Modalert 200mg – The treatment options for insomnia
Insomnia is one of the most prevalent yet neglected problems missed by several physicians during preliminary examinations, but it severely affects a patient’s health. The incidence of the problem increases with age and in the presence of co-morbidities like diabetes or hypertension. Studies have shown that in addition to older people, sleep problems are both prevalent and increasing among students.
Based on polysomnography tests, insomnia can be split into either one with normal sleep duration when individuals can get greater than 6 hours of sleep or short sleep duration when the sleep duration is less than 6 hours.
Of the two, insomnia with objective short sleep duration is the more severe among them as it is associated with a higher risk of hypertension, impaired heart rate variability and activation of the limbs of the stress system. These problems impact the body’s endocrine, metabolic, gastrointestinal, and immune functions. Diabetes, neurocognitive impairment and increased mortality rates are a few complications that can occur following systemic changes.
In contrast, insomnia with objective normal sleep duration is associated with comparatively decreased intensity of symptoms. The problem becomes especially evident in shift workers and students with frequent changes in circadian rhythms, resulting in morning tiredness, reduced daytime functioning and overall impaired working of the system.
Wake-promoting drugs become the need of the hour in such conditions to reinforce the level of vigilance through a stimulated release of neurotransmitters implicated in the arousal threshold maintenance and shift the drive from the sleep-promoting to the wake-promoting system. Modalert is a well-tolerated drug with no impairment in sleep or cardiovascular parameters. Long-term studies suggest that the efficacy of Modalert is maintained with little likelihood of tolerance, and there are no adverse effects on scheduled sleep, demonstrating the beneficial effect of the drug on daily life and the working of the patient.
Modalert exerts its wake-promoting effects by stimulating the tuberomammillary nucleus and the hypocretinergic neurons, which activate the ascending reticular activating system. Out of numerous treatment options for insomnia, the use of Modalert has produced the most effective and long-lasting results.
Animal studies have shown Modalert to produce a cocaine-like subjective effect with a lower potency and efficacy than cocaine in producing cognitive stimulation. In addition, the subjective impact of Modalert was obtained at lower doses and earlier onset times than expected based on its dopaminergic effects. Morning-dosed Modalert promotes nocturnal sleep, normalizes sleep architecture, and decreases daytime sleepiness in abstinent cocaine users, that is the group most susceptible to sleep disorders.
Studies have further observed the effects to be more observable with 200 mg of Modalert than with the 100 mg dose, significantly impacting the sleepiness and fatigue scales. The efficacy of Modalert 200 mg was rated as good or excellent (using a 4-point scale) in 84 of 131 evaluable patients (64%) with excessive daytime sleepiness. Within nine weeks of use, significant improvements were observed in the daytime sleep latency, and daytime sleepiness of the subjects administered the drug.
In another study conducted to assess the effectiveness of 200mg Modalert, 209 patients with Shift Work Sleep Disorder were enrolled in a three-month double trial and administered 200 mg Modatert or placebo before the start of their shifts. Assessments were performed using the nighttime Multiple Sleep Latency Test, the Clinical Global Impression of Change, the Psychomotor Vigilance Test, the diaries of patients, and daytime polysomnography. Monthly assessments were conducted to evaluate the effects of Modalert.
Treatment with Modafinil, as compared with placebo, resulted in a modest improvement from baseline in mean nighttime sleep latency, the interval between the time a person attempts to fall asleep and the onset of sleep, and more patients had improvement in their clinical symptoms. Patients receiving Modafinil also had a reduction in the frequency and duration of lapses of attention during nighttime testing of their performance on the Psychomotor Vigilance Test. Proportionally fewer patients reported having had accidents or near accidents while commuting home. Headache was the most common adverse event. The study concluded that treatment with 200 mg of Modafinil reduced the extreme sleepiness that we observed in patients with shift-work sleep disorder and resulted in a small but significant improvement in performance compared to placebo. However, the residual sleepiness observed in the treated patients underscored the need for developing interventions that are even more effective.
It was earlier established that Cognitive Behavior Therapy is the preferred first-line treatment for chronic insomnia in adults. It has been endorsed as first-line therapy by multiple societies and guideline panels. But several insomniacs undergoing CBT fail to complete it because the acute reduction in total sleep time during the first few weeks of treatment results in side effects of daytime sleepiness.
In a study conducted to evaluate whether Modafinil, the active ingredient of Modalert, could be used to reduce daytime fatigue, sleepiness or both in primary insomnia conditions, 30 subjects diagnosed with primary insomnia were enrolled in a random study. The mean age of the group was 41.3 years, and 70.4% of the subjects enrolled were women. Apart from assessing the individual effects of Modafinil, the study additionally aimed at determining whether the use of Modafinil was enough to help an insomniac combat daytime sleepiness or needed to be combined with Cognitive Behaviour Therapy( a combination of sleep consolidation, stimulus control, cognitive restructuring, sleep hygiene, and relaxation technique) ;
Keeping the study’s guidelines in mind, the subjects were assigned to any one of three treatment conditions; placebo combined with cognitive behaviour therapy, Modafinil combined with cognitive behaviour therapy or Modafinil combined with a contact control that was required to be administered under physician’s supervision. Subjects were continuously monitored with sleep diaries from study intake until the study ended after ten weeks and subsequently evaluated weekly for changes in sleepiness.
The results of the study were favourable in all three groups. They showed good sleep latency( time taken by a person to fall asleep) and wake-up after sleep onset of 30 minutes without significantly altering the pre-treatment sleep profiles of the patient. Modafinil, when administered alone, did not significantly impact the patients’ sleep profiles but improved the sleep latency of the subjects. Modafinil, when administered concomitantly with Cognitive behaviour therapy, reduced daytime sleepiness and enhanced patients’ compliance with Cognitive Behaviour therapy. Subjects in the Modafinil plus CBT group more reliably adhered to the prescribed phase delay in bedtime than the placebo plus CBT group.
The study concluded that modafinil/ Modalert effectively diminished the side effects of Cognitive Behavior Therapy. It induced increased daytime sleepiness and even increased subject compliance with therapy.
Conclusion
According to The American Sleep Association, insomnia is the most common sleep disorder affecting 70 million Americans. Almost 30% of Americans have short-term insomnia, while 10% deal with long-term repercussions of the problem. Modalert 200 mg cannot work as a cure for insomnia but can significantly help in combating the daytime sleepiness problem as a result of insomnia conditions. Combining it with Cognitive behaviour therapy can work best in treating the condition and providing long-term symptomatic relief to the patient. At the same time, care must be taken to avoid misusing or overusing it as it is associated with the risk of addiction or increased tolerance.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353813/
https://onlinelibrary.wiley.com/doi/abs/10.1111/jsr.12790
https://pubmed.ncbi.nlm.nih.gov/16079371/
