The Whitworths of Arizona, bringing science to you in everyday language.

Friday, February 15, 2019

What about Provigil?

(Some words are italicized the first time they appear. These are defined below this post.) 

Way back in 2008, we had a friend, Bob, whose father had LBD. Dad also had excessive daytime sleeping (EDS), a common LBD symptom. His doctor prescribed Provigil and it did keep Dad awake more. But Bob insisted that it made his dad more alert too. "It even stopped most of his hallucinations," Bob told us.

We knew that Provigil was a psycho-stimulant, a brain stimulating drug approved for use with EDS, and so it was an appropriate drug for Dad's excessive daytime sleeping. We also knew that college students have used it and other psycho-stimulants, like Ritalin and Adderall, to help them stay awake and cram for tests and so the idea that it improved Dad's cognition wasn't off the wall. Of course, this off-label (and often non-prescription!) use by healthy students is not encouraged. But might its use by someone like Bob's dad be very helpful for more than just EDS? Some people thought so, but there was little if any scientific proof.

Fast forward to 2017 and two articles, one about the generic Provigil, modafinil, and another about its close cousin, Nuvigil. In the first, researchers used MRI imaging of the brain to find out if and in what areas of the brain, modafinil caused increased activity. In the second, researchers explored the effectiveness, safety and tolerability of Nuvigil when used for EDS associated with dementia with Lewy bodies (DLB).

It is believed that Provigil and its close cousin, Nuvigil, both work by improving the function of dopamine. Dopamine in the midbrain acts to control mobility as any PD care partner knows. But in other parts of the brain, it facilitates cognitive functions. Researchers in the first study found that modafinil significantly increased activity in the areas of the brain controlling vision, attention, inhibition and the working memory.

This not only supports the theory about how Provigil works. It  shows how Provigil likely helped those those college students to focus better and have better access to the thinking skills that operate in their working memory. And it looked like Bob could be right in his claim that Provigil was the cause for the improvement of his dad's hallucinations and his better alertness. But did any of this last?

Probably not. The first study was done with only one dose per subject and so continuity was not an issue. However, the researchers in the second article did administer Nuvigil for various periods of time but they found no improvement in cognitive function. The critical term here is "over time." The college kids didn't get smarter over time either. Their skills were simply improved temporarily, long enough for them to get through their tests. Even without the other issues, that's a good reason to discourage this practice. For the student's learning to be useful in the future, it needs to last, not disappear after a quick short-term boost!

It is admittedly different for a person with dementia, where any boost, even short term, is welcome. However, its lack of improvement over time is likely why doctors seldom prescribe it off label to assist FDA approved dementia drugs. Of course, LBD is very individual. Maybe in Bob's dad's case, it did last longer.

But are these drugs safe? The researchers in the second article found that the drug was reasonably safe for people living DLB. Thus it is probably equally safe for someone living with PDD. Addiction is always a concern with any psycho-stimulant, but since Provigil and its relatives have a different action than most other stimulants, this really isn't an issue for them. In addition, when considering a drug you don't plan to stop, addiction becomes less important.

Side effects for these drugs are usually mild but even so, people with a history of heart disease or arrhythmia should avoid stimulants in general, including these. The most common side effects are GI related: nausea, dry mouth, anorexia and diarrhea.

Nuvigil is made by a different company than Provigil. While its  slightly different formula provides the same general action,  it is milder and longer acting.That is, if a person was taking two 100mg doses of Provigil per day , they'd need to take one 250mg dose per day of Nuvigil for the same effect. Likely due to Nuvigil's longer and milder action, doctors usually prefer it over Provigil and thus, so do insurance companies. If your insurance doesn't cover this drug, or if the co-pay is high, do ask about generic Provigil. It will be much less expensive. Nuvigil doesn't come in a generic form.

The bottom line is that these drugs are reasonably safe, work well for EDS and may provide an extra short-term bonus of better cognition and/or fewer hallucinations to some people.

armodafinil: The generic name for Nuvigil
DLB: Dementia with Lewy bodies. The Lewy body dementias that starts with cognition issues.
dopamine: A neurotransmitter that facilitates mobility and cognition
EDS: Excessive daytime sleeping. A DLB symptom identified in the official diagnosis criteria.
generic: Non-brand drug name
GI: Gastro-intestinal, concerning the stomach and intestines
modafinil: The generic name for Provigil and for the less expensive generic Provigil
Nuvigil: A milder and longer acting cousin of Provigil. Not available as a generic.
off-label: Used for a condition that the drug is not approved for.
PD: Parkinson's disease, a Lewy body disease and often, a predecessor of LBD
PDD: Parkinson's disease with dementia. The Lewy body dementia that starts with motor issues.
Provigil: A drug accepted by the FDA for treatment of EDS.
psycho-stimulant: brain (psycho)-stimulating drug
working memory: used for holding data while performing thinking skills

The two articles:
Punzi, M. et al. (2017) Modafinil-Induced Changes in Functional Connectivity in the Cortex and Cerebellum of Healthy Elderly Subjects. Frontiers in aging neuroscience, 9, 85. doi:10.3389/fnagi.2017.00085

Lapid, M. Boeve, B. et. al. (2017). Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study. Dementia and geriatric cognitive disorders, 43(5-6), 269-280.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

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