Azurity Pharmaceuticals, Inc is recalling 1 lot of Zenzedi^® (dextroamphetamine sulfate) 30mg tablets due to a mislabeled package.

The recall was initiated after a pharmacist from Nebraska reported that a bottle of Zenzedi 30mg tablets contained carbinoxamine maleate tablets. The affected product, Zenzedi (dextroamphetamine sulfate tablets, USP) 30mg tablets; NDC No. 24338-856-03; Lot No. F230169A; Exp. Date 6/2025, was distributed nationwide to wholesalers between August 23, 2023 and November 29, 2023. 

Zenzedi is a schedule II controlled substance indicated for the treatment of attention deficit hyperactivity disorder and narcolepsy. Carbinoxamine maleate is an antihistamine indicated for the symptomatic treatment of allergic and vasomotor rhinitis, allergic conjunctivitis, urticaria, angioedema, reactions to blood, and dermatographism; it is also indicated for use as an adjunct in anaphylaxis.

The Zenzedi 30mg tablet can be identified by its light yellow color and hexagonal shape. The tablet is debossed with “30” on one side and “MIA” on the other side. The carbinoxamine maleate 4mg tablets that were reported by the pharmacist were white round tablets with imprints of “GL” on one side and “211” on the other side.

Due to the sedating effects of carbinoxamine, there is a possibility of functional impairment in patients who unknowingly consume the drug instead of Zenzedi. To date, the Company has not received any reports of serious adverse events related to this recall. 

Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.

Rajnish Mehrotra, MD, from the University of Washington School of Medicine in Seattle, and colleagues compared the effectiveness of CBT-I, trazodone, and placebo for insomnia in a randomized, multicenter trial involving patients undergoing long-term hemodialysis conducted in 26 dialysis units. Overall, 126 patients with chronic insomnia were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo (43, 42, and 41 patients, respectively).

The researchers found that the change in the Insomnia Severity Index (ISI) score from baseline to 7 weeks was no different for CBT-I or trazodone vs placebo (−3.7, −4.2, and −3.1, respectively). From baseline to 25 weeks, there was no meaningful change observed in ISI scores: −4.8, −4.0, and −4.3 with CBT-I, trazodone, and placebo, respectively. Serious adverse events, especially serious cardiovascular events, occurred more often with trazodone (annualized cardiovascular serious adverse event incidence rates: 0.05, 0.64, and 0.21 with CBT-I, trazodone, and placebo, respectively).

“Given the high burden of insomnia in this population and high priority placed by patients for symptom relief, more trials are needed to investigate additional therapies for this condition,” the authors write.

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The prescribing information for Dayvigo^® (lemborexant) has been updated to include clinical trial data related to the use of the insomnia medication in patients with severe obstructive sleep apnea (OSA) and moderate to severe chronic obstructive pulmonary disease (COPD).

Dayvigo is an orexin receptor antagonist indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients. To fulfill a postmarketing requirement, Eisai conducted short-term clinical trials to evaluate the respiratory depressant effect of lemborexant in patients with compromised respiratory function.

The effect of lemborexant on respiratory function in patients with OSA was evaluated in 2 randomized, placebo-controlled, 2-period crossover studies (ClinicalTrials.gov Identifier: NCT03471871, NCT04647383). In both trials, patients were assessed following 8 consecutive nights of treatment with lemborexant 10mg.

Among the 37 patients with mild OSA (apnea-hypopnea index <15 events/hour of sleep), the mean treatment difference (lemborexant-placebo) on day 8 for the apnea-hypopnea index was reported to be -0.06 (95% CI, -19.5, 1.83). Among the 33 patients with moderate to severe OSA (apnea-hypopnea index ≥15 events/hour of sleep), the mean treatment difference on day 8 for the apnea-hypopnea index was 0.80 (95% CI, -4.88-3.29).

Lemborexant 10mg dosed once daily was also evaluated in 30 patients with moderate to severe COPD (ClinicalTrials.gov Identifier: NCT04647383). The mean treatment difference on day 8 for the mean peripheral capillary oxygen saturation during sleep was 0.47 (95% CI, 0.07-0.87). The treatment was not studied in patients with FEV₁ < 30% of predicted.

Due to the short duration of the studies, in addition to other limitations, clinically meaningful respiratory effects of lemborexant cannot be excluded and should be considered when prescribing to patients with compromised respiratory function.

Dayvigo is supplied as 5mg and 10mg tablets. The recommended dose should be taken immediately before going to bed, with at least 7 hours remaining before the planned time of awakening.

HealthDay News — Digital cognitive behavioral therapy for insomnia (dCBT-I) is effective for patients with insomnia, with the optimal treatment including a combination of medication and dCBT-I, according to a study published online April 11 in JAMA Network Open.

Menglin Lu, from Zhejiang University in Hangzhou, China, and colleagues conducted a retrospective cohort study to examine the clinical effectiveness, engagement, durability, and adaptability of dCBT-I. A total of 4052 patients were selected for treatment with dCBT-I, medication, or combination therapy (418, 862, and 2722, respectively); outcomes were compared at months 1, 3, and 6.

The researchers found that participants receiving both dCBT-I and combination therapy had significant reductions compared with the change in the Pittsburgh Sleep Quality Index score at 6 months for patients receiving medication alone (from a mean of 13.51 to 7.15 and 12.92 to 6.98, respectively, vs 12.85 to 8.92); the effect of dCBT-I was comparable to that of combination therapy but showed unstable durability. During the first three months, the outcomes of dCBT-I improved steadily and rapidly, then fluctuated. Higher response rates were seen with dCBT-I and combination therapy compared with medication. Significant benefits were seen from dCBT-I and combination therapy in secondary outcomes.

“These positive findings provide clinical evidence that dCBT-I contributes to meaningful sleep improvements,” the authors write. “Given the unstable durability of dCBT-I at six-month follow-up, the design, implementation, and delivery of dCBT-I in the practice setting warrants further investigation.”

One author disclosed financial ties to Hangzhou slan-health.

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The Food and Drug Administration (FDA) has granted final approval to Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

Lumryz is an extended-release formulation of sodium oxybate, a central nervous system depressant. Its therapeutic effects are believed to be mediated through GABA_B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.

The approval was based on by data from the phase 3 REST-ON study (ClinicalTrials.gov: NCT02720744), which included 212 patients with narcolepsy. Study participants were randomly assigned to receive Lumryz (titrated to 4.5g, 6.0g, 7.5g, and 9.0g) or placebo once nightly for 13 weeks.

The co-primary endpoints of the study included improvements on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Improvement (CGI-I) in daytime sleepiness, and mean weekly cataplexy attacks, recorded on the Sleep and Symptom Daily Diary.

Results showed that patients treated with Lumryz 9g achieved highly significant and clinically meaningful improvements across all 3 endpoints compared with placebo at week 13:

• MWT: 10.82 minutes vs 4.7 minutes; difference from placebo: 6.1 (95% CI, 3.52-8.75); P <.001.
• CGI-I (% of patients much/very much improved): 73% vs 32%; odds ratio 5.6 (95% CI, 2.76-11.23); P <.001.
• Mean weekly cataplexy attacks: -11.51 vs -4.9; difference from placebo: -6.7 (95% CI, -9.32, -3.98); P <.001.

Statistically significant improvements on all 3 endpoints were also observed with the 6g (week 3) and 7.5g (week 8) doses of Lumryz compared with placebo (P <.001).

The most common adverse reactions reported with treatment included nausea, dizziness, enuresis, headache, and vomiting.

“This long-awaited therapy for people living with narcolepsy fills a critical unmet need by avoiding the burden of a second middle-of-the-night dose that immediate-release oxybate products require,” said Michael J. Thorpy, MD, an investigator from the REST-ON phase 3 trial and Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. “The once-at-bedtime dosing regimen of Lumryz may help restore a more natural sleep-wake cycle.”

Lumryz is supplied in packets with granules that are mixed with water to create an oral suspension. The carton also contains a mixing cup. The dosage strengths include 4.5g, 6g, 7.5g, and 9g per packet of sodium oxybate. The product is taken orally as a single dose at bedtime.

Lumryz is expected to be available in early June.

The Food and Drug Administration (FDA) has cleared the Vivos CARE (complete airway repositioning and/or expansion) oral appliances for the treatment of severe obstructive sleep apnea (OSA).

The Vivos CARE appliances include the DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance, which were all previously approved for use by patients 18 years of age and older with mild to moderate sleep apnea. Customized to each patient, the device consists of an upper tray, lower tray, or both and is designed to gradually reposition the tissue at the back of the throat, thereby increasing the patency of the airway.

The FDA clearance was based on data from 73 patients with severe OSA who were treated with the Vivos suite of oral appliances. Findings showed that 80% of patients experienced an improvement of at least 1 classification or at least 50% improvement in the apnea hypopnea index. Overall, 97% of patients saw an improvement or no worsening of OSA symptoms. The average treatment time was 9.7 months. 

“Before [the FDA clearance], severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries,” said Kirk Huntsman, Chairman and CEO of Vivos. “Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”

Training is provided to dentists and other medical professionals interested in prescribing Vivos oral appliances. Additional information for providers can be found here.

HealthDay News — The US Food and Drug Administration has issued another warning about certain sleep apnea machines made by Philips Respironics. Already the subject of a 2021 recall, some of the company’s repaired continuous positive airway pressure (CPAP) machines may still be dangerous to use, the agency said in an alert issued Friday.

The original problem with some of the machines was that foam that is meant to dull noise was breaking off from inside the machine and going into the mouths of people using the unit for sleep apnea. Inhaling the foam can cause “serious injury, which can be life-threatening,” Philips noted in its original recall notice.

The latest issue with some of the machines is that the company gave repaired machines the wrong or duplicate serial numbers, the latest FDA alert said. That may lead to the devices delivering the wrong prescription to sleep apnea patients. If receiving the wrong prescription, patients may not receive any CPAP benefits.

Philips’ Friday statement acknowledged the repair issues, including that a “limited amount [1200] of remediated first-generation DreamStation CPAP devices had been incorrectly programmed with either an incorrect serial number or a duplicate serial number.” The company is notifying patients if their machines may provide them with the wrong prescriptions.

The FDA has tracked complaints numbering 98,000 since the 2021 recall. People have reported having respiratory problems, pneumonia, dizziness, chest pain, infections, and cancer. The company said it has received 43 complaints about the repaired machines. No one has reported injury or death.

More than 20 different Philips devices have been recalled, including the A-Series BiPAP ventilators, the DreamStation CPAP machines, and the Trilogy 100 and 200 style ventilators.

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