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FDA Approves First Drug Targeting Sleep in Fibromyalgia

Tonmya, a once-daily sublingual tablet, offers a new nonopioid option for managing fibromyalgia symptoms

Naveen Sankar S's avatar
Naveen Sankar S
Aug 21, 2025
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The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals) as the first new therapy for fibromyalgia in over 15 years. The medication is designed to improve nonrestorative sleep, a key driver of pain, fatigue, and cognitive symptoms in this chronic condition.

Study Details

Fibromyalgia affects more than 10 millio…

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