Sunosi Tablet, Film Coated
Product Images NDC 81968-350

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sunosi (NDC 81968-350). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Axsome Therapeutics, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Chemical Structure (Sunosi Figure 1)

Chemical structure of solriamfetol, the active ingredient in SUNOSI. The structure includes a benzene ring, an amine group, and a carbonyl group, illustrating the molecular arrangement of solriamfetol hydrochloride.*

FDA Label Image

Sunosi Figure 10

SUNOSI 150 mg solriamfetol tablets film-coated blister card containing 7 tablets. The label includes directions for peeling the blister, NDC 81968-351-07, and notes that it is a professional sample not for sale. Labeled by Axsome Therapeutics, Inc.*

FDA Label Image

Sunosi Figure 11

SUNOSI (solriamfetol) 150 mg film-coated tablets packaging label. The front label includes dosage instructions, opening instructions for the tablet blister pack, and storage details. The labeler is Axsome Therapeutics, Inc. The image shows a blister pack containing multiple oblong tablets with push tabs beneath each tablet and dosage information prominently displayed.*

FDA Label Image

Sunosi Figure 12

Packaging label for SUNOSI 150 mg film-coated tablets, containing solriamfetol. The label indicates the product is a professional sample, not for sale, and includes the instruction to dispense with a medication guide. It notes the package contains 10 blister cards with 7 tablets each. Manufactured by Axsome Therapeutics, Inc., the label also provides storage information and contact details.*

FDA Label Image

Figure 1 (Sunosi Figure 2)

A fold change chart with 90% confidence intervals showing pharmacokinetic parameters (Cmax and AUCinf) relative to reference across mild, moderate, and severe renal impairment levels. The x-axis represents change relative to reference on a logarithmic scale from 0.5 to 8, and the y-axis lists the renal impairment categories and PK parameters measured.*

FDA Label Image

Figure 2 (Sunosi Figure 3)

A line graph from Study 1 (Narcolepsy) showing least square mean change from baseline in minutes over five test sessions (1 to 9 hours post dose). It compares SUNOSI 150 mg, SUNOSI 75 mg, and placebo groups, with SUNOSI 150 mg consistently showing the highest increase and placebo the lowest. Error bars represent standard error.*

FDA Label Image

Figure 3 (Sunosi Figure 4)

A line graph from Study 2 (OSA) showing Least Square Means and Standard Error for change from baseline in minutes across test sessions from 1 to 9 hours post dose. The graph compares four groups: SUNOSI 150 mg, SUNOSI 75 mg, SUNOSI 37.5 mg, and placebo, illustrating the time-course of treatment effects over five test sessions.*

FDA Label Image

81968-350-01 (75 mg 30 Count Bottle Label)

Label for SUNOSI (solriamfetol) tablets, 75 mg strength, Schedule IV controlled substance. The label states there are 30 film-coated tablets per bottle. It includes dosage instructions referencing the package insert, storage conditions of 20°C to 25°C with permitted excursions, and a caution to keep out of reach of children. Distributed by Axsome Therapeutics, Inc., New York, NY.*

FDA Label Image

81968-350-01 (150 mg 30 Count Bottle Label)

SUNOSI (solriamfetol) tablets 150 mg film-coated tablet label displaying the proprietary and generic names, strength, and controlled substance schedule (CIV). The label shows storage instructions, dispensing requirements, distributor information (Axsome Therapeutics, Inc.), and package quantity of 30 tablets. The NDC number and a barcode are also visible.*

FDA Label Image

81968-350-10 (75mg Physician Sample Label)

SUNOSI (solriamfetol) 75 mg film-coated tablets blister card containing 7 tablets. The label includes the dosage strength, product name, and pharmacy dispensing instructions. It is distributed by Axsome Therapeutics, Inc., and designed for oral use with prescription status noted. The blister card features peel-off indicators for each tablet.*

FDA Label Image

81968-351-10 (150 mg Physician Sample Label)

SUNOSI 75 mg film-coated tablets packaging label displaying dosage strength and tablet push-through instructions. The label includes directions for safely pushing tablets out of the blister pack, storage conditions, and a warning to keep out of reach of children. It also provides contact information for the labeler, Axsome Therapeutics, Inc.*

FDA Label Image

Sunosi Figure 9

SUNOSI 75 mg film-coated tablets packaging label showing the product name and strength prominently in purple text with a yellow band. The label includes the active ingredient solriamfetol, professional sample designation, and a statement that it is not for sale. Distributed by Axsome Therapeutics, Inc., the label also advises to dispense with medication guide and includes storage instructions and contact information. The package contains blister cards of 7 tablets each.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.