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Adult Down Syndrome Center

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Recent FDA-approval of medication for sleep apnea

January 23, 2025 05:00 AM

Sleep apnea

Sleep apnea is more common in people with Down syndrome. Of the three types of sleep apnea (obstructive, central, and mixed), obstructive sleep apnea is the most common type in people with Down syndrome. There are several treatment options, but positive airway pressure (CPAP or BiPAP) is prescribed most frequently to treat sleep apnea. In December 2024, a new option became available when the FDA approved a medication for obstructive sleep apnea.

What is the medication?

In December 2024, the FDA approved tirzepatide opens in new window (that goes by the trade names Zepbound and Mounjaro) for sleep apnea. Tirzepatide was previously approved for treating type 2 diabetes mellitus and promoting weight loss. In reviewing a study on tirzepatide's effect on sleep apnea opens in new window, the benefit seems to be related to the weight loss rather than a direct effect of the medication on sleep apnea.

Is it effective in people with Down syndrome?

Research opens in new window has shown that sleep apnea severity increases as the weight of a person with Down syndrome increases. However, we were not able to find research that demonstrated the opposite – that weight loss reduces sleep apnea severity in people with Down syndrome. Our clinical experience has been that weight loss can be an effective treatment for sleep apnea in at least some people with Down syndrome.

While the study with tirzepatide that led to the FDA approval was not done in people with Down syndrome, it is possible that tirzepatide may have the same effect on weight and sleep apnea in people with Down syndrome. However, research is needed to determine how effective tirzepatide is for people with Down syndrome and sleep apnea.

What other treatments are available?

Treatments for obstructive sleep apnea include: 

  • Positive airway pressure (CPAP or BiPAP) opens in new window

    • Many people with and without Down syndrome have difficulty using CPAP or BiPAP.

  • Positional treatment opens in new window

    • Many people have sleep apnea or increased sleep apnea when sleeping on their back. Various methods are available to encourage sleeping on one's slide (and discourage sleeping on one's back) in an effort to reduce sleep apnea.

  • Mouth pieces or other oral appliances opens in new window

    • These are used to keep the airway open when sleeping. 

  • Surgery opens in new window

    • Surgical options include removal of the tonsils and adenoids (typically in children) and upper airway stimulation, among others.

Are there other medication options?

For those with persistent sleepiness from sleep apnea (even if they are successfully using other treatments), the stimulants armodafinil and modafinil are FDA-approved. Solriamfetol is another medication that is not considered a stimulant (but does have some abuse potential) that is also FDA-approved for persistent sleepiness.

A combination of two medications – atomoxetine and oxybutynin – has shown benefit in treating obstructive sleep apnea but it is not approved by the FDA. When a physician prescribes these medications for sleep apnea, it is considered “off-label,” meaning that the drugs are FDA-approved but for different conditions. They are not available as a single combination medication. Atomoxetine (Strattera) is used to treat attention deficit disorder. Oxybutynin (Ditropan) is used to treat overactive bladder. Together, they have been studied for sleep apnea and shown to reduce sleep apnea in the non-Down syndrome population opens in new window. A small study done in children with Down syndrome opens in new window showed some, but limited, benefit in treating sleep apnea.

Brian Chicoine, MD

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