FDA Warns: Understand the Risks Before Using Z-Drugs for Insomnia
A new consumer update issued by the FDA cautions against the risks of complex sleep behaviors associated with prescription medications for insomnia, sometimes known as “Z-drugs.”
A new consumer update issued by the FDA cautions against the risks of complex sleep behaviors associated with prescription medications for insomnia, sometimes known as “Z-drugs.”
The device, which adheres to a patient's forehead to collect physiological data, previously received regulatory clearance in Australia, New Zealand, and the European Union.
The FDA has requested Philips conduct additional testing on its recalled CPAP, BiPAP, and ventilator devices, calling testing to date inadequate to fully evaluate the risks posed to users.
The ring is able to accurately measure blood oxygen levels in people with any skin tone, according to a release from the company.
Read MoreHarmony Biosciences is currently evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia in a phase 3 study, with topline results anticipated in the fourth quarter.
Read MoreIncannex received approval from the US Food and Drug Administration for an Investigational New Drug opening pivotal IHL-42X phase 2/3 clinical trial in the United States as planned.
Read MoreDuring the second quarter, Jazz Pharmaceuticals registered a 39% year-over-year growth in net product sales of its low-sodium Xywav.
Read MoreNyxoah announced operating results for the second quarter and first half of 2023, emphasizing advances in its investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of OSA.
Read MoreThe 510(k) application covers Evie Ring’s pulse oximeter which includes heart rate and blood oxygen saturation data and is expected to make it one of the first consumer wearables that is also cleared for clinical use.
Read MoreThe agencies issued a joint statement updating the public on ongoing actions being taken to resolve the shortage of prescription stimulants, a drug class often used to treat narcolepsy.
Read MoreInspire Medical Systems Inc reported second-quarter business results, marked by a series of US Food and Drug Administration regulatory approvals and submissions.
Read MoreThe IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 trial investigating IHL-42X, a cannabinoid combination product, for the treatment of OSA.
Read MorePhysicians will now have the ability to adjust the negative pressure settings of the iNAP sleep therapy device between -27 cmH2O and -122 cmH2O.
Read MoreThe FDA updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.
Read MoreThe FDA says current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse.
Read MoreThe device is indicated to reduce symptoms of primary moderate-severe restless legs syndrome and improve sleep quality in adults refractory to medications.
Read MorePhilips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
Read MoreThis recall is for certain reworked DreamStations that were also recalled in June 2021.
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