Stavigile (Modafinil) is commonly used to help manage Excessive Daytime Sleepiness (EDS), a symptom that interferes with daily functioning. The medication is generally applied across therapeutic domains where additional symptomatic support is needed to promote wakefulness. The primary conditions it addresses include Narcolepsy, residual sleepiness in patients with Obstructive Sleep Apnea (OSAHS), and Shift Work Sleep Disorder (SWSD).

Therapeutic Focus and Relief

Stavigile is used to help address symptom clusters that may become intense or disruptive in these conditions. This support may contribute to easing distress and assists with maintaining functional stability and sustained alertness. The medication is considered relevant in contexts marked by increased discomfort due to circadian misalignment or chronic somnolence.

In these situations, the medication provides supportive relief when symptoms interfere with routine activities, assisting with the maintenance of functional stability. For instance, when treating OSAHS, Stavigile is applied in addressing residual excessive sleepiness that persists even after primary treatment with CPAP, and contributes to easing the impact of persistent, debilitating somnolence. It may assist with easing the overall symptom burden during required waking hours, whether during day-shifts or night-shifts.

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Quick Fact: Relief for Pathological Sleepiness
Stavigile is commonly used to help manage the pathological somnolence that defines key sleep-wake disorders, rather than mild or situational fatigue.

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Regulatory References

1. NIH MedlinePlus Drug Information on Modafinil

Who Can and Cannot Use Stavigile? — Official Regulatory Information

The eligibility for Stavigile (Modafinil) is defined strictly by regulatory labeling, which establishes specific contraindications and restrictions based on patient population and medical history. The medicine is officially approved for use in adults (typically ge 17 or ge 18 years of age) with excessive sleepiness associated with Narcolepsy, Obstructive Sleep Apnea, or Shift Work Disorder.

Contraindicated Populations	Restricted or Limited Use Populations
Known hypersensitivity to modafinil or armodafinil.	Pediatric population (under 18 years): Use is not recommended; safety is not established.
Uncontrolled moderate to severe hypertension or cardiac arrhythmias.	Severe hepatic impairment: Dose must be reduced by one-half.
Pregnant women or women planning to conceive.	Geriatric patients (ge 65 years): Requires lower doses and close monitoring.
Patients with a history of left ventricular hypertrophy or cor pulmonale.	Patients with a history of psychosis, mania, or substance abuse: Use with caution.

Use is contraindicated during pregnancy, and women of child-bearing potential using hormonal contraceptives must use alternative or concomitant non-hormonal contraception during treatment and for two months afterward. Stavigile is not recommended for the pediatric population, and its use in older adults requires special consideration and dose reduction due to the potential for reduced clearance.

Interactions with other medicines and products

Stavigile (modafinil) has the potential to alter the way the body processes certain other medicines, primarily due to its effects on hepatic enzymes. It is documented to be an inducer of CYP3A4/5 and a reversible inhibitor of CYP2C19.

Medications Affected by Stavigile

Affected Medicine Category	Practical Implication (Constraint or Requirement)
Hormonal Contraceptives (e.g., those containing ethinyl estradiol)	Effectiveness may be reduced. Alternative or concomitant non-hormonal contraception is recommended during treatment and for one to two months after stopping Stavigile.
CYP3A4/5 Substrates (e.g., cyclosporine, triazolam)	Exposure may be decreased due to increased clearance. Monitoring and/or dosage adjustment of the co-administered drug may be necessary.
CYP2C19 Substrates (e.g., diazepam, phenytoin, omeprazole)	Exposure may be increased due to reduced clearance. Monitoring for increased effects and potential dosage reduction of the co-administered drug should be considered.
Warfarin and other CYP2C9 Substrates	Clearance may be reduced. Prothrombin times must be monitored regularly during the first two months of co-administration and after dosage changes to manage bleeding risk.

Interaction Profile Summary

The documented interaction profile is structured around Stavigile's metabolic enzyme modulation, which necessitates specific risk management actions. Regulatory agencies require explicit labeling about the risk of contraceptive failure with steroidal contraceptives and the need for rigorous monitoring of drugs with narrow therapeutic indices, such as warfarin, when co-administered. The drug's dual effects on CYP enzymes mean it can either decrease or increase the circulating levels of various co-administered medicines.

Modulation of Core Arousal Neurotransmitters

This mechanism block addresses the drug’s direct molecular interactions, specifically its action as a weak inhibitor of the Dopamine Transporter (DAT) and its role as a partial agonist at alpha1B adrenergic receptors. By slowing the clearance of dopamine and stimulating adrenergic receptors, Stavigile increases the availability of key arousal-promoting chemical messengers, initiating its physiological effect.

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The Central Orexin Activation Cascade

The increased presence of dopamine and norepinephrine indirectly leads to the activation of the Orexin (Hypocretin) system in the hypothalamus. This system is a master regulator of stable wakefulness. This activation results in the widespread release of orexin, which amplifies signaling across the brain and drives the sustained, heightened state of vigilance and alertness.

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️ Influencing the Balance of Brain Activity

The combined cascade ultimately results in a shift in the chemical environment in the brain. Stavigile decreases inhibitory signaling (via GABA) while increasing excitatory signaling (via Glutamate) in critical brain circuits. This modulation of the excitatory-inhibitory balance contributes to the overall wake-promoting effect by influencing natural regulatory forces that mediate transitions toward rest. The mechanism results in the maintenance of a physiologically aroused state.

Instruction Map: How to use Stavigile — Administration Guidelines

Property	Instruction
Route of administration	Oral (tablet), swallowed whole.
Dosing schedule	The standard dose is 200 mg once daily. Doses up to 400 mg per day may be used in certain regimens, although consistent benefit beyond 200 mg is not established for certain indications.
Timing in relation to meals (if applicable)	May be taken with or without food, as food does not impact overall absorption.
Preparation requirements (if applicable)	None beyond swallowing the tablet whole.
Age-group administration rules	Severe Hepatic Impairment: Dose must be reduced by half (e.g., to 100 mg daily). Older Adults: A lower starting dose (e.g., 100 mg daily) should be considered due to potential slower clearance. Pediatric Patients: Not established for use under 17 years.
Missed-dose rules	If a dose is missed, skip the dose and resume the normal schedule; a double dose should not be taken.
Special procedural conditions	For Shift Work Disorder (SWD), the dose is taken approximately one hour prior to the start of the work shift. For Obstructive Sleep Apnea, patients must continue using any primary treatment like CPAP.

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Instruction Classifications (High-Level)

Classification	Detail
Administration method type	Oral
Frequency pattern	Daily (once per day)
Use-context constraints	Timing is condition-dependent; dose reduction is specified for severe liver impairment.

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Resulting Procedural Structure

Step sequence:

• The tablet is administered orally, typically in the morning for narcolepsy or OSA, or one hour before a work shift for SWD.
• The standard 200 mg dose may be adjusted up to 400 mg/day, but must be halved (to 100 mg) for patients with severe hepatic impairment.
• Patients should not take a double dose to compensate for any missed timing.

Connection to the overall use protocol

The administration parameters for Stavigile include a fixed oral route, 200 mg to 400 mg dose boundaries, and specific timing and dose modifications for certain populations, defining the framework for standardized administration.

Stavigile: Recent Clinical Evidence

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Evidence for Use in Narcolepsy

Research involving the compound Stavigile was evaluated in individuals with Narcolepsy, utilizing short-term, placebo-controlled, double-blind Randomized Controlled Trials (RCTs). Researchers monitored objective measures of the ability to maintain wakefulness (e.g., MWT) and subjective measures capturing patient-reported sleepiness (e.g., ESS). Studies describe patterns observed in the research related to both objective test results and patient-reported scores. However, long-term effects are not fully established by high-quality, controlled evidence, as follow-up durations were limited, typically only a few weeks. Data related to other key features of Narcolepsy, such as cataplexy events, remains limited.

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Evidence for Use in Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Research involving Stavigile was observed in individuals with residual excessive daytime sleepiness in OSAHS, coming mainly from short-term, placebo-controlled RCTs. The compound was examined for its use as an addition to primary treatment (CPAP). The research examined outcomes reflecting daily functioning and used measures of objective wakefulness and subjective sleepiness. The research framework does not examine the underlying breathing issues associated with OSAHS itself.

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Evidence for Use in Chronic Shift Work Sleep Disorder (SWSD)

Research involving Stavigile was examined in individuals with SWSD through short-term, controlled trials. These studies primarily measured objective alertness and attention during the scheduled work period and collected subjective patient-reported outcomes. Data show patterns related to performance on vigilance tests administered during the work shift compared to placebo. As with other indications, the existing evidence is limited for long-term outcomes, with follow-up durations typically restricted to a few weeks.

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Long-Term Research, Uncertainty, and Specific Patient Groups

Most rigorous research was observed in the short-term category. Consequently, long-term effects are not fully established by controlled trials; extended follow-up data primarily originate from less rigorous open-label extension studies. Findings describe group patterns, not personal outcomes. Key limitations include insufficient data for comparative evidence with other agents, and limited research on specific patient groups. Research involving Stavigile has been evaluated in adolescents, though data remains insufficient compared to the adult population, and data for older adults or those with specific comorbidities is often limited.

Key Studies & References Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy | ClinicalTrials.gov (NCT00107796)

Common questions about Stavigile (FAQ)

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Q: What are the long-term effects of taking Stavigile?

Most clinical studies supporting the formal approval of Stavigile were conducted over short periods, typically lasting only a few weeks. Because of this, the full range of long-term effects beyond several months are not fully established by high-quality controlled evidence. Official information indicates that the drug's effectiveness has been maintained in some subjects for up to 40 weeks of use.

Q: Are there any common over-the-counter supplements that should be avoided while taking Stavigile?

Official information advises patients to always inform their healthcare provider about all medicines, vitamins, and herbal supplements they are using. Some specific herbal products, such as St. John's wort, are noted in regulatory guides as potentially interfering with how the drug is processed by the body.

Q: Does Stavigile interact with alcohol, even in small amounts?

It is advised in regulatory documents to avoid drinking alcohol while using Stavigile. Official information suggests that this combination may potentially increase the risk of certain side effects, such as dizziness and nausea.

Q: Is there a generic version of Stavigile available?

Yes, the active ingredient in Stavigile is Modafinil, and a generic version of this compound has been reviewed and approved by regulatory agencies, making it available in the marketplace.

Q: What should I do if I experience a rash while taking Stavigile?

Regulatory documents state that the medication should be discontinued at the first sign of a rash, unless the rash is clearly unrelated to the drug. Due to the potential for severe reactions, prompt medical attention is advised if a rash develops.

Q: Is Stavigile known to be habit-forming?

Stavigile is classified by the government as a Schedule IV controlled substance. This official scheduling indicates that the drug has a known potential for abuse and dependence. The potential for abuse and dependence is a constraint noted in the official safety information.

Q: Does Stavigile show up on standard drug tests?

The drug itself is not typically included in routine, standard drug screenings designed to detect common substances. However, specialized laboratory testing methods do exist that are capable of detecting the compound and its major breakdown products (metabolites) in the body.

Q: Are there any foods that interact negatively with Stavigile?

The official product labeling or associated guides warn that the consumption of grapefruit and grapefruit juice should be discussed with a healthcare provider. This caution is advised because grapefruit can potentially interfere with the breakdown of the medicine in the body.

Q: How long after stopping Stavigile does it take for the drug to clear the system?

According to regulatory clinical pharmacology sections, the time it takes for half of the drug to be eliminated from the bloodstream (the half-life) is approximately 12 to 15 hours. Complete clearance of the drug from the body takes a longer period.

Q: Can Stavigile affect mood or cause emotional changes?

Official safety information notes that serious psychiatric events are documented adverse reactions associated with the medication. These include the potential for emotional changes such as anxiety, depression, mania, or the onset of psychosis.

Q: Is Stavigile a new drug, or has it been around for a while?

The active ingredient in Stavigile, Modafinil, has been available for use for several years. It was first formally approved by the U.S. Food and Drug Administration (FDA) in 1998.

Q: Are there studies on Stavigile's effect on driving performance?

Clinical trials for the drug often use objective measures like vigilance tests to assess performance during wakefulness. Official guides state that patients should not operate a car or machinery until they have determined how the drug influences their performance.

Q: Does Stavigile interact with pain relievers like ibuprofen or acetaminophen?

The primary drug-drug interactions described in the regulatory literature involve drugs metabolized by specific liver enzymes. Interaction checks based on official data typically report no known interaction with common over-the-counter pain relievers such as ibuprofen or acetaminophen.

Q: Are there any known interactions with herbal teas or natural products?

Official information advises patients to always inform their healthcare provider about all medicines, vitamins, and herbal supplements or natural products they are using. Some specific herbal products are noted in regulatory guides as potentially interfering with the drug's metabolism.

Q: How quickly can someone expect to feel the effects of Stavigile?

According to the clinical pharmacology data in official documents, the maximum concentration of the drug in the blood, which relates to the peak of its effect, is typically reached approximately two to four hours after the tablet is taken orally.

Q: What is the average duration of action for Stavigile?

Regulatory documents indicate that the drug has an elimination half-life of 12 to 15 hours. This supports its prolonged wakefulness-promoting effect, with documented actions lasting for an average of 11 to 12 hours.

Q: Does Stavigile help with focus or concentration?

Clinical studies supporting the drug's use in certain indications, such as shift work disorder, have measured its impact on objective alertness and attention during the work shift.

Q: Can Stavigile be taken by people with kidney problems?

Official safety information advises that caution is needed for patients with severe renal insufficiency (kidney problems). Due to the potential for the main breakdown product of the drug to build up in the body, close monitoring may be considered.

Q: Is it necessary to have a special monitoring or testing while on Stavigile?

Official documents describe that close monitoring of heart rate and blood pressure is relevant during treatment. Additionally, specific testing is required when Stavigile is taken alongside certain medicines like warfarin.

Q: Does the effectiveness of Stavigile decrease over time (tolerance)?

Clinical studies reviewed by regulatory bodies have not demonstrated that the loss of effectiveness, or drug tolerance, is a common adverse effect when Stavigile is used therapeutically. Efficacy was maintained in controlled trials lasting up to 40 weeks.

Storage Conditions

Official regulatory labeling requires Stavigile tablets to be stored at Controlled Room Temperature, which is between 68^circF and 77^circF (20^circC and 25^circC).

The container must be kept tightly closed to protect the medication from excess moisture and heat, and it should be kept from freezing. As a Schedule IV controlled substance, the product must be stored in a safe place and kept out of the reach of children to prevent theft or accidental ingestion.

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️ Disposal Instructions

When the medication is no longer needed, the preferred method for disposal is to use a drug take-back program or mail-back envelope. If these options are not readily available, the FDA recommends disposing of the controlled substance in the household trash by mixing it with an undesirable material (like used coffee grounds or dirt) in a sealed container before discarding. All disposal must follow local requirements.