Modalert – Uses, Dosage, Precautions, Interactions

Modalert (Modafinil)

Used for Narcolepsy, Obstructive sleep apnea, Shift Work Disorder
Dosage forms Tablets
Strengths 100mg, 200mg
Method of administration Taken with or without food orally
Prescription Required
Alternatives Alertec, Alertex, Altasomil, Aspendos, Forcilin, Intensit, Mentix, Modafinilo, Modanil, Modasomil, Modvigil, Modiodal, Modiwake, Movigil, Provigil, Resotyl, Stavigile, Vigia, Vigicer, Vigil, Vigimax, Wakelert and Zalux
Pharmacokinetics Onset of action : 2-4 hours
Duration of action : For highest strength it is upto 8 hours

Indications and Clinical Use

  • Indicated for the treatment of excessive sleepiness (Narcolepsy) in adult patients, shift work type disorder (i.e people working in shifts having irregular sleep cycle) (SWD).
  • Also indicated for the treatment of Obstructive sleep apnea (OSA) ,a sleeping disorder, where breathing suddenly stops for a short time during night.
  • Used for the treatment of hypersomnia (excessive daytime sleepiness).

Limitations

  • Without proper medical confirmation on sleeping disorder one should not use this medicine.

Different brands of modafinil:

Brand name
Manufacturer
Modalert Sun Pharmaceutical Industries Ltd
Provigil Cephalon, Inc.
Modvigil Hab Pharma
Modapro Cipla Limited
Modatec Cipla Limited
Provake Ranbaxy Laboratories Ltd.
Modifil Psyco Remedies

Dosage and Administration

  • The recommended dosage of Modafinil for patients who have Narcolepsy is 200 mg taken orally once a day in the morning.
  • Maximum daily dose up to 400 mg/day is well tolerated as divided doses for patients who are not responding.
  • For patients with SWD, 200 mg is taken orally once a day as a single dose approximately 1-hour before they start to their work shift.

Over dosage

  • Don’t take more than the prescribed dosage in a day. Over dosage results in side effects like hallucinations, sleeping, increase in blood pressure etc.
  • If you forget to take Modafinil skip the dose for the day.

How it works

  • Modafinil activates central nervous system.
  • It binds to dopamine transporter in brain and inhibits dopamine reuptake and increases dopamine concentrations.

Side effects

  • Headache is a very common side effect seen in people using this drug

Here are some common side effects.

  • Dizziness.
  • Nervousness
  • Sleepiness, extreme tiredness, difficulty in sleeping (insomnia).
  • Increased or decreased heart rate (Tachycardia & Bradycardia).
  • Chest pain
  • Skin turning red (erythema).
  • Dry mouth.
  • Asthenia
  • Dyspnea (Difficulty in breathing)
  • Sinusitis
  • Gastrointestinal disorders like Loss of hunger, stomach pain, indigestion, diarrhea or constipation.
  • Weakness.
  • Numbness or tingling of the hands or feet
  • Blurred vision.
  • Abnormal blood test results showing how your liver is working (increased liver enzymes such as GGT (Gamma glutamyl transferase, Alkaline Phosphatase)).
  • Irritability
  • Serious Rash, including Stevens – Johnson syndrome (a serious disorder of skin and mucous membrane)
  • Multi-organ Hypersensitivity Reactions

Here are some adverse reactions identified during post approval use of Modafinil.

  • Blood disorders: agranulocytosis
  • Psychiatric disorders: psychomotor hyperactivity

Who shouldn’t use:

  • Who have an irregular heartbeat.
  • Who have severe high blood pressure (hypertension)
  • Who have depression, low mood, anxiety, mania (over-excitement or feeling of extreme happiness) because it may make your condition worse.
  • If you have kidney or liver problems.
  • If you are pregnant or a nursing mother avoid taking modafinil it may cause birth defects and it is excreted in human milk.
  • Patients taking this medication should not involve in sports as it acts as doping agent.

Precautions

Before taking modafinil tell your Doctor or Pharmacist that

  • You have allergic reactions for any medicine you have used in the past.
  • You should avoid driving and operating heavy machinery as it may cause dizziness and drowsiness.
  • Don’t take other medicines (Over the counter drugs) without consulting your Doctor as it may interact with other drugs.
  • You shouldn’t drink alcohol as it may cause excessive drowsiness.

Drug Interactions

  • Modafinil may increase metabolism of ciclosporin, oral contraceptives.
  • It may increase the effects of warfarin, TCAs (tricyclic antidepressants) & CYP2C19 substrates (e.g citalopram, diazepam, methsuximide, phenytoin, propanolol, sertraline).
  • Effects of Modafinil may be reduced with CYP3A4 inducers (e.g aminoglutethimide, carbamazepine, naficillin, nevirapine, phenobarbital, phenytoin, rifamycins).
  • Effects of Modafinil may be increased by CYP3A4 inhibitors (e.g azole antifungals, clarithromycin, diclofenac, doxycycline, erthromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, verapamil).

Differences between Modvigil and Modalert

  • The main difference between the two drugs is that Modalert is considered more effective than Modvigil. Modvigil is a generic drug and it is less potent.

Pharmacokinetics

Absorption

  • After administering modafinil it is readily absorbed, reaches the blood circulation and shows its action within 2-4 hours.

Distribution

  • After reaching human plasma it binds to plasma proteins mainly albumin.

Elimination

  • Major route of elimination is by liver enzymes (CYP Enzymes), with subsequent excretion in the urine. Less than 10% of the dose is excreted as unchanged drug.
  • The elimination half-life is approximately 12-15 hours.

Is modafinil a controlled substance?

  • It is a controlled substance in USA due to its addiction potential.

Addictive or not?

  • Modafinil is known to cause dependence so people who have a history of drug abuse and addiction should not take this medicine.

Also, read our article on – Clonazepam – Uses, Side effects, Precautions

References

Posted by V.L.Priyanka

V.L.Priyanka is a registered pharmacist with more than 5+ Years of experience in Research & Development in leading Pharmaceutical Industries. Also, she is a Technical Editor and Founder of a medical information oriented blog. She completed masters in Pharmacy.

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