Adrafinil 300 mg by Absorb Health

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. Although there is interest in using oral adrafinil for age-related cognitive decline, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Aging. Although there is interest in using oral adrafinil for prevention of aging, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Athletic performance. Although there is interest in using oral adrafinil for improving athletic performance, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Exercise-induced muscle damage. Although there is interest in using oral adrafinil for muscle recovery after exercise, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Mental alertness. Although there is interest in using oral adrafinil for mental alertness, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Obesity. Although there is interest in using oral adrafinil for weight loss, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose.
• Opioid withdrawal. Although there is interest in using oral adrafinil for opioid withdrawal, there is insufficient reliable information about the clinical effects of adrafinil supplements for this purpose. More evidence is needed to rate adrafanil supplements for these uses.

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POSSIBLY UNSAFE ...when used orally. Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to increase the risk of adverse cardiovascular and psychiatric events, including increases in blood pressure and heart rate. Although modafinil, and possibly adrafinil, might have addictive potential, the potential for abuse is low (104950,109229). However, there have been anecdotal reports of withdrawal symptoms following use of adrafinil, alone or in combination with other products (109225).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally. Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been associated with reports of intrauterine growth restriction and spontaneous abortion. Also, animal studies show that developmental toxicity occurs with use of modafinil during pregnancy (109603). Although modafinil, and possibly adrafinil, might have addictive potential, the potential for abuse is low (104950,109229). However, there have been anecdotal reports of withdrawal symptoms following use of adrafinil, alone or in combination with other products (109225). Avoid using.

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might reduce the effects of antihypertensive drugs.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to increase diastolic and systolic blood pressure. Retrospective analyses show that patients taking modafinil had a small but increased rate of requiring new antihypertensive drugs or increased use of antihypertensive drugs when compared with placebo (109603).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might reduce the levels and clinical effects of CYP1A2 substrates.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to weakly induce CYP1A2 activity in vitro (104950,109229,109603).

CYTOCHROME P450 2B6 (CYP2B6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might reduce the levels and clinical effects of CYP2B6 substrates.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to weakly induce CYP2B6 activity in vitro (104950,109229,109603).

CYTOCHROME P450 2C19 (CYP2C19) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might increase the levels and clinical effects of CYP2C19 substrates.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to inhibit CYP2C19 activity in vitro (109229,104950,109603).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might increase the levels and clinical effects of CYP2C9 substrates.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to reduce CYP2C9 expression in vitro (109229,104950).

CYTOCHROME P450 3A4 (CYP3A4) INHIBITORS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, drugs that inhibit CYP3A4 might increase the levels and clinical effects of adrafinil.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil is metabolized by CYP3A4 (104950,109603).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafanil might reduce levels and clinical effects of CYP3A4 substrates.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to weakly induce CYP3A4 activity (104950,109603).

MODAFINIL (Provigil) Interaction Rating = Major Do not take this combination. Severity = Moderate •  Occurrence = Likely •  Level of Evidence = D Concomitant use might increase the risk for serious adverse effects.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Concomitant use with modafinil would be expected to result in increased clinical and adverse effects (109603).

MONOAMINE OXIDASE INHIBITORS (MAOIs) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use might increase the risk for serious adverse effects.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil, and a related drug, armodafinil, have been associated with reports of serious adverse effects, such as hypertensive crisis and hyperthermia, when used in combination with MAOIs (109603,109604).

STIMULANT DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking adrafinil with stimulant drugs might have additive stimulant effects.  Details Adrafinil is a precursor to the prescription drug modafinil, which has stimulant effects (104950,109228).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, adrafinil might alter the effects and adverse effects of warfarin.  Details Adrafinil is a precursor to the stimulant prescription drug modafinil. Although pharmacokinetic research shows that modafinil does not alter levels of warfarin, this study was limited to a single dose. Experts recommend monitoring international normalized ratio (INR) in patients who are taking warfarin and initiating treatment with modafinil (109603).

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General ...There is limited reliable information available about the safe use of adrafinil. However, adrafinil is a precursor to the stimulant prescription drug modafinil and may cause similar adverse effects.
Most Common Adverse Effects:
Orally: Disturbed sleep, headache, malodorous urine, and unpleasant stimulation.
Serious Adverse Effects (Rare):
Orally: Orofacial dyskinesia.

Cardiovascular ...Adrafinil is a precursor to the stimulant prescription drug modafinil. Modafinil has been shown to increase heart rate and diastolic and systolic blood pressure. Hypertension and tachycardia have been reported (104950,109225,109229).

Dermatologic ...Adrafinil is a precursor to the stimulant prescription drug modafinil. Serious drug rashes, including erythema multiforme/Stevens Johnson syndrome (EM/SJS), have been reported following the use of modafinil (104950,109229).

Gastrointestinal ...Adrafinil is a precursor to the stimulant prescription drug modafinil. Nausea is a common adverse effect of modafinil. Decreased appetite is common in children and adolescents and may be related to weight loss (104950,109229).

Genitourinary ...Anecdotally, malodorous urine has been reported following intake of adrafinil. Severe dehydration was also reported anecdotally (109225). It is unknown if individuals reporting these symptoms were also taking other substances.

Neurologic/CNS ...Anecdotally, headache, poor concentration, irritability, sedation, disturbed sleep, unpleasant stimulation, and anxiety have been reported following intake of adrafinil (109225). It is unknown if individuals reporting these symptoms were also taking other substances.
Adrafinil is a precursor to the stimulant prescription drug modafinil. Insomnia, headache, and nervousness are common adverse effects of modafinil (104950,109229). There are also reports of orofacial dyskinesia related to use of adrafinil, as well as modafinil. In one case report, the development of orofacial dyskinesia occurred following the use of prescription adrafinil 900 mg daily for 10 months by a 75-year-old male. Adrafinil was withdrawn two months later and symptoms persisted for an additional 4 months. The patient was eventually maintained with tetrabenazine 25 mg daily (109226).

Psychiatric ...Anecdotally, feelings of withdrawal have been reported following cessation of adrafinil. Symptoms included fatigue, irritability, lack of focus, headache, and gastrointestinal symptoms (109225). It is unknown if individuals reporting these symptoms were also taking other substances.
Adrafinil is a precursor to the stimulant prescription drug modafinil. Although modafinil might have addictive potential, the potential for abuse is low and there are no known case reports (104950,109229).

Other ...Adrafinil is a precursor to the stimulant prescription drug modafinil. There is a single known case of multi-organ hypersensitivity leading to death following use of modafinil (104950,109229).

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