There is no FDA-approved treatment for IH. However, there are several treatments approved by the FDA for use in narcolepsy, and it is common practice to use wake-promoting medications that are known to be effective in patients with narcolepsy to treat the sleepiness associated with IH (this is called “off-label” use).
Most of these treatments have not been studied to nearly the same extent in patients with idiopathic hypersomnia, and some patients with IH do not achieve adequate control of symptoms with these medications, which also in some cases may stop working over time and/or have bothersome side effects.
Researchers continue to test medications approved for other disorders, as well as novel treatments, for IH. Some patients with IH have found that Cognitive Behavioral Therapy (CBT) can also be helpful for learning skills to cope with IH.
Medications FDA-approved for Sleepiness
There are three major classes of medications approved for the treatment of sleepiness associated with narcolepsy: stimulant medications (i.e., derivatives of amphetamines), non-stimulant wake-promoting medications (e.g., modafinil and armodafinil), and sodium oxybate. In April 2019, the U.S. FDA approved a new medication (solriamfetol) for the treatment of narcolepsy and obstructive sleep apnea, although the date at which it will be available is not yet known.
Stimulants approved for the treatment of sleepiness in narcolepsy include dextroamphetamine and methylphenidate (e.g., Ritalin). While stimulants may be effective, potential side effects include dependence, aggressive behavior, and heart problems.
Non-stimulant medications include modafinil and armodafinil. While the mechanism of action of these medications is not completely known, they appear to influence brain chemistry that increases wakefulness. Modafinil has been studied in two placebo-controlled trials including patients with IH and has been shown to help with sleepiness in patients with this disorder. Modafinil and armodafinil can interact with hormonal birth control to make it less effective (learn more HERE), can result in a life-threatening rash, and are sometimes limited by associated headache.
Sodium oxybate is medication taken at bedtime (and again during the night) that promotes deep sleep and improves daytime sleepiness in patients with narcolepsy; its effects in those with idiopathic hypersomnia are not as well characterized. Of the medications listed above, sodium oxybate is the only medication that treats both sleepiness and cataplexy.
Medications FDA-approved for Cataplexy
Sodium oxybate is the only medication FDA-approved for cataplexy. Antidepressants, especially serotonin and norepinephrine reuptake inhibitors, are frequently used “off-label” to treat cataplexy.
Novel and Emerging Treatments for Sleepiness in Primary Hypersomnias
As the brain systems regulating sleepiness and wakefulness are better understood, scientists will be in a better position to design treatments that target key portions of this system. For example, based on the role of histamine in keeping people awake (and hence the common side effect of antihistamines such as diphenhydramine causing sleepiness), medications that act on histamine are under development for the treatment of excessive sleepiness. One such medication, pitolisant, is approved for the treatment of narcolepsy in Europe, but is not currently approved in the U.S. for any disorder. Pitolisant improved sleepiness in approximately ⅓ of IH patients whose symptoms did not respond well to other medications.
In the case of the primary hypersomnias related to excess activity of the GABA system, medications that could counteract this activity have potential to improve sleepiness. The antibiotic clarithromycin has been shown in a small, randomized trial to improve sleepiness and quality of life more than placebo. Another medication with actions on the GABA system, flumazenil, has also been used to treat sleepiness in IH patients whose sleepiness is not controlled with other medications.
See also the free full text journal article: A Practical Guide to the Therapy of Narcolepsy and Hypersomnia Syndromes by Emmanuel Mignot. Neurotherapeutics (2012) 9:739–752. DOI 10.1007/s13311-012-0150-9.
For further information about Treatments, including novel and emerging treatments, read our SomnusNooze articles about Treatments HERE.
Revised 5/2019 by Lynn Marie Trotti, MD, MSc, Chairperson, HF Medical Advisory Board