Provigil Side Effects Center

Drug Description

Provigil is known as a dopamine reuptake inhibitor, which stimulates the release of histamine and orexin neuropeptides in your body. Provigil (modafinil) doesn’t cure sleep disorder, but it’s prescribed to increase wakefulness in patients with excessive sleepiness related disorder, and obstructive sleep apnea/hypopnea syndrome.

Provigil is a white to off-white, crystalline powder that is practically insoluble in cyclohexane and water and sparingly soluble in acetone and methanol. The tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: povidone, lactose monohydrate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. This is also very similar with the components found in Waklert 150, but only about half of the overall modafinil dosage present.

While Provigil seems like the wonder drug that might solve sleep disorder with a high chance of being misused, it’s important to be aware of the risk before you take it.

 

Medication Guide

What should I tell my physician before taking Provigil?

Tell your physician about all your previous medical conditions including, if you:

• Have high blood pressure.
• Have liver or kidney problems.
• Have heart problems or heart attack.
• Have a history of mental health problems.
• Have a history of drug/alcohol abuse or addiction,
• Are allergic to any of the ingredients in Provigil.
• Are pregnant or planning to become pregnant.

How do I take Provigil?

• Take Provigil as prescribed by your doctor.
• Do not change your Provigil dose unless you talked to your doctor.
• Do not change the time you take Provigil without talking to your doctor.
• People with SWD should take Provigil about 1 hour before their work shift
• People with narcolepsy or OSA should take Provigil 1 time each day in the morning.
• If you take more Provigil dose than prescribed or if you consume an overdose of Provigil, contact your doctor right away.

 

Provigil Consumer Information

 

Provigil side effects

Provigil carries many side effects as with any prescription medication. If a person with modafinil prescription is experiencing side effects, their doctor can adjust the dosage and eliminate these dangerous complications. Provigil can cause skin reactions that may need doctor attention in a hospital. Get emergency medical help and stop taking this medicine if you have:

• Swelling in your legs
• Trouble swallowing, mouth sores
• Shortness of breath, Fever
• Burning, tingling or numbness of the skin
• Skin rash or peeling skin or hives, blisters
• Swelling in your face, lips, tongue, eyes, or throat.

Contact your doctor and Stop using modafinil if you have:

• Hallucinations, behavior, aggression or unusual thoughts, talkative than usual or being more active
• Anxiety, depression, suicidal thoughts or actions
• Trouble breathing, Chest pain, uneven heartbeats
• Common side effects may include:
• Feeling nervous or anxious
• Back pain
• Headache, dizziness
• Sleep problems (insomnia)
• Loss of appetite
• Difficulty seeing or eye pain
• Nausea, diarrhea, upset stomach
• Stuffy nose
• Excessive thirst and dry mouth

Abusers of Provigil are likely to experience side effects that could land them in a hospital. Contact your doctor or pharmacist if you notice other effects not listed above.

Modafinil overdose

Typical modafinil dose is 200 mg once a day. Consuming more amount could lead to overdose. However, It is possible to overdose on modafinil, if combined with other drugs or alcohol. Many symptoms of modafinil overdose are similar to the drug’s severe side effects. Modafinil overdose symptoms include:

• Nausea
• Diarrhea
• Agitation
• Confusion
• Chest pain
• Hallucinations
• Restlessness
• Nervousness or anxiety
• Slow, fast or pounding heartbeat
• Difficulty falling or staying asleep
• Uncontrollable shaking of a body part

Contact a poison control center if you are experiencing any of these side effects after taking a large amount of the drug.

 

Interaction & Dosage

 

Modafinil interactions

It’s vital to inform your doctor about any other medications you’re taking, including prescription drug, over-the-counter, herbal and vitamins products before starting modafinil. Drugs that may interact with modafinil include:

• Propranolol (Inderal)
• Rifampin (Rifadin, Rimactane, Rifater)
• Cyclosporine (Sandimmune, Neoral, Gengraf)
• Propranolol or Inderal, Cyclosporine/ Neoral, Sandimmune phenobarbital (Luminal, Solfoton), Carbamazepine (Tegretol, Carbatrol), or phenytoin (Dilantin)
• Antifungal medications like ketoconazole (Nizoral) or itraconazole (Sporanox)
• A sedative such as midazolam (Versed), diazepam (Valium), or triazolam (Halcion)
• Seizure medication such as phenytoin (Dilantin), carbamazepine (Tegretol, Carbatrol), or phenobarbital (Solfoton, Luminal)
• An MAO inhibitor such as phenelzine (Nardil), isocarboxazid (Marplan), rasagiline (Azilect), tranylcypromine (Parnate) or selegiline (Eldepryl, Emsam)
• Antidepressants such as amitriptyline (Etrafon, Elavil), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil, Janimine), and others.

Modafinil dosage

Modafinil comes in two strengths, 200 mg, and 100 mg. It is usually taken one hour before the start of a work shift for patients with narcolepsy or in the morning to prevent daytime sleepiness.

The recommended dosage for patients with narcolepsy or OSA is 200 mg taken orally once a day while for patients with SWD is also 200 mg taken orally. The dosage should be reduced to one-half (100 mg) for patients with severe hepatic impairment and closely monitored.

You may also be given a CPAP (continuous positive airway pressure) machine if you are using the medication to treat obstructive sleep apnea. The air pump blows pressurized air into your nose while you sleep when connected to a mask to keep your airways open and prevent obstruction.

Clinical Trials Experience

Provigil clinical trials have been evaluated for safety in over 3,500 patients, with more than 2,000 patients having excessive sleepiness associated with OSA, SWD, and narcolepsy. These trials are conducted under widely varying conditions, adverse reaction rates, which cannot directly be compared to other drugs, are observed.

Most Common Adverse Reactions

Common adverse reactions associated with the frequent use of Provigil in placebo-controlled clinical trials, were nausea, headache, nervousness, rhinitis, diarrhea, back pain, insomnia, anxiety, dyspepsia, and dizziness. The table below shows the adverse reactions that occurred at 1% rate or more in Provigil-treated patients than in placebo-treated patients.

 

Adverse Reactions in Pooled Placebo-Controlled Trials in OSA, SWD, and Narcolepsy

 

	Provigil (%) (n = 934)	Placebo (%) (n = 567)
Headache	34	23
Headache	11	3
Nervousness	7	3
Rhinitis	7	6
Back Pain	6	5
Diarrhea	6	5
Anxiety	5	1
Dizziness	5	4
Dyspepsia	5	4
Insomnia	5	1
Anorexia	4	1
Dry Mouth	4	2
Pharyngitis	4	2
Chest Pain	3	1
Hypertension	3	1
Abnormal Liver Function	2	1
Constipation	2	1
Depression	2	1
Palpitation	2	1
Paresthesia	2	0
Somnolence	2	1
Tachycardia	2	1
Vasodilatation	2	0
Abnormal Vision	1	0
Agitation	1	0
Asthma	1	0
Chills	1	o
Confusion	1	0
Dyskinesia	1	0
Edema	1	9
Emotional Liability	1	0
Eosinophilia	1	0
Epistaxis	1	0
Flatulence	1	0
Hyperkinesia	1	0
Hypertonia	1	0
Mouth Ulceration	1	0
Sweating	1	0
Sweating	1	0
Thirst	1	0
Tremor	1	0
Urine Abnormality	1	0
Vertigo	1	0

Adverse Reactions that happened in 1% of PROVIGIL treated patients (either 400, 300, and 200 mg once daily) and higher incidence than placebo.

 

Adverse Reactions for Dose-Dependent

Headaches and anxiety were dose-related adverse reactions in the placebo-controlled clinical trials, which compared doses of 400, 300 and 200 mg/day of Provigil and placebo.

 

Adverse Reactions due to Discontinuation of Treatment

74 patients out of 934 patients approximately 7% who received PROVIGIL discontinued due to an adverse reaction in placebo-controlled clinical trials when compared to 3% of patients that received placebo. A headache, anxiety, nausea, dizziness, chest pain, insomnia, and nervousness were the reason why there is a higher rate of discontinuation for PROVIGIL than placebo patient.

 

Laboratory Abnormalities

Clinical chemistry, urinalysis, and hematology parameters were monitored in the research. Following administration of PROVIGIL, mean plasma levels of alkaline phosphatase (AP) and gamma-glutamyltransferase (GGT) were found to be higher. Few patients had AP, or GGT lifts high out of the normal range. Alkaline phosphatase (AP) and gamma-glutamyltransferase (GGT) values appeared to increase with PROVIGIL in the placebo-controlled clinical trials. No differences were apparent in aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, or total bilirubin.

 

Post-marketing Experience

Provigil adverse reactions have been identified during post-approval use because these reactions are reported voluntarily from a population of uncertain size. However, it’s challenging to estimate their frequency or establish a causal relationship to drug exposure.

 

Abuse

Provigil produces euphoric and psychoactive effects, alterations in mood, thinking, perception, and feelings in human. In vitro binding research, modafinil binds to the dopamine and causes an increase in extracellular dopamine, but no increase in dopamine release. Some research discriminates modafinil as stimulant-like. Patients using Provigil should be monitored for signs of abuse or misuse. Its essential physicians should follow patients closely, especially those with a history of drug and stimulant abuse.

 

Dependence

The effects of Provigil (modafinil) withdrawal were monitored following nine weeks of modafinil use in one placebo-controlled clinical trial. Although sleepiness returned in narcoleptic patients, there was no report of withdrawal symptoms with modafinil during 14 days of observation.

 

Mechanism of Action

Provigil (modafinil) has wake-promoting actions similar to sympathomimetic agents like methylphenidate and amphetamine. The α1-adrenergic receptor antagonist and prazosin can attenuate modafinil-induced wakefulness. Modafinil is not a direct or indirect acting-dopamine receptor agonist.

Its activity increases extracellular dopamine levels in some brain regions. A dopamine synthesis inhibitor, alpha-methyl-p-tyrosine, blocks the action of amphetamine but does not prevent locomotor activity induced by modafinil.

Modafinil produces euphoric and psychoactive effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans in addition to its wake-promoting effects and ability to increase locomotor activity in animals.

How to store Provigil

• Keep Provigil away from children and pet.
• Store Provigil at room temperature between 20° and 25° C.