in multiple sclerosis patients, 16 subjects diagnosed with multiple sclerosis were enrolled in a study. Modalert or its active component Modafinil were administered 200 mg of Modafinil for a period of 5 weeks. Treatment showed improvement in sleepiness and memory of the subjects. But fatigue parameters remained unchanged. The study proved that Modalert had the potential to improve cognitive aspects in MS patients. It could prove as an effective adjunct to clinical rehabilitation interventions.

 FDA approval, Schedule IV and generic status

Despite the efficacy of Modalert or its active ingredient for treatment of daytime sleepiness in the above mentioned problems, it has been approved for only 3 conditions. FDA has approved the use of Modalert only for cases of narcolepsy, SWSD and sleep apnea. In other conditions its use is off-label in clinical trials or as per the treatment plan of physicians.

The growing popularity of Modalert for improving cognitive function has led to its increasing use as a nootropic in healthy persons. This has resulted in it being declared a Schedule IV medication and it being made available strictly through prescription.

Modalert, unlike its active ingredient Modafinil, is a generic medication. Modafinil, despite its advanced cognitive abilities, is expensive and difficult to obtain. Modalert being Modafinil’s generic counterpart is cost effective and through online portals more easily obtained. This has made it more accessible to the common man with sleep disorder and enabled a greater part of the population access it for their medical conditions.

Safety parameters

Despite its increasing popularity and effectiveness, the use of Modalert is associated with side-effects and drug interactions. Headache, nausea and gastrointestinal issues are some of the less common issues associated with Modalert use. But overuse or misuse can result in life threatening complications. Similarly, using it with other drugs like anti-depressants, pain killers, anticancer medications or antibiotics can affect the metabolic rate of either drug or cause other complications.

Keeping this in mind, Modalert use should be done judiciously under the guidance of a licensed physician. Care should be taken to follow their instructions for use and after the stipulated time period, discontinue it in a tapering fashion to avoid major withdrawal symptoms.