2022 in Review: FDA Approvals in Psychiatry, Pharmacotherapies for Stimulant Use Disorder, and Parasomnias Triggered by Antidepressant Medications

This newsletter summarizes the FDA-approved medications in psychiatry in 2022, presenting their most relevant facts, such as their range of benefits and common side effects.

We also discuss practical aspects of prescribing psychotropic medications for patients with stimulant use disorders, key points from a presentation on parasomnias triggered by antidepressant medications, and our practical research summaries of adult, child, and adolescent psychiatry (Quick Takes and CAP Smart Takes).

2022 in Review: FDA Approvals in Psychiatry

Sedative-Hypnotics

Daridorexant (Quviviq)

Approval:
- In January 2022, this new molecular entity received approval for insomnia in adults.
Dose:
- 25 mg–50 mg
Highlights:
- This is a dual orexin receptor antagonist with less risk for falls among vulnerable populations and no next-morning residual sleepiness.
- Participants in clinical trials fell asleep more quickly, stayed asleep longer, and reported more total sleep.
Common side effects:
- Headaches, somnolence, mild dizziness, nausea, and fatigue
Conclusion: Daridorexant is effective, well tolerated, and has fewer side effects than sedative-hypnotics. Learn more here.

Sublingual Dexmedetomidine (Igalmi)

Approval:
- In April 2022, dexmedetomidine received approval for a new indication—agitation associated with schizophrenia or bipolar I or II disorder.
Dose:
- 20 mcg–180 mcg
Highlights:
- Dexmedetomidine comes in a rapidly dissolving film strip; agitation improves as soon as 20 minutes after administration.
Common side effects:
- Drowsiness, dry mouth, hypotension, and dizziness
Conclusion:
- Dexmedetomidine is fast-acting, effective, well tolerated, and easy to administer. Learn more here.

Antidementia Drugs

Donepezil Transdermal System (Adlarity)

New formulation approval:
- In March 2022, the transdermal system was approved for mild, moderate, or severe dementia associated with Alzheimer’s disease.
Dose:
- 5 mg/day and 10 mg/day. The transdermal system is applied to the skin once weekly and continuously delivers either 5 mg or 10 mg of donepezil daily.
Highlights:
- Exposure to donepezil transdermal system is similar to oral donepezil.
Common side effects:
- Skin reactions, dizziness, headaches, muscle spasms, and irritation
Conclusion:
- This system is a well-tolerated and innovative way to deliver donepezil. Learn more here.

Nonstimulants

Viloxazine extended release (Qelbree)

New indication approval:
- In May 2022, viloxazine received an additional indication, this time for ADHD in adults.
Dose:
- 200 mg–600 mg
Highlights:
- Viloxazine was previously approved for ADHD in children (starting at age 6). This is the first approval of a novel nonstimulant treatment for adults in 20 years. It has no evidence of abuse potential.
Common side effects:
- Insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation
Conclusion:
- Viloxazine is effective and well tolerated and has no evidence of abuse potential. Learn more here.

Antidepressants

Extended-release dextromethorphan/bupropion (Auvelity)

Approval:
- In October 2022, the combination of dextromethorphan/bupropion was approved for MDD in adults.
Dose:
- 45 mg/105 mg
Highlights:
- This targets the N-methyl-D-aspartate (NMDA) and sigma-1 receptors, a new type of antidepressant. It is administered orally and improves depressive symptoms as early as week 1.
Common side effects:
- Dizziness, nausea, dry mouth, and decreased appetite
Conclusion:
- Dextromethorphan/bupropion is well tolerated, with a side-effect profile similar to other oral antidepressants. However, it is expected to be more expensive. Learn more here.

Cariprazine (Vraylar)

Approval:
- In December 2022, cariprazine received approval for an additional indication, as an adjunctive therapy to antidepressants for treating MDD in adults.
Dose:
- 1.5 mg–3 mg/day
Features:
- Cariprazine was previously approved for schizophrenia as well as manic/mixed and depressive episodes in adults with bipolar I disorder.
- It demonstrated no clinically relevant changes in metabolic parameters.
Common side effects:
- Akathisia, headache, insomnia, and nausea
Conclusion:
- Cariprazine is effective and well tolerated, and has fewer side effects. However, it needs to be included in network meta-analyses to evaluate whether there are differences in efficacy compared with other atypical antipsychotics. Learn more here.

Pharmacotherapies for Stimulant Use Disorders, With Andrew Saxon, M.D.

In this interview, Dr. Andrew Saxon discusses practical aspects of prescribing psychotropic medications for patients with stimulant use disorders. He emphasizes the use of behavioral interventions, such as contingency management and cognitive–behavioral therapy, as first-line treatment strategies. However, he also presents data regarding the use of specific medications, such as mirtazapine, methylphenidate, bupropion, prazosin, and disulfiram, among others.

Interview highlights include the following:

Mirtazapine may be effective for patients with methamphetamine use disorder. Patient education about its possible side effects is important in optimizing and maintaining adherence.
Stimulants, such as methylphenidate, are best prescribed to patients with stimulant use disorders and comorbid ADHD.

Learn more and earn 0.75 CME credits here.

Parasomnias Triggered by Antidepressant Medications: REM Sleep Behavior Disorder (RBD) and Restless Legs Syndrome (RLS)

In this presentation, Dr. Schenck shares his career-long expertise in diagnosing and treating the 2 most afflicting but underdiagnosed parasomnias: RBS and RLS. He discusses the frequency of presentation, the role of antidepressant medication in their occurrence, and how clinicians can help affected patients. Exclusive video recordings from the Minnesota Regional Sleep Disorders Center demonstrate the burden of these parasomnias.

A Clinical Case and Exclusive Videos on RBD and RLS

RBD behaviors are often aggressive and violent.
RBD involves dream-enacting behaviors with a full range of behaviors.
Loss of REM atonia and polysomnography are required for diagnosing RBD.

Learn more and earn 0.75 CME credits here.

Quick Takes: Research, Digested

Lamotrigine and Lithium Combination for Treatment of Rapid Cycling Bipolar Disorder: Results From Meta-Analysis

In this meta-analysis of lamotrigine and lithium vs lithium alone for the treatment of rapid cycling bipolar disorder, the data are not robust enough to support a firm conclusion.
Check TSH, and consider tapering concomitant antidepressants—slowly and carefully. Learn more.

Listen to or read the full volume, and earn 0.5 CME credits here.

CAP Smart Takes: Research, Digested

Low-Dose Olanzapine for Treating Adolescents With Anorexia Nervosa

Patients with anorexia nervosa appear to do better on lower dose antipsychotic augmentation. Higher doses expose them to more potentially toxic side effects.
There are no differences in eating disorder psychopathology in patients treated with olanzapine vs patients not treated with antipsychotic medication. Learn more.