Modafinil

What is Modafinil?

• Modafinil (Provigil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound.
• The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide.

Modafinil

Modafinil enantiomers

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What are the uses of this medicine?

Modafinil (Provigil) is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

• narcolepsy
• obstructive sleep apnea (OSA). Modafinil tablets are used to treat excessive sleepiness, but not the obstruction or medical condition that is causing OSA. You should talk with your doctor about treatments for OSA before you start taking modafinil tablets and during treatment with modafinil tablets. Modafinil tablets do not take the place of treatments that your doctor has prescribed for OSA. It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)

• Modafinil tablets will not cure these sleep disorders. Modafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Modafinil tablets do not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.

How does this medicine work?

• Modafinil (moe daf' i nil) is a non-amphetamine central nervous system (CNS) stimulant whose mechanism of action is not entirely clear.
• Modafinil is structurally unrelated to the amphetamines, and it does not appear to affect release of CNS norepinephrine or dopamine.
• Modafinil is a racemic mixture of S and R enantiomers, whereas armodafinil (ar" moe daf' i nil) is the R enantiomer only.
• Both enantiomers have CNS activating actions, but they differ in pharmacokinetics and half-life.
• Modafinil is known to be a weak inhibitor of dopamine reuptake, which may be its primary clinically important property. It has little to no in vivo affinity for the serotonin (5HT) or norepinephrine (NE) transporters.
• However, elevated concentrations of NE and 5HT in the prefrontal cortex and hypothalamus have been observed following modafinil administration, possibly as an indirect effect of increased extracellular dopamine.
• Additionally, modafinil has been postulated to increase signaling in the hypothalamic orexin and histamine neurotransmitter pathways, and animal studies have also suggested a glutamatergic effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic or developed a rash to modafinil (PROVIGIL) or armodafinil (NUVIGIL) or any of the ingredients in modafinil tablets.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• a hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs). Hormonal birth control methods may not work while you take modafinil tablets. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking modafinil tablets, and for one month after stopping modafinil tablets. Talk to your doctor about birth control choices that are right for you while taking modafinil tablets.
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• certain antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• cyclosporine (Neoral, Sandimmune)
• diazepam (Valium)
• certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin)
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• propranolol (Inderal)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• rifampin (Rifadin, Rimactane)
• triazolam (Halcion)

Is this medicine FDA approved?

• Modafinil was approved for medical use in the United States in 1998.

How should this medicine be used?

Recommended dosage: Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA):

• The recommended dosage of modafinil for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

Dosage in Shift Work Disorder (SWD):

• The recommended dosage of modafinil for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modifications in Patients with Severe Hepatic Impairment:

• In patients with severe hepatic impairment, the dosage of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function.

Use in Geriatric Patients:

• Consideration should be given to the use of lower doses and close monitoring in geriatric patients

Administration:

• Take modafinil tablets exactly as prescribed by your doctor. Your doctor will prescribe the dose of modafinil tablets that is right for you. Do not change your dose of modafinil tablets without talking to your doctor.
• Your doctor will tell you the right time of day to take modafinil tablets.
• People with narcolepsy or OSA usually take modafinil tablets 1 time each day in the morning.
• People with SWD usually take modafinil tablets about 1 hour before their work shift.
• Do not change the time of day you take modafinil tablets unless you have talked to your doctor. If you take modafinil tablets too close to your bedtime, you may find it harder to go to sleep.
• You can take modafinil tablets with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg and 200 mg.

This medicine is available in fallowing brand namesː

• Provigil

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• back pain
• nausea
• feeling nervous
• stuffy nose
• diarrhea
• feeling anxious
• trouble sleeping
• dizziness
• upset stomach

Less common, but serious side effects may include:

• a serious rash or serious allergic reaction

mental (psychiatric) symptoms, including:

• depression
• feeling anxious
• hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• an extreme increase in activity and talking (mania)
• thoughts of suicide
• aggressive behavior
• other mental problems

• symptoms of a heart problem, including chest pain, abnormal heartbeat, and trouble breathing.

What special precautions should I follow?

• Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of modafinil. Discontinue modafinil at the first sign of rash, unless the rash is clearly not drug-related.
• Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm), were observed in patients treated with armodafinil, the R enantiomer of modafinil (which is the racemic mixture). If suspected, discontinue modafinil.
• Multi-organ hypersensitivity reactions, have occurred to the initiation of modafinil. If suspected, discontinue modafinil.
• Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal. Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity.
• Psychiatric adverse reactions have been reported in patients treated with modafinil. Use caution in patients with a history of psychosis, depression, or mania. Consider discontinuing modafinil if psychiatric symptoms develop.
• Cardiovascular adverse reactions, including chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG occurred. Consider increased monitoring.
• Although modafinil has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Do not drive a car or do other dangerous activities until you know how modafinil tablets affect you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.
• You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking modafinil tablets.
• Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Caution patients regarding the potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with modafinil and for one month after discontinuation of therapy.
• Advise patients to notify their physician if they are breastfeeding an infant.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• trouble sleeping
• restlessness
• confusion
• feeling disoriented
• feeling excited
• hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• nausea and diarrhea
• a fast or slow heartbeat
• chest pain
• increased blood pressure

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• No specific antidote exists for the toxic effects of a modafinil overdose.
• Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

Can this medicine be used in pregnancy?

• It is not known if modafinil tablets will harm your unborn baby.
• There is a registry for women who become pregnant during treatment with modafinil tablets. The purpose of this registry is to collect information about the safety of modafinil tablets during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.
• Modafinil is not approved in this population for any indication.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: modafinil
• Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.

Who manufactures and distributes this medicine?

Manufactured for:

• Teva Pharmaceuticals
• Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store modafinil tablets at room temperature between 68° and 77° F (20° and 25° C).
• Keep modafinil tablets and all medicines out of the reach of children.

• Dailymed label info on Modafinil
• FDA Modafinil

Modafinil Resources
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