A recently approved drug may help some people who struggle with excessive sleepiness. But it could be years before doctors are able to prescribe the new medication.
Nuvigil is the latest “wake-promoting agent” from drugmaker Cephalon Inc. In June the U.S. Food and Drug Administration approved it for the treatment of excessive sleepiness. Nuvigil can be prescribed for people who have one of these sleep disorders:
FDA approval gives Cephalon the green light to begin marketing Nuvigil. But Cephalon, based in Frazer, Penn., already sells the drug Provigil. It is the only FDA-approved, wake-promoting drug on the market.
Provigil earned FDA approval in December 1998. Cephalon began marketing it the following year. Cephalon reports that more than 10 million Provigil prescriptions were filled through 2006. These sales generated more than $2 billion in revenue.
Currently Cephalon holds a patent on Provigil. The patent prevents other companies from selling their own “generic” versions of the drug. Patents expire 20 years after the original date of filing.
FDA records indicate that the Provigil patent will expire in April 2015. Cephalon reports that Provigil’s future is “secure until 2012.” So in less than a decade the door will open for competitors to take a share of the “wakefulness” market.
Nuvigil will enable Cephalon to build on the success of Provigil. Cephalon touts Nuvigil’s “strong safety profile” and “improved efficacy.” According to Cephalon the approval of Nuvigil comes with “patent protection until 2023.” The company’s stated plan is to wait until the Provigil patent nears expiration before marketing Nuvigil.
Cephalon’s 2006 Annual Report estimates that the transition will begin sometime “around 2010.” Then Nuvigil will be marketed as a “next-generation treatment.”
Cephalon also plans to study Nuvigil as a possible treatment for other medical problems. One of these problems is excessive sleepiness due to Parkinson’s disease. Another is fatigue in people who are being treated for cancer.
More studies also may examine the overall safety of Nuvigil. Currently the Nuvigil label has a large, bold warning. It indicates that serious rash may occur as a side effect.
No rashes have been reported in clinical trials of Nuvigil. But some adults and children have been hospitalized for serious rashes after taking Provigil. The Nuvigil label contains the warning because the two drugs are closely related. The active ingredient in Nuvigil is armodafinil. This is part of the mixture that makes up modafinil, the active ingredient in Provigil.
The most common side effects of Nuvigil are:
- Headache
- Nausea
- Dizziness
- Insomnia
There also is a risk of these psychiatric problems:
- Depression
- Anxiety
- Hallucinations
- Suicidal thoughts
Nuvigil is a Class IV, federally controlled substance. Exactly how it promotes wakefulness remains unknown. Like other drugs that act as stimulants, Nuvigil can be abused or can lead to dependence.
The long-term effectiveness of Nuvigil has not been evaluated. It also has not been studied in pregnant women or in children. Lower doses may be required for elderly patients.
Although it improves wakefulness, Nuvigil does not eliminate sleepiness. It is not a replacement for sleep.
Nuvigil also does not treat the obstruction that causes OSA. In people with OSA Nuvigil must be used along with continuous positive airway pressure (CPAP) therapy.
Nuvigil Highlights
Active Ingredient: armodafinil
Maker: Cephalon Inc.
FDA Approval: June 15, 2007
Patent Expiration: 2023
Drug Class: Class IV, controlled substance
Approved Uses: Excessive sleepiness due to OSA, narcolepsy and shift work disorder
Pregnancy Safety: Category C — potential risk - no studies of Nuvigil in pregnant women
Nursing Safety: Unknown — use caution
Pediatric Safety: Unknown - no studies of Nuvigil in children
Elderly Safety: Has not been established
Time to Peak Potency: About 2 hours
Half-Life: About 15 hours
Strength: 50 mg, 150 mg, 250 mg
Form: White, uncoated tablets
More Information
FDA Label and Approval History
Guidelines for Taking Sleep Medications
Reviewed by Rose Franco, MD
Updated July 19, 2007
